Q.What should I consider when evaluating an EDC Vendor?
A.When evaluating an EDC vendor, considerations should include:

• A user friendly interface
• Overall ease of use
• Level of service
• Knowledgeable staff
• System build times
• System enhancements such as reports and data export functions

Q.We are considering using EDC for an upcoming study. Where do I start?
A.Using EDC as the method of data capture for a clinical trial should not be scary as long as you prepare wisely. Some areas you will want to consider are:

• Type of trials - Some trials just dont "fit" well with EDC. The quick startup times for some Phase I studies and long enrollement times for Oncology studies do not always lend themselves to utilize EDCs benefits.
• Study build times - While build times vary from company to company, you should be aware of how long the build will take and if that time includes UAT testing or not.
• Pre-qualification of clinical sites - It is important to make sure that sites are able to conduct an EDC trial from a hardware, technology and therapeutic area perspective
• COST-Certainlty a key factor for any clinical trial

Q.We are a small company. What are some of the challenges of EDC that we should be aware of?
A.Some challenges of EDC with a small company are lack of personnel to work with the EDC vendor, lack of internal standards, and lack of time (because everyone is doing everything). Octagon brings its vast Data Management expertise and clinical trial knowledge to the forefront of our EDC system, ViewPoint FUSE. We have leveraged a Base Study, built on the principles of SDTM as a way for small companies to not only save time but to also save money using our Base Study forms. These are resuable eCRFs for common forms such as Demographics, Adverse Events, Medical History and Physical Examination.

Contact your Business Development Director to learn more about ViewPoint FUSE.