Vice President, Navitas Data Sciences
Shrishaila has done Masters in Biotechnology from Bangalore University & have more than 16 years of experience across Drug Development.
He is currently working as Vice President at Navitas Data Sciences, heading the Statistical Programming department, India.
He is also working as "CDISC Volunteer" & “PhUSE India Membership” officer.
He is also supporting “R Package Validation Framework” and “Open Source Technologies for Regulatory Submissions” Projects in PhUSE working group “Data Visualisation and Open Source Technology in Clinical Research (DVOST)”.
He has authored an International book “FDA Clinical Outcome assessments and CDISC QRS supplements” under “Clinical disciplines” category with LAMBERT Academic Publishing group.
He has exposure to various Analytical tools like SAS (Base and Advance Certified), R, PYTHON and CDMS Tools like Inform (EDC), Medidata Rave(EDC), Clintrial and Oracle Clinical LSH.
He is a passionate Speaker & active in most of the conferences in the industry. His hobbies are Reading, playing Table tennis etc.
Director, Real World Evidence and Market Access at Covance
Madhur Garg is Director, Real World Evidence and Market Access at Covance.
Madhur has worked across global and regional roles in the pharmaceutical industry. He is a market access and pricing strategist with health economics and outcomes research background. His career has spanned across Europe and Asia working for various life science companies (including J&J, Lundbeck & LEO Pharma). He possesses experience with all major payers and health technology assessment (HTA) bodies across Europe, North America, Middle East and Asia Pacific.
Madhur holds a Master’s in Medical Sciences (specialization in global health, health economics) from Karolinska Institute, Stockholm and Master’s in Health Administration from Tata Institute of Social Sciences, Mumbai.
He serves as a board of studies member at Manipal University and is an adjunct faculty for health economics. He is a speaker/ faculty for HEOR, MA & RWE at various forums and peer reviewer for journals.
He continues to be an active learner esp. in data analytics/ HEOR/ RWE and completed an executive course in advanced Big Data Analytics from IIM- Ahmedabad in 2019.
AVP – Biostatistics & Statistical Programming, TCS Life Science
Tushar Sakpal is working as AVP for the Biostatistics and Statistical Programming (B&SP) group within TCS Life Science. He is currently responsible for the North America B&SP delivery across various accounts. As a domain consultant, responsible for working closely with TCS Platform team to develop solutions based on metadata drive, AI/ML, CDISC 360 based concepts. Tushar has presented various topics automations and metadata driven solution, including concepts around graphical databases. He is a frequent speaker / chair / panelist at SCDM, PhUSE, DIA, IASCT, ConSPIC, ISCR and other conferences. He brings in 19+ years of Clinical Development expertise with prior experience in Pfizer, GE Capital, Reliance Life Sciences, Siro ClinPharm and PharmaNet (now Syneos). Prior to joining TCS, he worked with PharmaNet-I3 as Principal Biostatistician. He has earlier worked as Manager - Biostatistics & Statistical Programming at Siro ClinPharm, Lead Statistical Programmer at PharmaNet and prior to that has worked with RCRS, Pfizer and GE Capital. He has around 19+ yrs. of experience and has expertise in Biostatistics, Statistical Programming and Data Management. He has good understanding of CDISC guidelines, Policy 70 requirements, eSubmission package requirement, EudraCT / CT.Gov requirements, AI/ML based concepts.
In TCS, Tushar is involved in following key strategic initiatives:
Automation Projects: For US based customers, Tushar, is closely working with the TCS IT team to develop various automations using agile framework, MFDMTM ideology, ML/AI techniques and applying cognitive methods. Tushar holds IP for one of the TCS ADD platform solutions.
Metadata Based Solutions: Provide domain inputs and work closely with the TCS ADD platform team to develop metadata repository based solution for clinical trails. Discuss AI/ML based concepts to automate SDTM package.
CDISC Initiatives: Focus on CDISC 360 based concepts and its implementation at TCS. Drive core CDISC team involved in streamlining CDISC related processes within TCS.
He holds a Master’s Degree in Statistics and has completed Six Sigma Green Belt Certification (GE Capital) and is a strong believer in systems and process and has a strong niche for process improvement. He loves watching & playing cricket, listening to music and being with his family in his spare time.
Director, Data Management, Covance
Tanusha Dutta is a versatile professional leader with proven industry experience of around 17 years. She brings to the team a blend of core domain expertise across therapeutic areas, along with diverse operational adeptness in handling large, global delivery teams.
As a strategic leader, she is capable of wearing many hats, changing them on the fly and quickly picking up new hats along her professional journey. Her success mantra orbits around the human side of leadership….empowering, recognizing and championing talents while building an environment where all employees can thrive.
In her current role, Tanusha manages a team of over 150 data management professionals, ensuring seamless delivery, high customer satisfaction index and develop strategies to stay competitive in the market. She has pioneered several process improvement initiatives and steered global implementation of these processes, which resulted in improved operational efficiency and profitability. She has been recognized for driving a number of people centric initiatives with a focus to retain top talents and strengthening the organization’s cultural beliefs. She is an active core committee member of the India WEN chapter.
Prior to joining Covance, Tanusha has held numerous other leadership positions across the CRO, BPO and ITeS industries. She has been featured in company's’ websites for accelerated career growth stories and customer testimonials.
When not at work Tanusha enjoys travelling and discovering new places, cherishing motherhood and being engaged with several social and charitable causes.
Director – Data & Analytics, Eli Lilly India
Priyadharshini Lobow, Director – Data & Analytics, Eli Lilly India is a seasoned CDM leader with experience in managing global teams across clinical data programming and clinical data management. An engineer by training and a PMP certified professional, currently pursuing Masters in Business at IIM-K, Priya has diverse experience across Therapeutic Areas and device studies, technology platforms, transition and transformation management. In her current role, Priya leads the CDM capacity and capability building efforts at Eli Lilly India.
Debu Moni Baruah
Manager, Software Development IQVIA
Debu Moni Baruah's background spans the fields of clinical data management, research, marketing, and data analytics. He is lean six sigma black-belt and MMC metrics visualization certified. Debu has led key innovation projects with a major focus on the areas of people, process, and technology in CROs and technology companies. Debu has authored CDM SOPs, WIs, and over 40 articles, including peer-reviewed research papers, and presented his findings in several international and national conferences. Debu is a co-editor and an editorial board member of the Journal of SCDM and also a member of the SCDM academic committee. Debu has chaired sessions in the global SCDM annual conferences, acted as a speaker and led industry workshops in multiple SCDM India conferences, and invited as an expert faculty to the DIA annual conference. In recent activities, with an objective of bringing the academia closer to the industry, Debu has led multiple webinars and full day conferences. He was invited by 6 academic institutes where he could collaborate with more than 56 industry speakers and could virtually connect with over 1500 students, industry representatives and academicians from 15 countries during the COVID 19 situation. Debu is a wannabe artist and in his free time, he loves sketching and painting.
