Seven Reasons Growing Biotechs Bring their eTMF In-House
The electronic master file (eTMF) is essential to submit a clinical trial to regulatory agencies. As part of clinical operations’ active management, the eTMF gives sponsors real-time visibility into quality, timeliness, and completeness across their studies.
Biotech companies starting their first few clinical trials typically do not have the resources to host an eTMF in-house. For this reason, they often outsource to a Clinical Research Organization (CRO) and use the CRO’s applicable software. But, Good Clinical Practice (GCP) mandates that the sponsor is responsible for clinical operations, no matter how much they subcontract to a CRO.
When outsourcing the eTMF to a CRO, the standard operating procedures (SOPs) of a CRO often restrict the sponsor’s external access to the system, resulting in lengthy delays and ultimately a long-term risk for the sponsor.
If the study is successful and moves to subsequent phases, or if Biotech adds new studies to their portfolio, hosting the eTMF with subcontractors limits the Biotech from moving operations in-house or engaging new CROs. Additionally, the sponsor now has to work with various eTMF platforms across their numerous studies.
With the rise of new eTMF solutions focused on these organizations, Biotech’s are choosing to bring their eTMF in-house as they scale. Primarily, this transition is based on seven reasons:
1. Standardize Operations Across Studies
When only conducting one or at most two early-stage trials, a Biotech may not need to standardize documentation and TMF operations. They can rely on the subcontracted CROs to manage the file across meetings, emails, and office visits to maintain GCP-mandated supervision. However, as the study expands to new phases or as they add further studies to their portfolio, they need to standardize processes across studies and CROs.
Bringing the electronic trial master file in-house allows the company to streamline its internal processes for various studies.
2.Maintain Real-time Visibility into CRO Activity
Per GCP guidance, the sponsor must maintain oversight of clinical operations even if they outsource all the work. When the CRO controls the eTMF, their internal SOPs often prevent or severely limit external access, creating bottlenecks of information flow and hindering sponsors’ understanding of potential risks in their most critical documentation.
In addition to standardizing processes to drive efficiency, bringing the eTMF in-house allows the sponsor to maintain active oversight of the CRO and site. They can view all documents in real-time and gain insight into potential delays. Monitoring CRO activity through audit trails, task reports, and dashboards.
3. Accelerate Close-out and Submission
In an industry where days do not only mean the possibility of being first-to-market but also delaying life-saving advancements, the timeliness of a complete eTMF is vital. When a sponsor works with several subcontractors, file assembly, version control, and quality control can take days, weeks, and even months before delivery to the regulatory agency.
An in-house eTMF lets sponsors gain direct access to all the required data across their eTMF to ensure closeout and submission are on schedule. Because the CRO and other subcontractors operate with the sponsor’s system, they can quickly assemble the final file. Even if the CRO must finalize the submission, the sponsor can maintain real-time visibility into submittal status.
4. Build a Foundation for the Future
While some Biotech companies continue to outsource all operations to a CRO, many choose to bring some functions in-house as they scale. When relying on a CRO-owned eTMF, the sponsor has limited ability to work with other CRO partners or move operations internally.
Bringing the eTMF in-house allows for repeatable processes the sponsor can use again and again regardless of how they decide to subcontract in the future.
5. Integrate Directly with Site eISF
With significant advancements in site-based technology, like Florence eBinders eISF now installed at 10,000 study sites globally, sponsors can integrate their eTMF directly with the site eISF to have visibility of the “dark documents” that historically lived in the walls of the research site.
6. Reduce Financial Risk with Cost-Effective eTMF Solutions
Legacy eTMF software rollouts require large capital investments and financial risks. This significant upfront investment does not make economic sense for Biotechs in scale-up and expansion phases. So, they are often forced to hand off their eTMF to a CRO that can spread the capital investment out across sponsors and studies.
Now, the rise of eTMF vendors focused on growing Biotechs allows for a “grow as you grow” approach, limiting financial exposure. Biotechs take on less financial risk while still benefiting from needed eTMF capabilities.
7.Limit Headcount with User-Friendly eTMF
In addition to being capital-heavy, legacy eTMF solutions are human-intensive and require specialized staff members to set up and operate. It is impractical for early to mid-size BioTech companies to assign their limited staff to handle the technical side of the eTMF.
Growing-Biotech-focused eTMF vendors understand these resource restrictions and, in response, build intuitive user interfaces and experiences. Coupled with dedicated sponsor-user support teams and external site and CRO users, an emerging Biotech can ensure success with a limited dedicated headcount to eTMF operations.
Florence helps Biotech and other small, medium, emerging, and scaling sponsors bring their eTMF operations in-house. On Florence, Biotechs get an easy-to-use platform, cost-effective pricing model that scales with you, dedicated support staff, and direct integration with the largest eISF network in research featuring 10,000 study sites in 44 countries.
Download our eTMF capability checklist and schedule a conversation with our experts today to discover how other Biotechs bring their eTMF in-house with Florence.
