Top 5 Ways to Increase Efficiency Through eTMF/eISF Integration
Here are the top five ways an eTMF and eISF integration can increase overall efficiency between sponsors and sites.
20 March 2015
As sponsors rely more and more on electronic documentation, they are faced with the challenge of reconciling the new electronic process with the largely paper-based process that continues at the site level. With over 80 percent of site documentation still paper-based, it is evident that sites require an electronic solution. eISF was created to fill this electronic need, however, linking this system to eTMF is not as easy as copy and paste.
While some site documents are necessary parts of the eTMF, others are not. In fact, some documents, such as those which would breach subject confidentiality, need to remain separate from the eTMF. In order to meet requirements set by the FDA and the EMA, the two systems need to exist as two separate entities. Specifically, the investigator must remain in control of the site documents. The EMA states “Where all the site records are sent to the external sponsor for uploading into an eTMF system, which the investigator then accesses via a portal, this would breach the EMA recommendation and requirement that the records stay under the control of the investigator.”
To increase efficiency, Intralinks and Wingspan developed an integration that allows for the exchange of specific documents.
Here are the top five integration features that increase overall efficiency between sponsors and sites.
- Automatically pushes appropriate final documents from eTMF to eISF: The integration automatically files sponsor distributed documents as soon as they are approved. Rather than simply copying over from eTMF, the documents are filed in a way that makes sense to the site. This eliminates email or paper distribution.
- Automatically collects appropriate documents from ISF: While the same document may be called a different name in eTMF and eISF, the integration identifies and reconciles any missing or mismatched metadata. It automatically recognizes and collects the required documents from eISF and assigns the appropriate metadata in eTMF.
- Receipt of unplanned documents: The integration ensures sponsors are aware of unplanned documents, such as protocol deviations, in a timely manner.
- Automatically requests documents from site as due date approaches: Wingspan eTMF utilizes milestones to ensure that all documents are received on time. The integration automatically requests the documents needed from the site to support these milestones to the sites — ensuring all documents are filed on time.
- Eliminates the need for wet ink signatures: This feature is a major factor in reducing cost and time associated with a document. Rather than print-sign-upload-check-collect paper, the investigators can immediately sign the original electronic document in a single step. This also eliminates the issue of where to store the original wet ink document.
We hope you find this information useful! If you want to learn more, watch the on-demand webinar that we co-hosted with Intralinks entitled, “Closing the Loop: eTMF and eISF reduce paper and support remote monitoring.”
Kathie Clark is Vice President of Product Management for Wingspan Technology, Inc. She oversees the development of the Wingspan eTMF and other Wingspan products servicing the Life Sciences and Pharmaceutical industries. She has over 20 years of experience in product management, business development, marketing, business analysis, project planning and management, and solution/product design and development. Kathie has worked with over 80 pharmaceutical, biotech, CRO and medical device organizations in the US, Europe, Japan and Israel.