Director – Global Project Management, Bangalore
Praveen is a Senior Leader with a proven track record of leading multifunctional teams internationally in the CRO and healthcare industries for the past 18 years. As a solutions partner, he works with internal stakeholders at all levels in a multinational organization in identifying and executing improvement opportunities.
In his current role he is the Director and Head of Global Project management team in India. In this role, he holds responsibility of managing a team of 400 individuals who work on tasks leading to site initiation, sample management, creation of investigator manuals, alerts management, lab programming outputs and kit production.
Praveen has presented in India and global conferences over the past 11 years as a speaker, chair and a debate panelist.
Debu Moni Baruah
Debu Moni Baruah's background spans the fields of clinical data management, research, marketing, and data analytics. Debu has supported CROs, technology companies, and sponsor organizations where he has ideated novel clinical data management and analytics concepts and led several key innovation projects with a major focus on the areas of people, process, and technology, which were critical for the success of his employer and clients. He has set up processes, authored SOPs, WIs, published over 40 articles, and presented in several international and national conferences. Debu is currently supporting the editorial board of JSCDM, academic committee, innovation committee - SCDM, and the development of GCDMP chapters. Debu has acted as session chair, organizer-speaker in webinars and conferences, facilitated workshops and presented posters in SCDM, DIA, and several prestigious bodies of academia. Academia has honored Debu with a title for his contributions. He is a Registered Product Owner™ and lean six sigma black belt. Currently, Debu is providing leadership to a data analytics team at GSK as an associate director.
Dr. Santosh Karthikeyan Viswanathan
Dr. Santosh Karthikeyan Viswanathan is a Certified Data Management Professional working as Associate Director, Clinical Programming at AstraZeneca. He is involved in providing strategic, technical, and operational leadership for Data and Analytics platform in R&D. He has led data science project on predicting adverse drug reactions in Life Sciences and managed teams in digital and analytics practice. He completed his Ph.D. in Management Studies from St. Peter’s Institute of Higher Education and Research. He holds Master’s degree in IT, Business Administration and Psychology. He has also completed Advanced Post Graduate Diploma in Clinical Research and Data Management. His research papers are published in various National and International journals. He has also participated in National and International conferences. His areas of specialization are Data Analytics, Data Science and AI, Cloud Computing, Change Management and Psychology. He is an active member of SCDM and SCDM India Membership Committee.
Syneos Health's Director of Clinical Data Management, Garun Yadav, leads Syneos Health’s data management team to help sponsors build and conduct their clinical trials faster. With over 16 years of experience, he brings extensive knowledge of data management solutions. During his career, he held various roles including start-up data manager, lead data manager, InForm SME and Oncology SMEs. His functional focus included Protocol Review, Study Start-Up, External Data Handling, Data Validation, Clinical Programming, Analysis and Reporting. His therapeutic expertise includes Oncology, Autoimmune, and Neuroscience. He has been leading FSP 360 teams since 2016 and continues to provide leadership. His other work experiences include Kendle Data and Technologies, TATA Consultancy Services, and SIRO Clinpharm. Garun earned his Bachelor of Science degree in Microbiology from Mumbai University and his MBA in Healthcare Administration degree from Sikkim-Manipal University.
Senior Director (India CDI Lead), Clinical Data & Insights (CDI), AstraZeneca
Ram Mudaliar is currently working as Senior Director (India CDI Lead), Clinical Data & Insights (CDI) at AstraZeneca in India. In this role, he is accountable for establishing and expanding the CDI footprint in India, liaising with CDI Global Leaders & local leaders to develop and implement strategic decisions for the India site. Prior coming to India, he was in Canada and played different roles such as Interim Global Head of Oncology in Data Management, then responsible for Lung portfolio delivery, line managing Data Managers based out of North America (US & Canada) and working as Canada DM Site Lead. Prior, moving to Canada, he was also working in Poland hub managing both Warsaw (Poland) and Budapest (Hungary) locations where he led the expansion of Oncology Data Management team set-up and developed highly efficient data experts.
Ram is passionate about creating a highly efficient teams who can work collaboratively with a strong speak up culture, a strong zeal to work towards organization’s vision and goals and with a mindset of continuous upscaling of skillsets to meet the demands of current and future business needs.