Currently, Debu is serving as a manager, software development at IQVIA.
Senior Vice President, India Country Head & Managing Director & SBU Head - Clinical Trial Supplies & Logistics Parexel International
Having recently moved from USA as the India Country Head & Board of Director, he is responsible to develop strategic direction & provide the leadership and vision necessary to grow the 5,400 plus India organization. He also heads Parexel’s Global Clinical supplies & Logistics business which also includes the global distributions centers & infrastructure.
Lived & worked in 8 countries & 4 continents, Sanjay brings over +23 years of experience in Global P&L management, Logistics & Supply chain management, Sales & Marketing, M&A's, Operations & People management.
Previously at DHL as the VP for Life Sciences and Healthcare APAC, based in Singapore he was responsible to manage the Global Logistics & Supply Chain business for the top Life Science & Healthcare Customers across all DHL BU’s within APAC. He was a member of the DHL Life Sciences and Healthcare Board.
Sanjay holds a Master’s Degree in Marketing Management & a Bachelor’s Degree in Commerce & Economics. He also has a Professional Diploma in Software Technology and Systems Management.
Senior Director, Data Management, Parexel International
Dr Roopa Basrur is a member of the SCDM India Steering Committee.
After nearly two decades in medical writing, Roopa decided to do something different in the clinical research arena. She now heads the clinical data management teams for India and is responsible for operations and delivery. Her experience is in medical communications, regulatory and safety writing, and, leading and developing teams in both a Pharma and CRO set up. She is one of the founders of the All India Medical Writers Association (AIMWA).
Roopa has previously held an administrative lead position for the Parexel Bengaluru offices and is actively involved in the company’s global gender partnership and LGBTQ+ programs. She co-leads the Parexel India D&I Committee.
She has an educational background in medicine, medical law and ethics and a professional development certificate from the European Medical Writers Association (EMWA).
Roopa is based in Bengaluru, India.
Director – Global Clinical Development Delivery Operations
Results oriented leader with 25+ years of experience in managing global delivery operations with team size of 500+ resources. A proven consistent performer, passion to innovate, build strategy and execute innovative solutions to achieve consistent business result. Proven expertise in technology enabled business transformation and high performing team supporting global pharma, device and Biological customers.
Accomplished and performance-driven individual with 25+ years of experience in clinical operations, project and information management, and product quality within the pharmaceutical industry. Proven record of success in creating/implementing concepts for clinical development, devising and executing strategic growth strategies and streamlining business processes. Skilled at leading global projects from inception to completion, preparing/employing consistent and realistic business plans and control structures for projects and ensuring completion within time and under budget. Excellent team player with deep experiences in cross-functional teams with strong communication skills. Broad expertise in managing global strategic programs, delivering high-quality systems, implementing and deploying technology, managing multiple work streams, and achieving results within multi-cultural and geographically diverse teams. Excellent written and verbal communication skills, strong attention to detail, highly motivated, flexible with a problem-solver mindset.
Managing large Global Delivery Team catering to multiple Phama companies. Team consist of varied Clinical System experience not limiting to EDC, ECOA, IRT, CTMS, Reporting and Analytics, Business Consulting, implementation and validation, ITIL support, Study Setup and Post production management, Business Process Transformation etc.
Director Operations, Cenduit India Services Pvt. Ltd
He has over 17 years of experience in global delivery, eClinical operations and operational excellence.
Sujit has worked for world-class services organizations including Pfizer, Johnson and Johnson, Cognizant and Tata Consultancy Services (TCS) in both Clinical Operations and eClinical. Prior to joining Cenduit, Sujit was Associate Vice President, Operations at Tata Consultancy Services (TCS), leading a very large Clinical Data Management operations unit for a top 5 global pharmaceutical company. Before TCS, Sujit was with Cognizant where he was part of the Life Sciences Clinical Data Management operations where he played multiple roles including transition management, business transformation and operational excellence.
Sujit holds a bachelors’ degree in Pharmacy from the Bombay College of Pharmacy and an MBA (systems and technology) from Narsee Monjee Institute of Management Studies. Sujit is also a visiting faculty with multiple prominent colleges in Mumbai including the academy of clinical excellence with Bombay College of pharmacy and St. Xavier’s College.
Head - Stats and Programming group, Parexel India
Mahesh currently heads the Stats and Programming group for Parexel India. In this role, he is responsible for also driving innovation in the clinical trials space for Parexel. Prior to this role, Mahesh was a co-founder of Sineflex Solutions LLP, a consulting firm focused on enabling and accelerating innovation in the healthcare space. He was also the head of the BIRAC funded med-tech accelerator located at the Centre for Innovation and Entrepreneurship, IIIT Hyderabad. In this role, Mahesh was responsible for mentoring startups in the medtech space, and helping them scale their products and solutions. Mahesh Iyer has over 20 years of experience in research and development in healthcare. He has been responsible for guiding many products through the development life-cycle. Before co-founding Sineflex Solutions, Mahesh was at Novartis in various roles, including Site Head, Biostatistics at Hyderabad, and Global head for Exploratory Safety and Statistical Analytics. Prior to Novartis, Mahesh worked with Bristol Myers Squibb and Boehringer Ingelheim.
Mahesh brings a strong analytical mind-set, deep insights into healthcare development and a proven record of implementing innovative solutions in the healthcare domain. Mahesh is passionate about enhancing industry academia collaboration; he set up one of the first part-time Ph.D. program in Statistics for Novartis associates, teaches at a number of Indian universities and has chaired multiple conferences over the years. He is currently Secretary of the Indian Association for Statistics in Clinical Trials and President of the International Indian Statistical Association, India Chapter.
Apart from his functional activities, Mahesh has led various organizational developmental activities and trainings. He is a certified coach in the areas of emotional intelligence, assessment centers, and psychometric evaluations. Mahesh has completed his Ph.D. in Statistics from Temple University, Philadelphia.
Global Head of Data Science, George Clinical
Abby Abraham currently serves as the Global Head of Data Science at George Clinical and also co-leads the global Centre for Innovation in the organization. Abby has 20 plus years of experience in pre-clinical and clinical research. Abby has worked in multiple areas such as Clinical and data-driven Monitoring, Project Management, Operations management, and technology adoption. In the past, Abby has held various leadership roles in global CROs. Before joining George Clinical, Abby was the Vice President of Data Analytics & RBM at OmniComm Inc, the USA after a successful stint in entrepreneurship at Algorics.
European Clinical Domain Lead, Accenture
Christina is passionate about changing the clinical trial process to make clinical trials and research truly human centric, utilizing all aspects available from experience design to cutting edge technology. She believes in extensive collaboration across all stakeholders on a global scale to foster research and patient outcomes.
As the European Clinical Domain Lead for Accenture’s Life Sciences practice, she is well positioned to make a difference.
