Single Day Event - DELHI

Society for Clinical Data Management (SCDM) > Single Day Event – DELHI

Theme: Importance of Clinical Data Standards & Analytics in Era of Digitalization

Clinical trials are becoming more and more complex. In this era, how standards and analytics can play an important role in optimizing business outcomes.

During our previous SDEs in 2018, we focused on how technology is changing the CDM landscape. The next step going forward is to talk about how standards are evolving in the age of digitalization. A standards-driven approach to clinical development enables more rapid study start-up and optimal data capture, facilitating the consolidation and aggregation of patient-centric datasets, interpretation, and integration. We will cover aspects of automation as to how repetitive tasks can be standardized plus exploring methods to efficiently process collection, management, and collaboration with clinical data. The other aspect of discussion also would be to explore and better understand the usage of MEDDRA and WHODD coding dictionaries.

Technology is evolving every day, leading the change to a new way of living. It helps us survive longer than we used to and to explore our world in more depth.

Through automation, technology is rapidly changing the way things are done across many industries. In terms of the healthcare industry, technology giants such as Amazon, Google or Apple are trying to approach this industry differently. For instance, Amazon is building its own electronic health record, Google is taking efforts on DNA sequencing, and Apple is turning its iPhone into a diagnostic data hub. These are only a few examples of all the new changes the healthcare sector is currently experiencing. Furthermore, IT companies are increasingly investing in the industry and accelerating their efforts to improve it by introducing new sensors, apps, and many other advanced tools.

Standards and its implementation with strong governance fundamental to the clinical trial process with CDISC providing the perfect framework for this metadata. In terms of the healthcare industry, HL7 standards and in terms of clinical trial CDISC standards trying to approach this industry to bring in multiple benefits. Thus, Metadata management and managing medical dictionaries across domains CDM and PV are becoming more effective. However, the session will be focused to explain and discuss live scenarios on standards management and of how Points to Considers & Standardized MedDRA queries are implemented and also understand WHODD to implement Standardized drug groups.

This conference will explore ideas and case studies to answer the below challenges in today’s CDM world and will look at harnessing new technologies to improve metadata management and terminology management

All this raises a major question: How to redefine the future of Clinical Standards & Terminology Management?

This conference will explore ideas and case studies to answer the below challenges in today’s CDM world and will look at harnessing standards to improve medical coding efficiency.


Mapple Emerald, NH8, Yawantika Colony, Rajokri, New Delhi, 110038





Avinash Kumar (Bio)
Senior Director, Statistical Programming
Syneos Health

Challenges And e-Opportunities in Clinical Data Management

An engineer by qualification, Avinash is currently working at Syneos Health as Senior Director (Statistical Programming). He has 19 years of professional experience in the role of Relationship & Delivery Management with various IT & CRO companies. Apart from managing large teams at the offshore Delivery Centre in India, Avinash also spent 3 years at client sites in USA. His core competency lies in Pharma/Healthcare, a domain where he has been extensively involved with ‘Clinical Statistical Analysis using SAS’. Avinash has also significant experience working on various BI & data warehousing tools like ’SAS BI’ and ‘Ab Initio’.

Sarvesh Singh
Vice President – Data Management group
ICON Clinical Research

The Digital Wave – How It Impacts Data Management

Sarvesh Singh is Vice President for the Data Management group in ICON Clinical Research. In his current role, he has oversight for the APAC DM team spread across India, China, and Japan. He is also on the PhUSE Board of Directors representing APAC. As APAC Regional Director of PhUSE, his primary responsibility is to deliver high-quality events to advance PhUSE’s learning and network opportunities for APAC Data Scientists. He organizes PhUSE events in India, China, and Japan every year. He has also been on the scientific committee and judging panel of CONSPIC organized by IASCT (Indian Association of Statistics in Clinical Trials) for two years in 2015, 2016. He is also on SCDM India Steering Committee and has been Chair for SCDM Single Day Event as well as Session Chair in SCDM India Annual Conference. He has presented in several national and international conferences as a speaker as well as a panelist. Apart from working in India he has also lived and worked in USA and Netherlands for close to 5 years. He completed his MBA from Rotterdam School of Management (Netherlands) and an M.Sc. in Statistics from the University of Delhi. He has decades of experience in the clinical industry across all phases of clinical trials managing Biometrics (Data Management, Clinical Programming, and Biostatistics).


Deven Kishor Babre 
Director Clinical Data Management 

Deven has been in the industry for more than twenty years, with over eighteen years of experience in Clinical Data Management, Pharmacovigilance, and Pharmaceutical industry. He has sixteen years of experience in project management, resource planning and creating training plans for new/existing employees. Proficiency in Web-based technologies, information dissemination and numerous databases and in Data and Safety Management Systems such as Oracle Clinical (Certified from CSS), Inform (Certified from Phase Forward), Medidata Rave, ARGUS, WebSys and Client Developed Systems. Prior to Cognizant, he was working as Associate Vice President at Tata Consultancy Services, Clinical Data Management.

Inderbir Singh 
Senior Director – Clinical Data Management, Biometrics
Syneos Health

Inderbir Singh serves as Sr Director for Clinical Data Management, Biometrics at Syneos Health. Inderbir Singh has been a Clinical Data Management professional for more than 16 years. Inderbir has worked in Pharma, ITES and CRO organizations over these years. Inderbir has been associated with SCDM for the past 10 years whereas he was the Lead Reviewer for the Database Closure chapter of GCDMP in 2009, he was part of the Global Task Force for CCDM Certification in 2010 and he was also part of India Task Force in 2014.

Sujith Kurup
Director, Software Development

Sujith Kurup serves as Director for Software Development at IQVIA. He has over 15 years’ experience in the health and life sciences industry and was previously associated with companies like Accenture, UnitedHealth Group, ICON Clinical Research, and Bioclinica. A seasoned professional who has worked on all facets of Data management with a particular interest in programming and analytics. He is a Medidata certified train the trainer and a certified study administrator and programmer on RAVE. He is also a certified project management professional from PMI. He also serves in the global committee on SCDM membership and a member of the India SCDM steering committee.




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