Site Assessment Services

Investigator site acceptance and use of EDC is instrumental in the success of accelerating clinical trials data collection and FDA acceptance of drug application submissions. Many investigator sites are not part of a biopharma’s decision-making process to use EDC and are often resistant to the technology. Furthermore, many investigators are not prepared to implement EDC from a computer hardware and Internet-access viewpoint. In turn, investigator sites may cause trial delays since extra time is needed to configure the site for efficient EDC operations. EDC Management can facilitate investigator site communications and assessments to insure an effective EDC deployment, either for an initial company-wide roll-out, or for a single clinical trial protocol.

Site Assessment Offerings:
EDC Pre-Adoption Assessment
•	Assessment of clinical trials, number of sites and location of sites
•	EDC survey of investigator sites, including technology
•	Summary site report on hardware, Internet and computer expertise
•	Conclusive assessment to support an EDC decision
Deployment and Technology Assessment
•	Survey and analysis of investigator’s hardware and Internet capabilities
•	Site visits for issue resolution
•	Summary site report on hardware, Internet and computer expertise
•	Planning and execution of site upgrades
Ongoing EDC Site Training and Support
•	Survey of prepared investigator sites
•	Comprehensive site training
•	Help desk support

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EDC Management
P.O. Box 23 Conshohocken, PA 19428
484-530-0300 Fax: 610-567-0357
Email: info@edcmanagement.com

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