She is working on a global level with Accenture’s Life Sciences clients on optimizing the end to end Clinical Trial process. Her work encompasses collaborating with a wide range of team members across the globe to change the way clinical trials are conducted – now and in the future.
Her work ranges from digital clinical trial set up and the implications of these changes for all clinical trial participants, over integrations of RWE and devices into the system infrastructure and the roll out on an enterprise level, to Clinical Trial Management System and Data Flow processes.
Whether it comes to assessing data flow processes, enhance the current clinical trial processes with automation and machine learning, and bring innovative solutions to Accenture’s portfolio – she believes that an open mind and the willingness to push boundaries and question the status quo will make a true difference to Research and Development – and ultimately enable us to treat patients better.
Global Head-CDM Functional Service Provider (FSP), Covance
Arshad is a Physician with over 20 years’ experience in the health sciences industry. His career path has been in Acute Patient Care at a Tertiary Care Center, Medical Affairs, Medico-marketing, followed by Life Sciences Consulting, Software Product Management, eCOA and Clinical Data Management. He has managed CDM teams for all phases including early development, late phase and observational studies. Currently, Arshad is the global head of CDM Functional Service Provider (FSP) organization at Covance.
Director, DM, ICON PLC
I have around 18 years of Industry experience which includes 16 years of Data Management along with 14 years of people and project management experience. Currently working as a Director, DM at ICON PLC and have worked with Accenture and IQVIA in the past.
Have extensively worked on Operations planning and management along with building resilient business operations with Intelligence, Innovation, Insights and Expertise with focus on building best leaders for now and future through effective Training, Coaching and Empowerment of people.
Chief Operating Officer, Cytespace Research Private Limited
A total of 22+ years of Clinical Research experience across Clinical Operations, Clinical Data Management / Biostatistics and Clinical Trial Sites in India and China.
Bhavesh is leading a multi disciplinary team of Clinical Development professionals in Bangalore and Clinical Trial Sites in 20+ cities across India.
Trained in the various programs at IIM Ahmedabad (India) and Forum Corporation (USA) on building Strategies, Leadership and on Coaching. Have participated in various clinical research conferences in India and abroad.
General Manager & Domain Delivery Head, Life Sciences, TCS Limited
22+ years of Clinical R&D services industry experience (Clinical Data Management, Statistics & Programming, Medical Writing, Regu la tory Affairs and Pharmacovigilance).
12+ years in TATA Consultancy Services (2008 till date) date): Roles handled includes Delivery/Operations, Pre sales and Solutions, Domain Consulting, Sales and Client Relationship Management in US.
~4 years in Quintiles Transnational (IQVIA), Bangalore (2004 2008): Managed CDM delivery across therapeutic areas and geographies for global top 20 pharmaceutical companies . Supported Business Planning & Market Research for Global Data Management.
~6 years in GlaxoSmithKline Pharmaceuticals in Bangalore (1998 2004): Project Managed large Phase 3 global programs in Vaccines Clinical Data Management captive center.
Worked as Research Assistant in the Department of Biochemistry, Indian Institute of Science, Bangalore (1996 1998).
Statistical Programming & Analysis Programming Standards Lead – India, Pfizer
Jeba Kumar has over fourteen years of experience in Pharmaceutical and Clinical Research Organization. Jeba has played multiple roles in his span of 14 years that includes, leading large teams, project management, coaching and mentoring, innovating & developing new applications to support Clinical Data Management and Statistical Programming. In the current role as Programming Standards Lead, he is responsible for leading and managing the implementation, delivery, and maintenance of programming standards, including the training and support of programming team utilizing Pfizer standard reporting software within the Clinical Data Analysis & Reporting System (CDARS).
AVP and Delivery Head, TCS Life Sciences
Susan Korah, is AVP and Delivery Head with TCS Life Sciences unit. She has over 25 years of experience in various fields of Patient care viz. Pharmaceuticals, Healthcare and Medical Devices. She has experience in managing large and strategic accounts/projects with high financial values. She has also managed Integrated accounts with multi domains (CDM, Biostatistics and Programming, Drug Safety, Medical Devices and Medico - Regulatory affairs).
Prior to TCS, Susan was with Cognizant Technology Solutions (CTS) in their Life Sciences and Healthcare Divisions. Before CTS, Susan was with Novartis Healthcare Ltd., Hyderabad. She was one of the founder members in establishing their CDM business in India. Susan has also worked with other Pharmaceutical majors like Dr. Reddy’s Laboratories Ltd. and Merck India. She was into Clinical research and Medico- Regulatory functions in these companies.
Susan is a Post Graduate in Pharmacy with specialization in Pharmacology and Bio- pharmaceutics. She is a certified Six Sigma Black belt and LEAN Coach. She has her PG Diplomas in Clinical Research, Marketing Management and Business Analytics. She is also a practitioner of AGILE Framework. Susan had undertaken several Business transformation activities to drive and implement Cost optimization and Process Automations for the Biopharmaceutical Companies.
Jayathirtha Gopalakrishna, Ph. D.
Associate Vice President, Tata Consultancy Services
Dr. Jayathirtha comes with two-decade of Pharmaceutical/ Clinical Research experience. He worked in leading Pharmaceutical and Clinical Research organizations such as Sciformix, ICON, Ranbaxy and Quintiles across clinical R&D including Technology Organizations such as Oracle & Veeva, in sales/solution consulting. He is a recipient of India's premier national R&D (CSIR). Published several research papers in esteemed international and national scientific journals. He has delivered several sessions at various Pharmaceutical/Academic/Pharmacovigilance symposiums/ DIA, ISCR forums.
Global Programming Shared Services Head, IQVIA
Raghuram Thata has 20+ years of experience and specialized in setting up offshore Clinical Data Services Operations, he has worked across IT, BPO, Pharma, CRO industries and worked extensively with top Bio-Pharma Organizations. Presently he is the Global Programming Shared Services Head at IQVIA, prior to this, he has held leadership roles of increasing responsibilities at Novartis, TCS and Accenture. He is passionate about process reengineering, operational excellence, innovation, developing people, leaders. Raghuram’s qualifications are Bachelors in Statistics and Masters in Computer Applications.
Dr. Naveen K.K.
Executive Director & Head Centralized Medical Data Review & Analytics and Safety Solutions, Covance
Dr. Naveen K.K. is working as Executive Director & Global Head of Centralized Medical Data Review & Safety Solutions. In his role he is focused on establishing strategy & execution of Centralized Clinical Review methodologies using advanced technology & analytical approaches. Naveen KK has worked across India, China, Japan and US as operations head for multiple R&D functions like Centralized Monitoring, Medical Data Review, Pharmacovigilance and Connected Devices in CRO & ITES companies. Naveen KK has done his Bachelor’s of Medicine & Bachelor’s of Surgery and Masters in Business Administration specialized in Global Business Management and Information Systems.
