Leadership Forum

The Leadership Forum will take place on Sunday, September 11 from 9:00 AM to 4:00 PM, during the SCDM 2022 Annual Conference.

This is an exclusive event for industry leaders and an additional attendance fee of $500 applies. If you would like to participate and have not received a personal invitation, please click on one of the buttons below and follow the registration process to submit your application.

leaders

Over the last decade, the evolution of clinical research practices and supporting regulations, as well as massive advances in technology, have fundamentally changed the nature of clinical research data.  Therefore, data management strategies must evolve in a manner consistent with these changes and in particular, reflect the risks, complexity, and value of the data collected. The Clinical Data Management discipline is morphing into Clinical Data Science.

The 2022 SCDM Leadership Forum will provide industry and regulatory leaders with opportunities for in depth discussions of the issues associated with this evolution, in particular as they relate to process, technology, people and regulatory considerations.

Over the course of the forum, we will go on a highly interactive journey covering four topics:

I. Technology

Technology is changing our clinical data industry and the data industry is changing the technology requirements.
Rapid digital transformation, including robotic process automation, machine learning (ML) outlier detection, smart query tools and central ingestion of high volume/high complexity data streams (e.g. real world data (RWD), decentralized clinical trial (DCT) data) is not just a theory anymore but roadmaps are built to drive short and long term business value.

Moderator

Richard Young, Vice President, Vault CDMS Strategy, Veeva Systems

Moderator

Patrick Nadolny, Global Head, Clinical Data Management, Clinical Sciences & Operations, Sanofi

II. People

Developing and attracting talent in an employee driven market to facilitate the evolution to Clinical Data Science.

Over the past year, we have seen a dramatic increase in hiring at Pharmaceutical and CROs, as well as other technology companies across the globe. This has created an increased demand for talent and an employee driven market, resulting in large increases in salaries and a lowering of expectations from higher levels.  In this session we will discuss the impact of working from home, increased demand, counter offers, and the erosion of internal equity on the labor market and employee retention.  We will discuss what we can do as an industry to improve and how we can continue to expect more from our associates as we evolve Clinical Data Science in this environment.

Moderator

Stephen Cameron, Associate Director, Clinical Data Management, ICON

III. Processes

Adapting processes at the same pace as technology changes.
Recent progresses in the technologies available to support clinical research offer important opportunities to transform our processes to focus on the quality of critical data, process more data faster, make clinical trials more accessible to patients and sites, and improve our cycle times. 

Moderator

Catherine Célingant, Executive Director, Data Monitoring Management, Pfizer

IV. Regulatory

Current regulatory thinking about technology and process changes impacting Clinical Data Science.

In an ever-changing clinical and data landscape, it is equally important to understand how the regulatory landscape is changing in tandem.

This session will be an opportunity for us to enter in a dialogue with regulators on topics such as draft guidances, DCTs and discuss how the regulatory landscape is changing.

Moderator

Eboni Russell, Senior Director, Clinical Data Management & Head of FSP DM Services North America, Labcorp

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