Dr. Sheeba Manoj Nair, PhD
Associate Vice-President- Quality Governance Organisation
Sheeba has about 18 years of experience in pharmaceutical organizations and in Clinical Research. The research exposure includes different area of research aspects of drug bringing to market globally including clinical trials in patients and healthy population and the post marketing surveillance of the medicinal product. Expertise includes inspection readiness and assessing regulatory requirements of medicinal development and hosting Regulatory Inspections.
Sheeba been part of multiple CROs during her tenure, Lamba Therapeutic Research, Cliantha , IQVIA and associated with Accenture since Last 4 years
In the current role Sheeba leads the QA team for the QMS implementation globally including the client audit and regulatory inspection management for the life science division. She has a PhD degree as qualification and published research papers and presented in conferences.
Abhishek Ghosh has 19 years of CRO experience. Currently he is working as Executive Director - Clinical Development at Premier Research Bangalore India. Been part of start-up to scale up journey at business unit level, lead implementation of new outsourcing functions to it’s scale up and securing contract renewal. He has worked as an expat in China for couple of years for setting up CDM function for an international CRO. Out of India delivery center he has executed various roles such as Head of Delivery Centre; Head of client delivery for multiple portfolios (FSP, Non-FSP) and performed Operations Management, Project Management and People Management cross-functionally in RBQM, Centralised Monitoring and Clinical Data Management. He leads myself and his team members with wellbeing and with a sense of purpose for translating organization’s vision into reality. He holds a Masters Degree in Pharmacy, PMP and is pursuing his Doctoral studies in Behavioural Sciences.
Accenture Solutions Pvt. Ltd.
Manikanthachar SN, works with Accenture and leads data management team to build and conduct the clinical trials faster for Sponsors. With over 13 years of experience, he brings extensive knowledge of end-to-end clinical data management solutions and very good knowledge of all the leading EDC platforms. During his career, he held various roles including lead data manager and study start up SME. His functional expertise includes Protocol and Study Design Review, Study Start-Up, External Data Handling, Medical Coding and Data Validation. His therapeutic expertise includes Oncology, Endocrinology, Autoimmune, Neuroscience and Vaccine. His other work experiences include Quintiles, Kendle Data and Technologies and Parexel. Manikanthachar earned his Bachelor of Pharmacy degree from Rajiv Gandhi University of Health Sciences, Bengaluru and his Master of Pharmacy in Pharmacy Practice from National Institute of Pharmaceutical Education and Research – Hajipur.
Agatha Christina Moses
Agatha Christina Moses has over 18 years of IT and pharmaceutical industry experience. Her experience spans Clinical database programming, Computer system validation, Clinical reporting and data analytics, and R&D Application Maintenance. She works as a Program Lead, Central Services at Pfizer. She leads a multifunction portfolio that embraces Reporting and Data Analytics, User Acceptance Testing, Medical Technology, and Business operations. She oversees the delivery and operations of the portfolio. She drives continuous process improvement and innovation by connecting clinical trial processes and technology to improve quality and efficiency. She has led and contributed to numerous global initiatives. She holds a Master of Technology degree in Computer Science. She is an active member SCDM India Membership Committee.
Ankita works as a Clinical data manager in Accenture with 9 years of industry experience. Ankita has worked in all phases of clinical trials from DM perspective, she is the key contributor since the inception of trial till the Database Lock. Her job involves forecasting and foreseeing the right challenges, DM resources for trial, setting up of databases along with data cleaning and database locks. She is an active member of DM journey where she contributes to mindset change for Data Managers, training new associates, as well as looks for new possibilities in technology to improve the Data Management services
Bibin Jacob Raju
Syneos Health - India
Master of Science – Bioinformatics
Bibin is a Clinical research professional with 15+ years of experience in Clinical Data Management which includes diverse experience in managing RBM, Product Development , Programming and Coding group
He has extensive experience in setting up offshore operational unit for both CROs and Sponsors with leading experience in managing group of highly experienced CDM professionals across globe.
He has supported organizations in implementing new CDM technologies and adopting technological advancement in the fields of Data operations.
He is passionate about driving scientific understanding in Clinical Data Management fraternity and has proven track record of driving operational excellence across large multi geographical CDM groups.
Commenced his CDM journey in 2010 as a college freshman. Had an intense 12 plus years of hands-on experience in CDM in various reputed organisations in versatile roles contributing in end-to-end CDM activities from Set-up, Conduct and close-out. Through-out my career I have worked in processes which gives DM end to end studies. Have worked in various therapeutic areas like Oncology, Cardiometabolic, Renal, Metabolism, Auto-immune diseases etc. Passionate about data management and learning all the technical aspects associated with it. Aim to use my versatile experience which I have learned to deliver solutions to make Data Management more robust. Love Cricket, Music, Cooking and Eating.