Data Generation and Analysis, Bristol Myers Squibb
Jeanne Wu is the head of Clinical Trial Risk Management for Data Generation and Analysis at Bristol Myers Squibb. She has 20 years of experiences in the pharmaceutical industry, including leadership roles at Forest Labs, Sanofi, and Celgene/BMS. Her experiences include clinical trial risk management, statistical programming, database clinical programming, and CDSIC SDTM standards.
Jeanne is skilled at managing and strategizing resources, processes, systems, and standards. She is passionate about quality and takes pride in helping to develop and deliver medicines to patients. Jeanne has a M.S. degree in Statistics, and loves solving mysteries using data. She lives in New Jersey, United States, and enjoys traveling, meeting different people, and trying exotic foods.
Jonathan Andrus, M.S., CQA, CCDM
Chief Business Officer
As chief business officer, Jonathan Andrus leads Clinical Ink’s solution management and commercial teams to help sponsors and CROs better leverage eSource, eCOA, and ePRO data. With nearly 25 years of industry experience, Mr. Andrus brings extensive expertise developing eClinical services that integrate data and technology to help life science companies optimize study execution. At Clinical Ink, Mr. Andrus is responsible for P&L across Clinical Ink’s products and services, and he is also focused on building relationships and forging strategic partnerships with sponsors, CROs, regulatory bodies, and clinical research professionals.
Mr. Andrus joined Clinical Ink from Bioclinica where he led the eClinical Solutions Group to develop their current service offerings, including data management, quality management, implementation services, and IWRS. Prior to Bioclinica, Mr. Andrus worked in pharmaceutical consulting and with CROs focused on quality, data management, and validation. An active thought leader, blogger, and presenter, Jonathan served as chair of the Society for Clinical Data Management (SCDM) in 2008 and 2013 and currently serves as the society’s treasurer. He is also an active member of DIA (North American Advisory Council and Annual Conference Data/Data Standards Track Chair) and ASQ. He earned his bachelor’s and master’s degrees from Temple University’s College of Liberal Arts and Graduate School of Pharmacy and is a certified quality auditor (CQA) and certified clinical data manager (CCDM®).
Co-founder and CEO, CyteCare Hospitals
Ramu is a co-founder and CEO of CyteCare Hospitals, a comprehensive cancer care hospital
network. The first cancer 150-bed organ-site focussed cancer hospital that went live November
2016 on Airport Road, Yelahanka, Bangalore.
He is also a Co-founder of Cytespace Research, a clinical research solutions organization. Earlier,
Ramu was with Quintiles for about 10 years in various global business roles. Prior to joining
Quintiles in 2001, Ramu was a consultant for a PricewaterhouseCoopers. He was also an early
team member for a startup telemedicine company in India.
Ramu has a bachelor’s engineering degree from the Indian Institute of Technology in Madras,
and a Master’s in Business Administration from the Indian Institute of Management Calcutta.
Ramu is passionate about excellence in healthcare and research.
Executive Director, and Global Head of Clinical Data Management, Allergan
Sanjay is the Executive Director, and Global Head of Clinical Data Management at Allergan – an AbbVie Company where he is accountable for end-to-end delivery of CDM activities across all therapy areas. Previously, Sanjay held several strategic and operational roles in the industry with increasing responsibilities and scope at Merck/MSD, Novartis, and Biogen. More than 22 years in clinical data and technologies space, Sanjay is passionate about clinical research, organizational leadership, and building high-performing teams. He currently serves as the Vice-Chair of the Board at Society for Clinical Data Management (SCDM) and brings industry thought-leadership to the society through its Innovation committee and publications- most recently as the co-author of “Evolution of Clinical Data Management to Clinical Data Science” series of reflection papers. In Jan’2021, he will take on the role of Chair of the Board at SCDM. Based in New Jersey, Sanjay is a proud father of 2 high-schoolers.
Manager of Programming, Global Biostatistics & Programming, PPD – UK
Biplob is energetic & future focused industry leader with 13+ years of overall IT & CRO experience. He is currently working as Manager of Programming at PPD - Scotland, prior to this he has worked for PPD - India, IQVIA, PAREXEL & Cognizant when he was in India. He has extensive experience in CDISC standardization & Implementing automation process for Biopharma & Biotech clients across clinical Phase I-III studies for expediting submissions to regulatory authorities and intern improving patient health. He has proven track record in leading multiple high valued customers & larger teams to achieve profitable results consistently, ensuring repeat business from the existing customers and influence prospective customers. He is an expert global leader in building effective, committed and highly motivated teams for the organization, to manage dynamics within the customers effectively. Biplob has a bachelor’s engineering degree from the JNTU university. He likes travelling, reading books, cooking and devote time to family in his spare time.
Director, Medical Data Review, Head of Operations- India Centralized Monitoring FSP Services, IQVIA
Global Professional with proven leadership, technical and management experience across CDM &
RBM in a career spanning nearly 15+ years. Currently leading a team of 260+ team members across 160+ projects for the multiple FSP. accounts as an Operations Head in the RBM space.
Has been instrumental in setting up RBM process design/implementation for one of the largest
FSP account in the space of RBM. Has extensive experience in Customer Relationship, Operations Delivery, People Leadership, Process & Operations excellence in driving multiple Lean Six Sigma Projects through continuous process improvements & innovations
Co-Founder & CEO, NuvoteQ
Adriaan has almost 20 years experience in Enterprise Application Development and implementation including 7 years experience in Clinical Data Management and Drug Development digitization. He has led and managed many global and regional multinational projects and teams in various capacities.
Before taking a leadership position in nuvoteQ (a software company he co-founded) Adriaan worked at EOH Ltd (listed on Johannesburg Stock Exchange) as Divisional Head across various verticals, including Oracle Enterprise Application and Engineered Solutions. He recently founded a digital advertising agency as well an Oracle consulting firm, and currently serves on the board on a number of different technology and healthcare related companies.
Adriaan obtained his Bachelors degree in Information Technology, from University of Pretoria, South Africa. He then obtained his MBA from the UNISA Graduate School of Business Leadership in partnership with the Open University of Europe.
Sr. Director, Global Clinical Data Management and Central Monitoring, Bristol-Myers Squibb Company
Abhijit Parab, Sr. Director, Global Clinical Data Management and Central Monitoring heads up the clinical data management function within Bristol-Myers Squibb Company. In his role, he is responsible for providing strategic leadership to the data management team ensuring data integrity and completeness of the data used in clinical trials. Before joining BMS he lead the clinical data management team at Allergan plc (now AbbVie) playing a similar role and driving the governance and performance of clinical data management and statistical programming delivery partners. He is an active member of the TransCelerate and SCDM e-Source work stream representing Bristol-Myers Squibb Company and helping define the e-Source pathway in the organization. He lives in New Jersey, USA with his wife and 2 sons.
