The Benefits of Taking a Comprehensive Approach to eTMF Management and Archiving

August 18, 2014

  • eTMF Resources

This is a guest post written by Rachel Belani-Barker of InnovoCommerce LLC.

From Day 1 of study start up, most sponsors strive to streamline eTMF filing and rely upon a mix of document exchange and/or portal solutions to ensure trial documents are inspection-ready. Given the recent EMA direction regarding management of the eTMF, sponsors are now seeking ways to ensure the trial’s TMF completeness, accuracy and availability. This starts with finding a clinically-focused collaboration engine or exchange mechanism to centralize document completion. There are three main approaches in the market today:

  1. Legacy Approach – traditional document exchange
  2. One Platform Approach – eTMF is extended to allow collaboration with sites
  3. Comprehensive Approach – purpose-built investigator portal seamlessly integrated with, or potentially a component of, an eTMF solution.

Unlike the first two, Approach #3 (the Comprehensive Approach) goes beyond traditional document exchange and management by allowing sites, sponsors and CROs to seamlessly collaborate and communicate from study planning through closeout. The perspective of the investigator and their site staff is of paramount importance. When it comes to processing trial documents, supporting communications, and accessing one stop for training and status updates, investigator sites need a simplified approach to ensure that timelines and quality standards are met.

A best-of-breed investigator portal allows the site staff to work remotely with their study team to ensure study start-up documents are completed in an accurate and timely fashion. In addition, the purpose-built investigator portal centralizes the delivery and archiving of site training, site communications, and other elements that become part of the eTMF. This results in a closed-loop ecosystem, allowing for automated distribution of documents that originate in the eTMF (e.g. protocol) and automated, intelligent transfer of completed records (e.g. Financial Disclosure) back to the eTMF.  Training records, site communications and other eTMF elements contained within the investigator portal are also automatically archived in the eTMF.  Investigator portals typically allow for clinical and quality approval to occur within the portal itself, eliminating the need for dual quality check processes before the document truly becomes an eTMF record.  Thus, the integrated approach reduces the cost and improves the overall quality of eTMF archiving.

While Approach #2 (One Platform Approach) can work for some sponsors, it typically requires acquisition or integration with external solutions (such as LMS or custom site training platforms) to ensure all records are transferred to the eTMF.  This approach does not offer an effective way for sponsors to offer eISF management for their sites.  Many of the One Platform Approach solutions on the market do not support site training or secure communication, and therefore sponsors/CROs inherit additional cost and risk to ensure the integrity of the eTMF during each phase of the trial.  The One Platform Approach does not take into consideration that sponsors leverage multiple CROs and end up spending considerable amounts of funding on CRO-specific integrations, CRO data transfers, and sometimes on extra CRO headcount to accelerate manual reconciliation of the eTMF (when no standard collaboration engine such as an investigator portal is in place).

Unlike the extended eTMF, an investigator portal can plug and play with various eTMFs and reduce spend on custom efforts that typically cannot be re-purposed for future engagements. Legacy solutions bring similar challenges to the sponsor and sites. These solutions typically do not have site training, investigator safety reporting, investigator network building, or collaboration capabilities outside of document management.  With Approaches 1 and 2, the site experience becomes fragmented, which also negatively impacts adoption and adherence to the processes that enable high-quality eTMF management.

The Comprehensive Approach creates a closed-loop ecosystem, enabling sponsors and CROs to realize cost savings and operational efficiencies over time.  Wingspan and InnovoCommerce’s integrated portal-eTMF platform provides sponsors and CROs with the capabilities they need to maximize operational efficiency and set higher quality standards for inspection readiness.

Specialized portal solutions such as  innovoPOINT clinical and investigator portal offers sponsors and CROs a comprehensive approach to clinical collaboration, including completion of site training, secure transfer of site communications, and centralization of study support documents, such as Q&A trackers, FAQs and newsletters. The innovoPOINT portal is fully integrated with the Wingspan eTMF meeting the Comprehensive Approach described above.

Meet Our Guest Blogger

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Rachel Belani-Barker is Clinical Solutions Director at InnovoCommerce LLC, where she drives enhancements and inform product roadmap for innovoCommerce’s clinical portal solution (innovoPOINT) and clinical trial management office (CTMO).  You can contact Rachel at info@innovocommerce.com to learn more about optimizing your eTMF archiving and management strategy.