I have Post Graduated in MSc Biotechnology with vast and varied experience in CDM for 16 plus years. Have worked in different TA's, mainly being Oncology, Endocrinology, Neuroscience, Cardiovascular, Immunology and Virology, have experience working with various platforms used in industry and on different phases of clinical trials. Liable to various cultural diversity by working with different organization. Recognized with several awards in different companies for good project management skills for end-to-end activities in CDM. I am inquisitive learner and always keen to explore more in CDM and apply my learning skillsets in different tasks. My preferred pass time being travelling and binge watching.
Soumya Veerla is a Senior Manager, Data Management at ICON.plc. Soumya has been in the CDM space for 15 + years . She has been with ICON.plc for more than 8 years at various leadership roles managing large & small pharma portfolios along with driving various initiatives. Soumya is involved in an ongoing initiative of evaluating & implementing Artificial Intelligence & Machine Learning in clinical data review at ICON. She is passionately proactive, displays agility & always been solution focused . She is always happy to invest time in coaching and mentoring her team. She always takes up challenging responsibilities & takes great pride in her work. In her free time she likes to explore canvas painting and practices mindfulness.
Somu Piraman, has 20+ years of background in IT technologies, but has been concentrating on the Life Science Industry for the last 11 years in delivery and consulting roles. His primary focus in recent years is to Implement RBQM functionality for customers as part of the Thoughtsphere Product suite. He brings in rich product building technical experience and functional operational process experience in RBQM. This unique mix of knowledge and his passion towards customers makes him successful in his role as a Product Implementation leader. He is here to share his learning and challenges faced by Industry in embracing RBQM.
Dr. Jean Mulinde
Associate Dir. for Clinical Policy, Div. of Clinical Compliance Evaluation, OSI at Food & Drug Administration
Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in CDER’s Office of New Drugs. She received her M.D. and completed a residency in Internal Medicine at the University of South Alabama School of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine. Before joining the FDA, she served as Assistant Professor of Medicine in the Division of Infectious Diseases, Program of Traumatology, at the University of Maryland’s R. Adams Cowley Shock Trauma Center
Accenture Solutions Pvt. Ltd.
A total of more than 18 years of experience in various roles; Clinical Data Management, Operations Management, Program and Project Management, along with Process Excellence & Innovation in Clinical Data Management. Currently working as Quality and Compliance Manager in Accenture Solutions Pvt Ltd.
A successful track record managing small and large groups of working professionals, including hiring, training, and management of resources. An expert in Clinical R&D projects for pharmaceuticals contributing to the improvement of processes and applications, an experience of developing and delivering training and create content for clinical trials.
Contributor to SCDM- GCDMP chapter writing group and have published three EDC chapters on EDC system selection, Study startup, Study conduct and closure; Currently working on another chapter on CDM Metrics. Certified ISO/IEC 27001:2013 Information Security Management Systems Lead Auditor. Associate capability lead, responsible to build teams that spans across the Therapeutic Areas through Center of Excellence.
CDM professional with 17 yrs of core DM experience. Majority work experience is concentrated in Oncology domain. I have worked for Pfizer, Syneos, ICON and now working with Caidya. The exposure at largest to mid-size companies has led me to develop an approach of look for simple, logical and replicable solutions via Operational excellence through available options and tools such as optimization, innovation or Automation. In my personal time I explore ancient Temples to study architecture and history or volunteer at Girl’s orphanage Divyaprabha or Cancer shelter run for patients from rural India treated at Tata Memorial Hospital, Mumbai.
Raghuram Thata has over 24+ years of experience across IT, BPO, Pharma and CRO industries and specializes in setting up Clinical Data Sciences business from scratch| has built large teams to support DM Programming, Statistical Programming, Data Management, Statistics, Medical Writing and Regulatory submissions – using technologies such as all leading EDC, SAS, Python, Spotfire, C#, Tableau, BI| turned around engagements that have deteriorating relationship| provides solutions for large, complex opportunities, builds BPaaS services |develops AI/ML/RPA, analytics to reduce cycle time, improve yield and quality | has expertise in Operations, transitions, transformations, Organization effectiveness |is passionate about giving back to community, Raghu supports people from economically weaker sections, speaks at SCDM, PHUSE and ISCR |Raghu is currently Sr. Director, Global Head of Programming @ IQVIA and has teams across 7 countries| Raghu is Bachelors in Statistics from Bangalore University and Masters in Computer Applications from Bharathidasan University.
