There are many important tasks and activities required to set up and successfully run a clinical trial. More than ever, clinical sponsors and CROs are turning to Focused Service Providers to expertly and efficiently manage specific aspects of a trial instead of doing all tasks internally or using a full service CRO. Managing an electronic Trial Master File (eTMF) is a very important clinical trial component and leveraging a focused provider to manage the eTMF can yield significant benefits, enhancing the overall quality and success of clinical trials. Here are six reasons to consider using a focused service provider to manage your study’s eTMF:
- Expertise in ETMF Systems and Best Practices. One of the most common reasons for FDA 483 citations to sponsors relating to their eTMF system is for Inadequate Access Controls. ETMF systems can have a lot of features and functions and the complexity can be even greater when managing visibility permissions for studies. Even the most experienced users can struggle to efficiently and compliantly manage the users in an eTMF.
Case Study: We managed the eTMF for a very large Phase III global trial involving several CROs and an “unblinded” section of the eTMF that hosted the documents for the pharmacy monitors and unblinded safety team discussions. This unblinded section of the eTMF required robust controlled user access to avoid accidental unblinding of the study. A focused eTMF service provider specializes in understanding the systems and can provide the confidence that the eTMF is always audit-ready and can assure controlled access to the most sensitive documentation across countries and vendors. No blinding was blown in this study’s eTMF! - Streamlined Processes and Efficiency The average eTMF system setup time is 3 months. Transitioning an existing TMF to a new system can take even longer. Tasks include user training, building the filing structure, creating metadata, setting visibility and access permissions, adding the sites, persons and organizations, etc. A dedicated eTMF manager can get your eTMF up and running in weeks, deliver any modifications or changes easily and set you on the best path toward success from the start.
Case Study: A recent client was struggling with transitioning a paper-based TMF to an eTMF system mid-study so that there would be global team visibility for the regulatory documents. The shift from paper to digital was so huge (involving tens of thousands of documents) that the sponsor decided to hire a dedicated eTMF service provider to take over the project so that their primary CRO could concentrate on managing the ongoing clinical trial patient visits. By hiring our team and its proven processes and experience, the client enjoyed an almost seamless paper-to-digital transition quickly so there was no disruption with the ongoing study. Incidentally, this device study eTMF enjoyed a clean FDA audit. - Cost-Effective Resource Allocation Outsourcing clinical trial management to specialized contractors is a very popular option to keep administrative overhead low and quality high. In addition to hiring a general CRO or managing the study with internal resources, contracting with focused eTMF service provider can boost study success and eliminate the need for extensive system training or hiring specialized personnel within the sponsoring company. Providers, already equipped with skilled teams and advanced eTMF systems, offer cost-effective solutions compared to doing it all yourself, that is, internally sourcing, validating, purchasing, learning and staffing eTMF systems. This allows sponsors and CROs to allocate resources strategically, saving time and optimizing budgets.
Case Study: A current popular cloud based eTMF system ranges in price between $50K-$100K annually, per study. Labor for one employee clinical trial assistant (CTA) ranges from $50K plus benefits to $150K for a contractor CTA, totaling eTMF minimum costs between $100K-250K per study per year. Using a dedicated eTMF service provider with its own validated eTMF solution can result in a 50% savings and better study timelines. - Risk Mitigation and Business Continuity One of the biggest risks to a study’s success involves key staff leaving the company along with their systems and industry knowledge. This scenario can negatively affect a clinical trial’s progress and knock it off its timelines until new staff can be hired and trained to use the system. Experienced eTMF management providers can mitigate this risk by always having trained staff available to ensure continuity in eTMF management at all times.
Case Study: A recent client enjoyed the sale of one of its newly developed drugs. With the sale, the eTMF archive was transferred to the new owner. Because the eTMF was managed by the focused CRO eTMF provider, there were no obstacles or interruptions in the eTMF service for the new owner. - Low Stress Audits In addition to viewing eTMF hosted documents, auditors may request information about the eTMF system itself. If you are unaware of the technical side of your eTMF, this can cause a great deal of stress for your eTMF operators. Focused service providers have the expertise to quickly address all system related questions.
Case Study: A client readied their staff for an FDA audit, completed mock audits and was very confident about the eTMF completeness due to having the eTMF managed for them. When the FDA arrived, the auditor didn’t want to actually log into the system, but rather asked the sponsor to produce documents from a list. The auditor further asked some very specific questions about the system’s controls and functionality. Luckily, this client was able to rely on its eTMF management provider to be on call to help direct the FDA auditor toward the compliance documentation of the system and answer any questions as relayed by the sponsor. There were no FDA findings from this audit. - Scalability and Flexibility Have you ever worked for a company that committed to an expensive and hard-to-use software product? The product may involve too much work to be worthwhile for small trials or unused or barely used by resistant staff who try to involve work-arounds with spreadsheets to get their work done without the special clinical solutions software. Paying for an unused or unliked product is wasteful. Using a focused eTMF service provider with high-feature software appropriate for the smallest Phase 1 through the largest Phase IV help guarantee happy clinical teams.
Case Study: A company’s IT group in conjunction with a contractor medical monitor made the decision to use an ETMF/CTMS vendor for all studies going forward at the company. The product was ok for a small trial, but once the Phase III study started, the problems with the product became visible. The number of keystrokes and mouse clicks required to load documents made the CRAs very unhappy and slowed their productivity. Reporting features were so weak that they were mostly unused. Even when a few contract CRAs were hired to focus only on the eTMF, it took a long time to get the eTMF up to audit ready status. The company had to spend more and more money on the project and the reconciliation at the end added months to the study timeline. After the disastrous experience, the company decided to migrate off the original platform and use a focused eTMF service provider.