In the U.S., many agencies and regulations oversee the development of new drugs and healthcare treatments. When these new products reach a certain stage, developers must conduct clinical trials before they can receive approval to distribute the products. These trials produce vast amounts of data, which must be readily available to those conducting the trials, regulatory agencies, and sponsors.
Developers might conduct a single clinical trial simultaneously in multiple locations, creating a need for centralized, streamlined, and secure data collection methods. Today’s technology provides platforms well-suited to clinical trial data needs.
What Is an eTMF?
Every clinical trial must maintain an electronic trial master file (eTMF) which biotech firms can host in-house or through a clinical research organization (CRO). An eTMF contains all required clinical trial documentation.
Your eTMF must be:
- Secure
- Authentic and unaltered
- Compliant
- Audit-ready
Newer biotech companies may not have the resources they can dedicate to managing their eTMF.
Fortunately, platform developers have focused on the unique clinical trial documentation requirements for companies in the biotechnology and pharmaceutical industries. You can now host your eTMF in-house using platforms designed to facilitate an eTMF for emerging biotech companies.
Why Should You Bring Your eTMF In-House?
While using a CRO is a viable option, it has limitations. You’ll realize multiple benefits from hosting your eTMF yourself.
Reduce Sponsor Risks
Sponsors are ultimately responsible for the procedures used, quality control, and accuracy of their clinical operations. However, using a CRO often limits a sponsor’s system access. The resulting delays in retrieving information present a risk to the sponsor.
Clinical trials and traditional eTMF software also require sponsors to make significant financial investments. Emerging and growing biotechs don’t necessarily have the funds or the need for a full-scale eTMF package, and until recently, their only option was subcontracting to a CRO.
Using a scalable eTMF platform grants constant access while reducing financial exposure.
Use Real-Time Advantages
Collaborating in real-time is potentially challenging when clinical trials occur in multiple locations. However, your eTMF can allow real-time document and data sharing so authorized participants can work together easily.
Sponsors and other clinical trial overseers can use real-time data to stay abreast of:
- Workflows
- Timeliness and potential delays
- Quality
- Progress
- Results
Not only does real-time access promote teamwork, but it also provides vital data for informed decision-making and compliance.
Keep Systems Secure
Your eTMF should protect your clinical trial data and intellectual property using:
- Safeguards to prevent unauthorized data transfers
- Internal and external threat management tools
- Data classification systems to ensure privacy
- User access tracking
Today’s eTMF solutions also allow organizations to manage user access permissions.
Standardize Processes
As biotech companies grow, so do the number of their clinical trials and the amounts of data these trials produce. For every trial, you need to maintain extensive documentation, including:
- Audit: audit results and onsite visits
- Ethics: protocol approvals and amendments
- Funding: budgets, negotiations, and contracts
- Participants: patient journals, brochures, and recruitment materials, and informed consent forms
- Safety: serious adverse event reports and advisories
- Study: investigator’s brochure, protocols, manuals, procedures, and visit guidance
- Training: materials, supporting content, and certificates
Documents may exist in multiple forms, including emails, meeting records, lab reports, and videos. Having a central repository that can classify, sort, track, and retrieve all documents effectively and developing a set of standardized processes using a powerful eTMF makes it easier to enter and find data across all of your company’s studies and trials.
Integrate With Your Existing Software
Companies today rely on multiple software applications to facilitate their business needs. When you add a new application, you must ensure it integrates seamlessly with your existing software package.
Typical apps include:
- Google Workspace or Microsoft Office
- DocuSign
- Teams or Zoom
- Industry-specific apps
Your research site typically houses most of the documents included in an eTMF. Integrating this data with your eTMF platform allows sponsors to view it.
Ensure Timely Submission
Regulatory agencies have specific requirements for clinical trials and the resulting eTMF. Waiting for subcontracted CROs to compile and complete your eTMF can take months. During that delay, needy patients cannot access your new product, and other companies may reach the market first with a similar product.
Using an in-house eTMF gives sponsors more control of the final file assembly, submission process, and status.
Growing biotech companies gain flexibility and control by using a scalable, in-house eTMF.
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