Arshad Mohammed is the Head of Global Data Management at GSK. He is a physician by training and brings over 20 years’ experience in the health sciences industry. Prior to the current role, Arshad has held a variety of roles in life sciences consulting, software product management, clinical data management, business development and electronic clinical outcomes assessments (eCOA). He has managed clinical data management teams across all phases of clinical development including early development, late phase as well as studies in the observational space. He is a Board of Trustee of the ‘Society for Clinical Data Management’. Arshad is an alumnus of Armed Forces Medical College, Pune and Indian Institute of Management, Ahmedabad.
Aparajeeta has 16 years’ experience working in healthcare, clinical and life science industry. She has held various roles in sponsors and CRO organizations prior to joining Medidata. Aparajeeta has Master of Science Biotechnology from (DBT, India) and Data analytics certification from NUS Singapore. She has over 13 years of clinical trial experience with sponsors and CRO. In her current role in Medidata she provides consulting service to sponsors and partners on eClinical technology solutions.
Dr. Abhishek Kadam
Abhishek Kadam has overall 15.8 years of industry experience. Abhishek has done his graduation in Homoeopathy from Mumbai University followed by PG Diploma in clinical research from ACE, in Bombay College of Pharmacy. He has completed Executive Program in Leadership and Management from IIM-C and Post Graduate Program in AI and ML from Great Lakes and University of Texas, Austin, Texas. Currently pursuing Master of Data Science from Deakin University Australia.
Abhishek has worked on multiple therapeutic areas including Respiratory, Cardiovascular, I&D and CNS. In the past, he has handled roles of increasing responsibility in clinical data management and been an operations manager for deliverable from study set-up to CSR publishing.
After joining Novartis in 2018, Abhishek has pursued his area of interest which is automation and application of DS AI&ML to DM. He leads a team of data scientists which provides data driven solutions for business problems in clinical data management. He is a business solution lead for first in the industry tool that creates machine readable specs for Clinical Trial Database development, which has now catered to more than 100 studies inhouse.
Before pursuing a career in clinical research, Abhishek had a private homeopathy clinic for 4 years. In his spare time Abhishek likes to read management books. Abhishek is married to Shruti and has two daughters Chinmayee and Mruunmayi and they all live in Mumbai currently. Abhishek likes to read and spend time with family at his vacation home near Mumbai.
Premier Research, India
Bhavesh has 25+ years of experience in Clinical Research across Clinical Operations, Clinical Data Management / Biostatistics, and Clinical Trial Sites in India and China.
He has held various leadership roles across CRO Industry and currently leading a team of Clinical Development Services professionals in Bangalore and Clinical Trial Sites in 20+ cities across India. He is passionate about bringing patient-centric technologies to improve patients' participation in clinical trials and to better engage patients for improved clinical trials outcome.
By education, he is a Pharmacist, and he is trained in the various programs at IIM Ahmedabad (India) and Forum Corporation (USA) on building Strategies, Leadership, and Coaching. He is a global speaker and presented and participated in various conferences in India and abroad at SCDM, PHUSE, DIA, ISCR, China Clinical Trials.
Navitas Data Sciences
Shrishaila has done Masters in Biotechnology from Bangalore University & have more than 18 years of experience across Biometrics (which includes CRF Design, DB Setup, SDTM, ADaM & TLF creation etc).
He is currently working as Senior Vice President at Navitas Data Sciences, heading the Statistical Programming department, India.
In his volunteer work, he is currently supporting as “PHUSE India Events officer” & responsible for leading all the PHUSE Single Day Events (SDE’s) in India. He is also a "CDISC Volunteer” & involved in development of CDISC standards.
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.
Clinosol Research Private Limited.
Apoorva has completed her Bachelor’s in Dental Sciences from Kamineni Institute of Dental Sciences with 71.1%. She has published a blog on “Investigator Responsibilities.” She has presented a topic on “Causality Assessment in Pharmacovigilance” She has attended multiple national and international conferences/workshops during her academics and her tenure with ClinoSol as a student. She has completed various online courses on clinical research, pharmacovigilance, clinical data management. Apoorva is currently pursuing Advanced Certification Program in Clinical Research and Clinical Data Management from ClinoSol Research Private Limited.
K. Revathi Yadav
Clinosol Research Private Limited.