Pursuing Doctorate in Pharmacy (Pharm D) from Chitkara College of Pharmacy, Chitkara University
I, Nincy Philip, am currently pursuing my fifth academic year in the program, Doctorate in Pharmacy ( Pharm D) from Chitkara College of Pharmacy, Chitkara University.My aim is to contribute strongly to the healthcare sector demanding tact, enthusiasm work ethic, being part of a team encouraged and dedicated towards the betterment of the healthcare facilities.
I'm and have been a part of the Pharmacist student team visit as a part of the educational curriculum to attain knowledge and experience in the various sectors of hospital organisations, like Rajindra medical college and hospital, Fortis Hospital.
MBA (Pharmaceutical Management), NIPER Mohali
Gold Medal, Topper in B.Pharm (DPSRU, Govt. of NCT Delhi) 2015-2019.
Invited by Shri Anil Baijal (Lt. Governor, Delhi) and Smt. Mala Baijal at Raj Niwas to represent Pharma Graduates- 2020.
Awarded by Delhi Pharmacy Council for being Best Pharma Graduate - 2019.
Awarded by Honorable Deputy CM, Delhi for Academic Excellence- 2017.
NIPER Mohali Placement Coordinator- 2019-21.
General Secretary of DIPSAR/ DPSRU Govt. of NCT of Delhi- 2017-18.
Founder AREduX- 2020.
Head Biometrics and Medical Writing at Glenmark Pharmaceuticals Ltd
Sanjay Jankar is a Chemistry Graduate from Mumbai University, he has 20+ years of experience in the field of Clinical Data Management, Data Base Programming Biostatistics and Clinical SAS programming. Having started his career with Siro Clinpharm he has worked with Organization like GVK Biosciences, CLiniRx, bioRasi, Sunpharma and Glenmark. Currently he is General Manager & Head- Biometrics and Medical Writing at Glenmark.
Masters in Clinical Research (MSc), UPES, Dehra Dun
I am Vineeta Gowrisetty - at present a first year Master's programme student studying Clinical Research at University of Petroleum and Energy Studies, Dehradun. As a student of the healthcare industry, I am passionate about improving the quality of life of individuals.
Associate Director, Covance
Dr. Mallikarjun Koripadu, comes with a wide range of experience in various domains such as CROs, BPO/ITES (Supply Chain Management, Banking and Finance) in his 19 year’s career. He holds PhD in Engineering, SMP from IIM, PMP from PMI, CCDM certification, Certified Lean Six Sigma Master Black Belt, Certified in Business Analytics. He has published 8 white papers in various National and International Journals, presented in many conferences and also chaired a few sessions. He is a life member of Indian Institute of Engineers, International Association of Engineers, Quality Circle Forum of India and contributes to these institutes. He also has one Patent for the tool he created on ‘5D problem solving methodology’. Mallik is currently engaged with Covance, as an Associate Director, Program Management.
Masters in Health Economics (MSc), Manipal Academy of Higher Education
Chetna is graduate in Pharma from Jamia Hamdard University, New Delhi, and currently in the second year of my master's pursuing an MSc. Health Economics from Manipal Academy of Higher Education, Manipal University, Karnataka. I am certified in Advanced Excel and R language and working on various curriculum projects as a team leader including Systematic Review. I am interested in taking health care decision modeling as my future career.
Associate Manager (Sr. Statistician), Accenture
Ritu Karwal is working as Associate Manager (Sr. Statistician) with Accenture. She is a statistician by qualification and experience. She has wide experience of nearly14 years in working for CROs and pharma companies.
Usha Rani A
Lead Data Manager, Cytespace Research Pvt Ltd
Usha Rani A, Lead Data Manager at Cytespace Research Pvt Ltd with close to 9 years of Global experience within the CRO/Medical Devices environment. Have worked closely with sponsor on site (US) and attended sponsor audits. Along with the Core Data management experience also a Certified Rave Database builder.
Previously worked at IQVIA as Associate Data Team Lead.
Key experiences are within the therapeutic areas such as Cardiology, Dermatology, Oncology, Pulmonology and Gastroenterology.
Continuous learner at work and looking forward to acquiring many more learning experiences from Scientific & Academic Institution body such as SCDM.
Usha Rani A holds a Master’s degree in Biochemistry and a Bachelor’s degree in Microbiology.
Covance, Senior Manager CDM
Clinical research professional with over 14 yrs of experience in CDM, and certified clinical Data manger. With expertise of handling trials across multiple therapeutic areas and phases. Actively involved in activities like project management, planning process stream lining and successful execution of projects.
Shobha holds a bachelor degree in dental surgery and PG Diploma in Clinical research and data management. Currently associated with Covance as Senior Manager CDM.
Global Head of Clinical Data Management, Novartis
Jagadeesh is currently serving as Global Head of Clinical Data Management in Novartis, has over 20 years of experience in the industry. He brings in a wealth of experience cutting across multiple business functions within clinical development and in his previous experience he has played senior leadership roles with increasing responsibilities primarily in Data Management but has significant experience in leading teams across Risk Based Monitoring, Centralized Monitoring, Data Analytics, Biostatistics, Statistical Programming and Medical/Regulatory writing over the last several years. He also comes with a strong Operational Excellence experience championing several OpEx projects delivering significant business value. During his previous roles, he has considerable experience in managing large global teams across multiple geographies. As part of his overseas experience in EU for couple of years, he has also managed customer relationship portfolio delivering value to the bio-pharma customers in the past. As a Global leader, he provides thought leadership across the clinical research domain and engages actively with Biopharma world.
Sr. Manager Clinical Operations, ICON
Ahmed Shujauddin, Sr. Manager Clinical Operations, ICON, playing the role of country manager for project monitoring for India, Singapore, Malaysia & Bangladesh. He is in industry from 17 years and covered different facets of clinical research including clinical monitoring, Project Management, Operations Management, People Management, Study Start-up & Regulatory. He was responsible for start-up and regulatory in his previous role and played vital role in setting up local and regional strategies to improve speed and effectiveness of the processes. He was instrumental in overseeing some of the largest and longest studies recruiting more than 1000 patients in India and has provided guidance and leadership to many studies.
Manager, Clinical Data Management, PRA Health Sciences
Poulamee has 13 years of experience in Clinical Data Management industry and has worked across different therapeutic area and technology platforms. She has managed CDM teams for all phases including early development and late phase. She has led key innovation projects with main focus on people and technology. She is currently working as a Manager, Clinical Data Management at PRA Health Science. Prior to joining PRA, Poulamee has held numerous positions across CRO, BPO and Pharmaceutical industries. She has also been a speaker at global SCDM annual conferences. When not at work, Poulamee enjoys travelling and spending time with her 2 year old kid.
Senior Clinical Data Analyst, Parexel International
Kartik Ahuja has a vast experience in the clinical trial domain with a combination of more than 13 years in the clinical data management and clinical coding. Kartik understands the various stages of the clinical data management and with coding information to support him on the various task. The author has good interdisciplinary interaction skills as well which helps in a complete all-round understanding of his discipline.
