Electronic Data Capture (EDC) Capabilities
EDC Vendor Experience:
I have worked for several EDC vendors to provide both EDC software services – including programming – and CRO services.
- Worked directly with clients to serve as “interpreter” to ensure that IT/Programming and Project Management groups were meeting client needs and expectations.
- Work included project management, quality control, and budget/personnel management.
- Created database and EDC specifications, including Case Report Forms (CRFs) and data edit checks.
- Performed quality control of programming work before release to client for User Acceptance Testing (UAT).
- Served as liaison for client comments from User Acceptance Testing (UAT).
- Created and/or reviewed related documentation before release to client (including CRF Completion Guidelines, EDC User Instructions, Randomization Instructions, Data Management Plans, and similar documents).
I have created and provided EDC training for both Sponsor and CRO clients, including training of Data Management, Monitoring, and Clinical staff and training of study site teams.
I have also created and provided competitor awareness training for a major EDC vendor to educate their sales team regarding the features and strengths of competitor products and regarding the needs of EDC clients.
EDC Technology Evaluation and Implementation:
I have evaluated various EDC product options for several CRO clients, so I am aware of the strengths and weaknesses of various currently marketed products.
I have been actively involved in the Request for Proposals (RFP) process for EDC systems, both as a client and as an EDC vendor.
I have also led teams responsible for implementation (including validation) of newly selected EDC systems, as well as related technology products (e.g. pharmacovigilance and laboratory sample management systems).
Case Report Form (CRF) Design Experience:
I have extensive CRF design experience (> 25 years for paper CRFs and > 20 years for Electronic CRFs), including design of standard CRF libraries and modules for many indications/therapeutic areas.
My EDC design experience includes:
- Creating design specifications and validation documents (and performing validation testing) for all aspects of EDC studies, including CRF pages, edit checks, visit schedules, reports, and data import specifications.
- Building CRF pages and electronic data edit checks in various EDC systems.
- Managing teams that performed these activities at both Sponsor companies and CROs.
EDC Systems Used:
- Medidata Rave
- Merge eClinical OS
- DZS ClinPlus
- Study Manager
- Nextrials Prism
- Proprietary Systems