Revathi has completed her Master’s in Engineering in Bio-technology stream from Birla Institute of Technology and Sciences (Hyderabad) with a CGPA of 6.9 and has completed her Bachelor’s in Engineering from Satyabhama Institute of Science and Technology, Chennai with a CGPA of 8.49
Her laboratory skills include Primer designing, PCR, GEL Electrophoresis, Molecular Cloning,Western blotting, DNA/ RNA extraction, Mammalian cell culture, Flouroscence Microscopy.
Her computer proficiency includes C Programming, Python, Microsoft Office.
She also possesses basic knowledge on bioinformatic tools and statistical analysis
She has completed an intensive course on Clinical Microbiology from Azyme Biosciences Pvt. Ltd. (2018) and Quality Control training from Rainbow Pharma Training Lab (2017)
She has completed certifications on Bioenergitics of Life Process and Cell Culture Technologies from NPTEL, Next Generation Sequencing from Biogrademy, and Introduction to Data science from Course Era
She has published two papers; one in Research Journal of Pharmacy (June 2021) and the other in Asian Journal of Pharmaceutics (March 2020)
She holds a patent for Method of biofertilizer production for enhancement of growth, nitrogen fixation, nutrient uptake & yield in leguminous & non-Leguminous Plants. (Filing date : Jun 20, 2021, | Issue date : Mar 16, 2022, | Patent No : 2021103486 | Patent office : Australia)
She has participated in multiple competitions and conferences/workshops during her academics.
She is currently pursuing Advanced Certification Program in Clinical Research and Clinical Data Management from ClinoSol Research Private Limited.
Novartis Healthcare India Pvt. Ltd.
Shreyans has overall 12.5 years of Industry experience. He has done his M.Pharm. in Pharmacology from Nirma University, Ahmedabad. Shreyans has primarily worked on Oncology and Rare Disease therapeutic area. He has handled roles of increasing responsibility in clinical data management and been an operational manager for deliverables from study set-up to Database locks. He has been associated with multiple process improvement, automation initiatives and implementation of Data Science to clinical data management (CDM). He is currently the lead business SME for first in the industry tool that creates machine-readable specs for EDC development, and for DM Data Science team. Before joining CDM, Shreyans has worked as TMF associate for 6 months duration. Shreyans is married to Binita and has 3.5 years of old daughter, Kavya. He is fond of spending time with Kavya and friends after office hours and exploring new learnings.
Priyanka Pradeep Pandhare
My name is Priyanka Pradeep Pandhare. I am born and brought up in Mumbai and currently settled in Chennai.
I have completed my Masters in Clinical Research with Diploma in Clinical Research Management.
I completed 12 years in this industry in Aug-22 and working with ICON Clinical Research Organization for last 5 years.
I am currently working in ICON as Clinical Data Management Group Lead.
Dr. Lisbeth Bregnhoj
Medicines Inspector (GCP), at the Danish Medicine Agency
Lisbeth has been a GCP and pharmacovigilance inspector at the Danish Health and Medicines Authority
Since 2006. Prior to that, she has experience from the authority perspective on regulatory affairs and authorization of clinical trial protocols (1993-1999), from a research and hospital perspective (Clinical pharmacology at a University Hospital in Denmark 1999-2005) and from working in the medicinal industry (GCP auditor 2005-2006).
Lisbeth has performed numerous GCP (and PhV) inspections, both national inspections on behalf of the Danish Health and Medicines Authority and international inspections on behalf of the European Medicines Agency in various settings such as sponsor sites, CRO sites and investigator sites.
Lisbeth is part of the GCP Inspectors Working Group and of the sub group, authoring the European Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials.
Management professional 15+ years of experience in Healthcare/Pharmaceutical, Risk Based Monitoring & Clinical Data Management. Leading Data Management team in ICON Clinical Research India Pvt ltd performing Data cleaning and Centralized Monitoring activities across various Therapeutic areas for multiple customer accounts. Demonstrated track record of delivery of data management and centralized monitoring services to various Global Pharmaceuticals Organizations. Responsible for mobilizing the Clinical Delivery model (Data scientist role) a global strategic Data Management initiative to evolve Data management to Data science role. Actively assess and help manage project realization. Ensure project milestones are met according to agreed-upon timelines with high quality and optimal profitability. Actively involved in performing market risk analysis and developing mitigation steps.
Licenses & certifications: “Data Scientist Foundation Certification” IABAC™ - International Association of Business Analytics Certifications.