Ganesh Kini Chandrakanth
General Manager, Accenture
Ganesh Kini Chandrakanth is a Service Delivery Lead in Accenture Applied Life Sciences Solutions. He is a Biotechnologist by training and a seasoned Six Sigma Black Belt professional with 20+ years of experience in Pharmaceutical, Life Sciences, Pharmacovigilance and Clinical Data Management Operations. Ganesh comes with significant experience in the Pharmaceutical R&D Industry and possesses end to end knowledge of Clinical Trial Lifecycle, Pharmacovigilance and Regulatory processes. He has proven ability to set up and manage large, complex teams; has led various continuous improvement initiatives, contributed to change management activities and multiple employee engagement initiatives. Currently Ganesh has moved to Large Global Biopharmaceutical client as a Service Delivery Lead managing Database Development, Custom Functions, CTSS, eTMF, Build Testing, EmBARC, CRS, & CDRA.
Director, Statistical Programming, Parexel
Lakshmikanthan Santhanakumar is a Director, Statistical Programming at Parexel International, heading Statistical Programming team in India. In his current role he is responsible for strategizing India operations and ensuring timeliness and quality deliverable. He provides expertise and consultation, facilitate metrics collection and develop action plans. He has been with Parexel for about 8 years managing Database Programming, SDTM and Statistical Programming teams. He has been in the industry for the last 17 years with experience working in Data Management, Database Programming, SDTM and Statistical Programming in various Therapeutic areas. He has done his M.Sc., from Bharathidasan University. Before joining Parexel, he worked for organizations like Accenture, Clinsys and Take Solutions.
General Manager, Accenture
Akshaya Kamath is Operations Manager and SME for Clinical Data Management. Responsible for Delivery of Study Data Tabulation Model (SDTM) for a large US Life Sciences client with overall 13+ years of experience in Accenture Applied Life Sciences Solutions R&D Practice based out of Bangalore. Have a Bachelors of Science degree in Computer Science and Statistics. Currently, leading a large SDTM team and managing delivery.
Product & Outreach Manager, Uppsala Monitoring Centre
Damon Fahimi is working as a Product and Outreach Manager for WHODrug at the Uppsala Monitoring Centre (UMC), the maintenance organisation for WHODrug Global. Damon holds a MSc Pharm degree from Uppsala University, Sweden. He joined the UMC in 2012 and is responsible for making sure that WHODrug Global meets regulatory and user needs.
Ali A Hoque
Engagement Delivery Lead, Cognizant
Ali is an M.Phil in Microbiology with 14 years of domain experience. Working as Engagement Delivery Lead; responsible for CDMP, CTMS, Medical Coding and Regulatory submission deliverables. As Clinical domain is undergoing transformation, he is keen in learning new tools and technologies and collaborate with Clients in planning and implementation of such initiatives.
Shunmuga Priya Sj
Clinical Data Management Associate, Accenture
Shunmuga Priya SJ is Clinical data management associate for Clinical operations in Accenture. She has an overall experience of 3+ years in Clinical data management. She holds a B.Tech Biotechnology degree.
Principal Statistical Programmer, Icon Docs
Sandhya Yalla has Over 10 years’ above experience as Statistical Programmer and delivering high Quality Analysis and Reporting on Clinical Trials data using SAS Technologies in CRO’s and BPO, Pharma industries.
Currently performing the role as 'Lead Programmer' for Ophthalmology TA in ICON Docs.
Worked as a Trial Programmer for multiple studies.
Further, Served the role of a Programming Team Lead (PTL) for few studies which involved managing the overall study conduct with Quality, interaction with client, report reviews, resource allocation, conducting internal team meetings, targeting milestones for the Dry run1,2, DSMB, Top-Line and Final Analysis and all statistical deliverables and productivity in relation to budgets.
Faced diligently few External Audits, which helped me to gain knowledge and Monitored the tracking documentation, Followed SOPs\ Guidelines and ICH-GCP.
VP and Global Head of DM, Quanticate
Deepu has around 16 years’ experience in Clinical Data Management, has expertise in end to end data management processes across paper and electronic data capture (EDC) studies and across all phases of clinical trials in multiple therapeutic areas. Has worked for major CROs in the past on top 10 pharma accounts in various technical and leadership roles handling team sizes from 50 to 200. Currently heading the Data Management Global Operations at Quanticate as Vice President and Global Head. He has been part of the India SCDM Steering Committee for the last 2 years and has been Co-Chair for SCDM Single Day Events (SDE) in India and also was the Co-Chair of the First Virtual SCDM SDE India in June 2020.
University of Texas Health Science Center, Houston
Kalyani Sonawane, PhD is an Assistant Professor in the Department of Management, Policy and Community Health, and an affiliated member of the Center for Health Care Data, University of Texas Health Science Center at Houston. Her expertise is in performing population health analytics using high dimensional healthcare data to inform clinical practice and policy. Dr. Sonawane has conducted several real-world studies using health insurance claims, nationwide surveys, electronic medical records, and patient registries to study prevention and treatment strategies and to evaluate their downstream impact on population health outcomes. She has experience working in multiple disease areas including infectious diseases and chronic conditions including hypertension, diabetes, stroke, chronic kidney disease, oncology, irritable bowel diseases, multiple sclerosis, psoriasis, and rheumatoid arthritis.
Dr. Sonawane has published in prestigious clinical journals including the Lancet Public Health, Annals of Internal Medicine, JAMA Pediatrics, JAMA Network Open, and Journal of the National Cancer Institutes. Her research has been featured in media outlets including CNN, TIME, Forbes, NPR News, NBC News, and CNBC. Her work has been funded by the National Institutes of Health, Centers for Medicare and Medicaid Services, Texas Department of Health and Human Services, and Florida Department of Health.
Senior Manager, IQVIA
Mahesh Kumar is a postgraduate in life sciences by training. Working in clinical research industry for more than 15 years. Currently working as Senior Manager, Medical Data Review-Centralized Monitoring Services in IQVIA. I have been part of core clinical monitoring, project management, data management and presently part of centralized monitoring for 8 years. Passionate about operational excellence and innovation. Proud about the fact that I’m contributing towards betterment of patient’s treatment and experience.
Senior Principal RWE Data Scientist, Novartis
Abheenava Kumar is working as Senior Principal RWE Scientific Data Analyst at Novartis Healthcare Pvt. Ltd., Hyderabad. He has 12+ years of experience in Clinical safety reporting, Pharma analytics related to HCP, Brands performance, patients analytics etc. He holds master degree in Biochemistry and diploma in Bioinformatics from IBAB, Bangalore.
