There are many factors involved in selecting the best Electronic Data Capture (EDC) platform for a clinical study and program. This webinar will demonstrate how selecting the right EDC can help ensure project success and return on investment.
Having the right EDC platform in place helps to ensure project efficiency from the start. The goal of an EDC system is to support the unique requirements of its users and enable them to efficiently perform the functions and tasks required for successful project delivery. However, in order to get to that point the right process should be followed. It’s worth the time and energy it will take upfront to research the capabilities the EDC will need to perform because it takes in excess of 80 hours to get trained, per user, on most systems, and six months to a year to gain full proficiency.
Attendees who participate in this Webinar will learn how to:
- Identify high-level system and end-user requirements
- Evaluate vendors and systems
- Eliminate systems that failed to meet high level requirements and re-evaluate the remaining systems
- Develop a vendor audit questionnaire that can be sent to the EDC platforms selected for the short list
- Identify detailed functional and user requirements
- Compare each EDC system against the requirements that it needs
- Rank the systems based on how well your requirements are met, putting more weight on more important factors
- Complete a detailed company stability assessment of the final chosen vendors
Commitment and investment are correlated; the costs associated with changing systems can be substantial, so the long term financial return must be evaluated. It is important to make sure research is done thoroughly on the front end, and return on investment (ROI) has been weighed carefully.
This model can be applied to any clinical data system that requires detailed evaluation. Examples and figures will be provided.
Toby Odenheim, MBA, Director, Clinical Technology Services, SynteractHCR, United States
Toby Odenheim is the director of Clinical Technology Services at SynteractHCR, where he oversees clinical technology initiatives and service offerings. Toby has been with SynteractHCR since 2005 and has over 15 years of industry experience, including a strong emphasis on systems selection, implementation, and validation. Prior to joining SynteractHCR, Toby was the cofounder and technical director for ClinicalSoft, LLC. He holds an MBA, a bachelors in biology, and is a certified Oracle DBA.
Cathi Sciacca, Executive Director, Global Clinical Operations, Intercept Pharmaceuticals, Inc.
Cathi Sciacca is the Executive Director, Global Clinical Operations at Intercept Pharmaceuticals, Inc. heading the Clinical Operations Department and its management team in its international Phase III trial in Primary Biliary Cirrhosis (PBC), and in the oversight of other ongoing and planned clinical trials. Cathi’s experience spans over 18 years in the bio-Pharmaceutical and CRO industries, including project management in clinical and preclinical/new product development.
Who Should Attend?
- Managers and Executives involved with Clinical System selection
- Clinical Data Management and Clinical Systems managers work directly with EDC systems during the course of a study program
In 2013, San Diego-based Synteract acquired Munich-based Harrison Clinical Research – and expanded its services and strength to the Power of Two – two excellent CROs that, together, provide global, full-service clinical trial services. SynteractHCR (http://www.synteracthcr.com/) is a full-service, international, contract research organization with a successful two-decade track record supporting biotechnology, medical device and Pharmaceutical companies in all phases of clinical development. With its “Shared Work – Shared Vision” philosophy SynteractHCR provides customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster.
Operating in 16 countries, SynteractHCR delivers trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.