Specialties: Portfolio & Delivery management, RBM process design and Implementation, Hiring and Talent Management, Mentoring, Quality Management and Team Building, Metrics and KPIs review | Process Innovations/Improvements.
A talented and effective communicator, with an energetic approach to work. Overall service experience around 19 years in Healthcare and Clinical Data Management. Currently working with Pfizer India as an Associate Director (Asset Lead) and contributing towards life saving pathways across globe. A fun filled team player, leader with Proactive approach, result oriented, promotes and follows empathy, ready to face challenges and explore new adventures. Always strive to do something better than yesterday and carrying positive atttitude. An Avid writer of poems and blogs / write ups, who loves making friends, collaborating, networking and facing life with grace, Joy, gratitude and Smile.”
Pratap Kumar Namburu
Pratap Kumar Namburu working as Senior Principal Statistical Programmer at Parexel, Hyderabad. He has done his Post graduation in Masters of Computer Applications from Acharya Nagarjuna University. He is having overall 15 years’ experience in technologies like SAS, Python and domain knowledge in clinical, Finance, banking and retail with multiple global companies. During his tenure he has worked on various standard macro programs, narrative automation, and tool development that enhances the quality and reducing rework.
His hobbies are watching cricket , cooking and listening to music.
Johnson & Johnson
Nikita Agnihotri is Strategy, Sourcing & Process Head, Clinical & Statistical Programming at Johnson & Johnson Pharma. Prior to joining J&J, Nikita led pharma accounts for IQVIA and TCS as well as led Biometric functions at Sanofi and Novartis. She has supported several clinical studies and led various global strategic projects and initiatives.
Nikita holds a Master’s degree in Mathematics specialization in Statistics and Operations Research from Indian Institute of Technology, Bombay, India.
Dr Deepak Kallubundi
Senior Director (Head of Clinical Data Management Operations) FSPx, Labcorp Drug Development
Dr Deepak brings in over 18+ years of experience in industry with high expertise for Project’s, Program’s and Portfolio’s handling for various FSP’s and Stand-alone services. In his current role is responsible for Governance of FSPs, building technology alliances and Operational Delivery at Global Level. He is a Certified Clinical Data Manager and Certified Process Manager. He has participated in various SCDM, ISCR, Phuse and DIA conferences as speaker, Session Chair, Co-chair and currently heading as Chair for SCDM certification committee.
Johnson & Johnson
Sreesha Nair presently holds the position of Director, Data Management Head India at Johnson & Johnson. She has over 17 years of experience in Clinical Data Management and has played multiple leadership roles. She has led and implemented strategic, people and technical initiatives in her previous endeavors. She’s passionate about learning the science behind drug discovery and people development.
She has done her master’s in microbiology and is a certified scrum master. She has also earned a certification in Cancer Genomics and Precision Oncology from Harvard Medical School online learning.
Dr. Anitha Kumari A.
A visionary leader who drives a culture of organization-wide excellence through motivation, empowerment, and personal example. Holds a rare combination of skills and knowledge: A medical professional with Six sigma. Project management, in-depth experience in the clinical research field, and exceptional people skills to manage diverse global teams. Currently holds the position of Global head of Operations for Novartis.
Priya 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. Priya is passionate about coaching and writing.
Praveen Dass is the Global Head of CTO providing Clinical Trial Management, Data Management, Biostatistics, Statistical Programming, and Regulatory Medical Writing support for Medical Affairs and Country organizations in Novartis.
Prior to Novartis, Praveen has held various leadership roles in service delivery for Pharma at organizations such as Accenture, Tata Consultancy Services, ICON Clinical Research and Quanticate over the last 20 years.
Praveen has also been a member of the SCDM India Steering Committee over the last few years and has had the privilege of serving as the SteerCo Chair in past.
Sachin Tonapi is the Executive Director, Global Head Data Operation, CDM at Labcorp leading the teams in India, USA and Latin America.
He has 20 years of industry experience across Pharma, BPO and CRO. He has experience in leading large global teams, setting up and leading FSP partnerships. His responsibilities have spanned several levels of management as well as long term strategic initiatives.
He is a Certified Clinical Data Manager (CCDM) from Society for Clinical Data Management (SCDM) and a Certified Six Sigma Green Belt.
Sachin has presented at various global and Indian conferences including at SCDM, DIA, ISCR.
Dr. Appalla VenkataPrabhakar
Has working experience of more than 25 years in Pharmaceutical & CRO Industry.
