Electronic Regulatory & Study Binders

Whether you are a pharmaceutical, biotechnology, medical device company or CRO, all clinical trials collect regulatory documentation to receive authorization to conduct begin the trial at investigative sites. Trials require a Regulatory Binder and many keep a separate Study Binders, synonymously called Investigator Binder or Study File. Some sponsors provide the binders to the investigative sites while others mandate that the investigative site personnel compile and maintain them.

Regardless of who prepares the Regulatory Binder and although the ultimate responsibility to maintain it lies with the investigator, both the sponsor and investigative site personnel have a vested interest in keeping it accurate and current. It should be available for Clinical Research Associate site visits, sponsor personnel, any subcontractors of the sponsor, institutional auditors and/or any regulatory authorities visiting the site for the purpose of an audit.

Unfortunately, the majority of the companies and CROs and investigative sites that are key stakeholders in the execution in clinical trials still distribute and maintain these binders in paper form. Some investigative site personnel maintain a hybrid of paper and electronic, completing the required essential documents, then sending them by courier or fax to the sponsor or CRO. The sponsor may scan some of the documents providing them in electronic format however, many of the study manuals, etc are still then provided in paper format via Study Binders and/or Regulatory Binder.

Trial Interactive offers a complete solution for electronic distribution of essential documents and other sponsor and/or CRO forms that are required to be completed. These forms can be auto-populated with site-specific information prior to distribution to study site personnel and all information, including the electronic signature can be completed virtually, yielding a paperless process. Trial Interactive includes workflow to promptly facilitate the review and approval by the trial sponsor and then provides an organized, searchable electronic Regulatory Binder and Study Binders if required by the sponsor or institution. This provides advantages for all trial stakeholders including:

• Prompt submission of documents needing review and approval to sponsor
• Shorter cycle time for approval of all documentation reducing the time to study start up
• Indexed electronic binders that mimic what is kept in paper format
• Clinical trial template forms available for use or configuration per trial; sponsor, CRO or investigative site forms can be used alternatively
• Real time availability of information to CRAs and institutional personnel needing access to review information
• Search capability allows investigative site personnel to quickly find documentation rather than flipping through binders tabs and reams of paper
• Archival at the end of the trial offers an easy searchable index should an audit be required without potential loss of paper or binders throughout the trial or upon close-out due to poor archiving processes