RWE Scientific Data Analyst, Novartis
SaiPoojitha Gudiboina Graduated with Bachelors of Technology from Computer Science and Engg. I have been working in Healthcare Industry since 2+ years and am well versed with RWE related information, with experience in working Market Access, Feasibility and Protocol studies. I am working on DASH from past 6 months
Medical Services Specialist, Accenture
Sneha Kothuri is a Certified Clinical Data Manager with a decade of Data Management experience. She has worked with IQVIA, Parexel and is currently working at Accenture as Project Manager. She has extensive experience in end-to-end study activities for Oncology, Rheumatology & Endocrinology trials. With master’s in chemistry, Post Graduate Diploma in Clinical Research & bachelor’s in biotechnology, Sneha likes to keep herself constantly updated with latest technologies.
Sneha believes in being future ready. Passionate about the evolution of data sciences, gleaming insights from data and spending time with her one-year old son. Sneha is currently trying to help communities cope with Covid pandemic. She firmly believes that together all of us can come out stronger and post-Covid economic development will be rapid.
Vice President DCT Innovation, Medable
Rasmus Hogreffe, MSc.Med., MBA is considered as a Virtual Clinical Trials expert. His main goal is to improve treatment for patients by making trials better and faster than ever before, using digital and remote innovations.
He holds an Executive MBA and a Master in Medical Science (MSc. Medicine) and has, since 2010, been working in the healthcare industry in various positions within clinical research & development.
Rasmus has extensive experience in the pharmaceutical industry and has been involved in more than 60 clinical trials, giving him a broad knowledge regarding every aspect of clinical research.
Furthermore, Rasmus is a serial entrepreneur and has a successful record of starting and selling companies within his broad scope of interests: Digitalization of clinical trials, Patient recruitment, Real World Data, and Health innovation.
In addition, as an external lecturer and supervisor at Aalborg University, Rasmus has developed and given courses and workshops on management of clinical studies on topics such as the development of recruitment and retention strategies, site-optimization, site-selection and patient engagement to sponsors, investigators and study teams at leading medical centers.
His innovative approach within the field of digital health, Patient Recruitment, and Virtual Clinical Trials make him a frequently used chairman and speaker.
Sheeba Manoj Nair
Sheeba Manoj Nair is the Quality Assurance Lead for Accenture Applied Life Sciences Solutions (ALSS). She is responsible for the QA Management including developing and managing quality programs to promote and monitor the quality and performance of Accenture operations as they relate to clinical services and overall compliance with Accenture and Customer procedures and policies as well as with regulatory requirements.
Sheeba has an overall 17 years of experience in CRO industry and clinical research domain. She holds a PhD degree.
Protocol Data Manager, Clinical Data Management, Accenture
Amit Patil - Protocol Data Manager, Clinical Data Management, with a Master’s Degree in Clinical Research. Responsible for end-to-end Clinical Data Management activities with overall 10+ years of experience in CDM. Currently working for Accenture Applied Life Sciences Solutions based out of Hyderabad, Managing Studies as Project Manager in CDM.
Software Development Analyst, Iqvia
Chiranjib is having 9+ years of IT experience with specialization in building IIoT solutions from the ground-up and deploying them to on-premise platforms. Contributed actively in designing, developing and executing in-house projects on user dashboards along with advanced data analytics to create interactive experiences for business users. He has contributed extensively towards the use of statistical and machine learning models in the energy domain under Industry 4.0 initiatives.
Associate Manager, Accenture
Vinod Kumar is working with Accenture as a Automation Lead for over 10 years now. I have been supporting on automations, AI, ML and Analytics for various Life Sciences Client.
Executive Vice President, The Emmes Company, LLC
Dr. Robert Lindblad is currently an Executive Vice President for the Emmes Company, LLC. He was the former Chief Medical Officer at Emmes for 19 years. Prior to joining Emmes, he served as a medical officer at the US Food and Drug Agency (FDA) where he worked on regulating biologic products. His medical practice was in Emergency Medicine for over 30 years. While at Emmes he has run large networks for the National Institutes of Health (NIH) where multiple efforts have focused on utilizing electronic health records and institutional data bases to conduct research or augment data collection in clinical trials. Issues surrounding what questions can be asked and answered, data standardization and quality, consent and permission to access data have been central themes.
Associate Director, Cytespace Research Private Limited
Asha Nair has 21 years of experience in the field of Medical Research, She currently manages Clinical Trial conduct across 50+ Hospitals throughout the country and is the Head of Operations at Cytespace Research Private Limited which she joined in 2011.
Asha has worked with Multi-specialty Government Hospitals like Govt. Medical College & Hospital, Trivandrum as well as private institutions like Amrita Institute of Medial Sciences and Lakeshore hospital, Cochin. Here she contributed in varied clinical research studies including International Clinical Epidemiology Network and phased trials across multiple therapeutic areas.
She has engaged with all the stake-holders touching the clinical data at the site, including the Investigators, Monitors, Auditors and Ethics Committees. Asha actively supports hospitals to constitute their Ethics Committee, create SOPs and conducts training to the Investigators and Ethics Committees. She has facilitated 50+ Ethics Committees across India to get registered with the CDSCO.
Asha is most passionate about working at the site, specially trial naïve sites and Investigators in order to make them “Clinical Trial Ready” by providing training, resources, processes and technology.
Head of eClinical Technologies, Global Data Management and Standards, Merck & Co.
Rakesh is a transformative clinical and health data sciences pioneer with 25 years of experience in the Industry. He is a SCDM eSource Implementation Consortium Co-Chair/Co-founder and TransCelerate eSource Initiative Co-Lead. At Merck, he is the Head of eClinical Technologies, GDMS in the Global Clinical Trial Operations function. His broad range of responsibilities includes strategic evaluation, drive improvements of current technology landscape, enablement and adoption at scale of innovative solutions such as eSource, Digital Health Technology and Decentralized Clinical Trials Technologies in conjunction with data strategy, standards & processes.
Rakesh was formerly at Novartis, where he held various roles, including Global Head of Business Technology services in the Clinical Technology and Innovations function. His area of responsibilities included technology optimization, enablement and adoption of new technologies & provide other value added services. He lead/supported various innovative initiatives such as eSource, ePRO/eCOA, eConsent, Decentralized Clinical Trials. Prior to that, he was the Global Head of Clinical Database Delivery & standards in the Clinical Data Operations at Novartis.
Rakesh is an author of several scientific publications, and a frequent speaker at industry conferences and symposiums. Rakesh holds MS in Biomedical Engineering from USA and has completed MIT Sloan Executive Education Program in Artificial Intelligence: Implication for Business Strategy.
Director, Data Operations Technical Service, Syneoshealth
Dharmaraj Ramji is a seasoned professional with over 16 years of Technical and Management experience in Data Management and Statistical programming. He is currently working as Director, Data Operations Technical Services at Syneos Health. In the current role, he is responsible for leading and managing Clinical programming team. During his years of tenure at ICON, PAREXEL and Agati Systems, he had worked on various facets of Clinical Data Service - Data Management, Database Designing, Data validation/processing, Database Programming, SDTM conversion, Statistical Programming and Clinical Review. Primarily his skillset evolves around managing bigger projects across portfolios and people across all the technologies/tools.