Statistician by training with double Masters & PhD in Statistics from School of Sciences, Gujarat University.
Did undergo middle management development program at IIM-A & did attend leadership workshop at IIM-B.
Has extensive experience in Operations Delivery, Project & Program Oversight, Customer Relationship Management & Line Management, Coaching & Mentoring.
Has published around 16 papers in various National & International Journals of which 5 were published in Data Basics Magazine of SCDM.
Has been speaker at various conferences both at National & International forums.
Has been active member of SCDM & has been part of conferences in various capacity.
Inderbir Singh has been serving in the industry across various spaces such as Clinical Data Management, Clinical Programming, and Statistical Programming over close to 19 years. Inderbir is a postgraduate in the Computer Science and a Lean Six Sigma Green Belt from the University of North Carolina. Inderbir has been associated with SCDM since past 12 years and supported in various roles. Inderbir is currently working as Executive Director, Biometrics with Syneos Health and is responsible for teams across India and Europe, in the past he has worked with various prestigious organizations from Pharma, ITES and CRO such as Ranbaxy, HCL Technologies, inVentiv (Now Syneos) and INC (Now Syneos).
C. S. Mujeebuddin
Mujeeb is an M. Pharm and M. Sc (Clinical Research) from Manipal University.
He has worked in the clinical research industry extensively since 2006 and has held various positions in some of the top-most Pharma CRO and Pharma-IT organizations (QPS, Parexel, Accenture, Oracle, IQVIA).
Has started his own organization, ClinoSol Research Pvt. Ltd. to pursue his passion for teaching and has been training the young minds in different vertices of clinical research industry as skilled professionals (1000+ student placements since 2019)
His action-based visions and directions have helped ClinoSol grow over the last three plus years to an extent where hundreds of students from Medical, Dental, Pharmaceutical, Life Sciences, and Bio-Medical Engineering are able to learn and find a more suitable career.
Has been taking active part in Industry Conferences as an Academia Partner since 2020 (ISCR and SCDM). Has bagged several appreciations and awards such as;
CoVID Warrior Award by Indian Pharmaceutical Association (2020 &2021) | Academic Excellence Award by InSc (2021) | Best Clinical Research Training Organization by Hon’ble Home Minister of Telangana, Shri. Mahamood Ali (May 2022) | Best Clinical Research Training and Placement Award by National Integrated Medical Association (NIMA in September 2022)
Suhas Kirani Ravindra
Suhas Kirani Ravindra is a strategic leader part of Technical Excellence & Innovation within R&D Biostatistics. He has 15 years of experience in the pharma industry and extensive knowledge of clinical trial reporting across multiple phases and disease areas, as a SAS programmer he has provided programming leadership globally at different level of drug development and since 4 years following his passion towards innovation he is building a team of R & SAS Developers, Data Scientists, Clinical Analysis Standard Experts, providing strategic direction to enterprise programs & products, and changing the current landscape by challenging the status quo to simplify, harmonize and automate Biostatistics tools and process to enable acceleration of end to end clinical development. He strongly believes in SAFe agile framework and continuous learning culture.
My objective is to enhance the data processing capabilities in the field of Clinical Data Management by bringing in automation for complex and time-consuming activities.
To add simplicity to how Data can be visualized and understood. Also, I believe Data Managers should feel empowered to handle complex clinical trial data by getting insights of the data on time.
I am, currently working on creating value adding insights of clinical/vendor data which would help in pro-active risk management, ensure control over the data.
The clinical data management team should be able to plan different strategies using real-time data insights and trends through value addition from CDS.
Accenture Life Sciences R&D Operations
Shobhit Shrotriya is an experienced professional in Accenture’s Life Sciences R&D practice based out of Bangalore. He is an Engineer by training with a Masters in Industrial Management from Indian Institute of Technology (IIT) Kanpur. He is a Certified Six Sigma Black Belt and Project Management Professional (PMP).
With 21+ years of work-experience, Shobhit has extensive experience in Operations Management, Project & Program Management, Process Excellence and Innovation. Shobhit is a Subject Matter Expert who contributes to the solution development, process re-engineering, and implementation of life sciences outsourcing service delivery. With extensive experience in life sciences operations, he has managed end to end global projects and large customer accounts with an excellent track record of delivering mega-scale projects on time, under budget and with high standards of quality. Shobhit has a passion for talent and leadership development, driving employee engagement and retention while guiding teams to deliver on both strategic and operational objectives.
