Mid-Study Changes: Keeping Your Clinical Trial on Track with EDC

Life Sciences, Clinical Trials, Medical Device, Medical Device Clinical Trials,
  • Thursday, February 23, 2017

Many clinical trials require at least one amendment — and often several changes during the course of the trial, and those changes typically impact the technology used to collect the data. There are many factors involved with the development, approval and implementation of mid-study changes. Therefore, it is important for the electronic data capture (EDC) technology used in the trial to efficiently support the development, testing and rollout of amendments in order to streamline the process and to avoid creating a bottleneck around the deployment of changes.

Having an efficient EDC development environment in which to design the necessary mid-study changes, (together with a robust, in-situ deployment capability), can help roll out necessary changes to the appropriate sites as soon as possible. With more and more clinical trials utilizing adaptive designs, EDC capabilities are increasing in importance.

Join the webinar to learn how technological advances are helping to best support the mid-study change process.


Rich Davies, Executive Director of Business Solutions, OmniComm Systems

Richard Davies joined OmniComm in February 2014 and is based in the UK. As Executive Director of Business Solutions his role is to support organizations’ adopting OmniComm solutions from a technical, functional and business process perspective, particularly as they execute their vendor selection programs. Additionally he has product management responsibilities and provides a bridge between customers, prospects and ongoing product development.

Mr. Davies joined OmniComm from Oracle/Phase Forward, where he held multiple roles in the sales and implementation of many types of e-clinical, drug safety, warehousing and healthcare technologies. He has worked for technology vendors for nearly 20 years but prior to this, he worked in data management with Fisons Pharmaceuticals and Astra. Mr. Davies earned his Bachelor of Science degree in Computer Science from DeMontfort University in the UK.

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Who Should Attend?

  • Heads of Clinical Data Management
  • Heads of Clinical Innovation
  • Heads of Clinical IT
  • Heads of Clinical Operations
  • Heads of Clinical Research
  • Heads of Clinical Systems
  • Heads of Medical Affairs

Xtalks Partner


OmniComm Systems is a leading strategic software solutions provider to the life sciences industry. OmniComm Systems is dedicated to helping the world’s pharmaceutical, biotechnology, CROs, research and medical device organizations maximize the value of their clinical research investments. Through the use of innovative and progressive technologies these organization drive efficiency in clinical development, better manage their risks, ensure regulatory compliance and manage their clinical operations performance. OmniComm provides comprehensive eClincal solutions from Phase I through late phase clinical trials with an extensive experience with over 4,000 clinical trials.

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