Program Manager, Cognizant
Worked for pharmaceutical, biotechnology and medical devices clients. Brings extensive experience in technology planning, implementation, business IT alignment, technology portfolio assessment across clinical development areas.
Program management/ Stakeholder & 2PL management to tracking the progress of program office & identification of program risks.
Designed & conceptualized solutions, Implementations, Integrations and migrations for
EDC (Oracle InForm & OC/RDC, Medidata Rave).
LifeScience Data Hub and DMW.
Standard macros for Define XML, P21 validation.
Expertise in designing Integrations such as Query Management System, SAE recon, Protocol. Deviation management systems with various EDC and its data warehouses.
Experience in GxP validation activities for the products developed in Clinical Space and experience in Product migration activities.
Experience in setting up studies for a large Bio Pharma and Pharma and worked on more than 100 studies.
Expertise in reports development using PL/SQL and Cognos.
Extensive knowledge of the CDISC-SDTMIG, CDASH standards and the current trends in the industry and unique combination of experience of working with market leaders.
Srinivasa Subramani (Mani)
Vice President, Accenture Pharmaceutical Services
Mani is Accenture Operations Clinical Capability Lead in India.
Overall 20 years of industry experience, of which the last 16 years, Mani is involved in setting up large operations, transitioning complex processes, driving innovations, managing large client accounts in Accenture Applied Life Sciences Solutions.
Mani has Master’s degree in Science from Bangalore University and is based out of Bangalore.
Lead Business Technology Manager (Senior Manager) – Technology & Application Management, Data Science & Analytics division, Bayer Pharmaceuticals
Mayur Challawar works as Lead Business Technology Manager (Senior Manager) – Technology & Application Management, Data Science & Analytics division at Bayer Pharmaceuticals, Hyderabad. He has an overall experience of 12 years in business technology engagements, and has exposure to projects across cloud implementations, IT Strategy, business process transformation, solutioning.., across domains – Pharma, Banking, Retail & Compliance. On the education front, Mayur holds a Post Graduate Diploma in mgmt. from T A PAI Management Institute, Manipal, and prior to this he did BE in Mechanical Engineering from Osmania University – Hyderabad. Prior to working for Bayer, Mayur worked at Arcesium (a D E Shaw & Co), Infosys Consulting.
Manager with the Early Phase development services, PPD Bangalore
I am Payal, working as Manager with the Early Phase development services in PPD Bangalore. I have close to 15 years of experience in Clinical research industry and hold a CCDM from SCDM. I am keenly observant of the new methods, industry standards and technological advancements in the clinical trial industry and this drives an interest in me to attend the SCDM conferences every year. This conference is indeed remarkable, as it gives us an opportunity to interact digitally in this New Normal so looking forward to share some insights on the topic “Technology & Big Data Impacting Clinical Development During New Normal”. Please
Senior Director, Clinical Programming & Data Management, Covance
Having worked for 20+ years within the different areas of clinical data flow ranging from Data Acquisition, Standards, Statistical Analysis and Submission at various levels across Programming & Management roles.
Prior joining Covance, worked for GSK, Quintiles, Octagon and Accenture
Trained ~250+ professionals in CDISC - SDTM
Senior Project Manager, CDM, Quanticate
Balaji Rajanna is currently working as Senior project manager at Quanticate. He has more than 13 years of experience in Clinical Data Management from study start-up to database lock.
He has extensively supported SDTM studies & CDASH setup of various studies for more than a decade.
He has extensive experience in therapeutic areas like Rheumatology, Ophthalmology, Neurology, cardiovascular, Oncology, musculoskeletal and Endocrinology and different phases of study from Phase I to Phase III.
V Narasimha Rao Rayaprolu
Principal Clinical Programmer Novartis Healthcare Pvt. Ltd
Narasimha is working as Principal Clinical Programmer at Novartis Healthcare Pvt. Ltd., Hyderabad. I have 10+ years of experience on Analytical & Reporting tools and at present working on Tibco Spotfire as a lead developer to build dashboards using Clinical and Operational data. I main responsibility is to create reports which lets clinical teams to review a clinical trial life cycle which are in conduct phase giving highest precedence to patient safety.
A technologist at heart, Raghu has over 15+ years of experience in applying high quality technology solutions in to meet the BioPharm needs and opportunities.
He is a strong believer in continuous learning. During his recent education at Indian School of Busines, Hyderabad’s 18-month Machine Learning Program, he realized the powerful role AI and Data Science can play in aiding the clinical trial experts to design and conduct patient centric trials. This propelled him to turn into an entrepreneur and he founded TrierHealth to pioneer AI Driven Clinical.
Before turning into a passionate entrepreneur, he has 20+ years of global experience across US, India and UK. His experience includes
• VP of Software Engineering for ESW capital
• Head of India technology team for Parexel
• Lead Program Manager with GE Healthcare
He has an MBA from Warwick Business School - UK, Master of Science from University of Wisconsin US and a Bachelors of Engineering in Computer Science from NIT Rourkela
Associate Director-Clinical Data Management at Novartis
Shariff is working as an Associate Director-Clinical Data Management at Novartis. He looks look after Hematology and Cardio Renal Metabolism portfolios. He has 15 years of experience in Clinical Data Management industry with exposure towards Process Improvement, Project Management, Operations Management and People Management. He has worked on DCT, Operational excellence projects and many HA submission critical projects. In his current role, he is responsible for strategizing, ensuring timeliness and quality deliverable. When away from work he likes playing outdoor sports and spend time with my family.
Senior Director, Data Management, IQVIA
Medical Biochemist with 22 years of experience across basic research, academics and clinical research industry.
He heads the India DM Operations team and has extensive experience in leading DM team serving large, medium, small pharma and biotech companies across different engagement models like FSP, Full Service and Standalone DM services.
He has been instrumental in setting up teams for niche services, driving innovations, developing and enhancing skillsets of data managers.
He is passionate about driving operational excellence through use of new and emerging technologies.
V Arockiaraj Praveen
Associate Director – Global Project Management, Covance
V Arockiaraj Praveen is currently an Associate Director – Global Project Management with Covance and manages a team of 300+ associates within the Lab Project Management vertical. His team works on building a LIMS system and also supports clinical site setup through closure for every clinical trial for over 12000+ projects every year. Praveen has about 16 years of industry experience in varying business verticals including Clinical Data Management, Regulatory Document Review Management and Process Excellence. He has presented in several India and global SCDM conferences prior to this session on Clinical Labs.
Principal Clinical Database Developer, Novartis
Vijayroshan M is working as Principal Clinical Database Developer at Novartis with over 12 years of clinical industry experience. Have worked on multiple EDC platforms like Oc, Rave and Inform. An enthusiast of automation, have successfully developed multiple automation projects to ease daily mundane work of data management using the principles of heuristics. From the recent past I have been studying on the subjects of AI and ML that have a huge potential to make our existing systems achieve greater efficiencies.