Shobhit has been associated with leading industry forums such as Project Management Institute (PMI), Drug Information Association (DIA) and Society for Clinical Data Management (SCDM) over the years where he has contributed both as a presenter and a session chair.
In his current role as Accenture Global Lead for Life Sciences R&D Operations, Shobhit is responsible for providing comprehensive domain expertise and driving standardization of processes and best practices across client teams.
Bhaskar Subramanian is heading the Statistical Programming @ Labcorp. Overall, he has 22+ years of experience in the Clinical Industry ranging from Data Management, clinical trial reporting and Regulatory operations across multiple phases and disease areas. He is passionate about innovation, process optimization, developing enterprise solutions and building new talent capabilities. His focus is always on being customer centric and following agile principles. Prior joining Labcorp (Theorem/Chiltern/Covance), worked for GSK, Quintiles, and Accenture(Octagon). Bhaskar lives in Bangalore and enjoys playing badminton.
Dr. Madhu Kumar. R
Mysore Medical College & Research Institute
MBBS from JSS Medical College, Mysore. Gold medalist in Pharmacology
MD- General Medicine from Father Muller Medical College, Mangalore.
DNB - General Medicine from National Board of Examinations, New Delhi
12 years of Clinical experience post MD.
Current Designation - Assistant Professor in the Department of General Medicine in Mysore Medical College & Research Institute (MMCRI), Mysore.
Served as chief COVID coordinator at MMCRI in organising & conducting the screening, testing, and management of COVID-19 patients during the pandemic.
Was the chief coordinator for initiation of COVID-19 vaccination program in MMCRI.
Keen Interest in academic and Clinical research with 6 plus years of experience in clinical trials.
Participated in Global and national clinical trials including phase II,III,IV studies as Co Investigator & Principal Investigator. Worked as a co-investigator in PLACID - plasma therapy trial in COVID-19 sponsored by ICMR. Conducted clinical trials in Diabetes, Asthma , Mild to moderate Covid 19, ARDS in Covid 19 , Snakebite, Vaccination, Oncology, Dysphagia, & so on.
Asha Nair currently serving as Director, Site Solutions in Premier Research, has over 23 years of experience in the Clinical- Medical Research Industry.
She currently heads the team involved in Clinical Trials conducted in 50+ Hospitals across the country.
In her previous experience, Asha has played a vital role in providing expertise in varied clinical research studies including International Clinical Epidemiology Network and phased trials across multiple therapeutic areas. She has worked in Multi-specialty Government Hospitals like Govt. Medical College & Hospital, Trivandrum. And private institutions like Amrita Institute of Medical Sciences and Lakeshore hospital, Cochin
Asha comes with strong Clinical research Domain expertise and is an SME in supporting hospitals to constitute their Ethics Committee. She also has created and continues to support the creation of many Standard Operating Procedures for Hospitals in this domain.
She has been involved in providing the best in the industry training for the Investigators and Ethic Committees. She has a proven record of facilitating 50+ Ethics Committees across India which has resulted in getting registration approval from CDSCO to date.
Asha brings a wealth of experience cutting across multiple business functions within the Clinical site solutions and has been passionately involved in working with sites, especially trial naïve sites and Investigators to prepare them “Clinical Trial Ready” by providing the finest in industry training, resources, processes, and technology.
President & COO at Crio & Treasurer and Past Chair of SCDM
As President and COO,Jonathan leads CRIO’s customer experience and quality management teams. With 25+ years of experience, Jonathan brings extensive expertise developing eClinical services that integrate data and technology to help life science companies optimize study execution.
Prior to CRIO, Jonathan served in numerous roles at Clinical Ink, including leading sales, solution management, operations and data management to help sponsors and CROs better leverage eSource, eCOA and ePRO data.
Jonathan 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 IRT. Prior to BioClinica, Jonathan worked in pharmaceutical consulting and with CROs focused on quality, data management and validation.
An active thought leader, blogger and presenter, Jonathan has served as chair of the Society for Clinical Data Management (SCDM) in 2008 and 2013 and currently serves as the society’s Treasurer. Jonathan is an active member of DIA (Program Committee), Decentralized Trials Research Alliance (DTRA), eCOA Consortium and ASQ. Jonathan earned his bachelor’s and master’s degrees from Temple University’s College of Liberal Arts and Graduate School of Pharmacy and Jonathan is a Certified Quality Auditor (CQA) and Certified Clinical Data Manager (CCDM®).