Optimizing Clinical Trials: How Startups Can Leverage Electronic Data Capture Systems for Success

By Tommy Jackson on May 28, 2024

Confession: PowerPoint slides stress me out. I find the idea of creating content from a blank slate, with endless possibilities for layouts, font sizes, formatting, and charts to be completely debilitating. Perhaps one of the reasons I feel this way is because I use at most 20% of the capabilities whenever I create a slide deck.  

I have met many life science entrepreneurs who feel a similar stress when deciding on the best way to manage an electronic data capture (EDC) system for their first clinical trials. Clinical trials represent the cornerstone of innovation in the biotech, pharmaceutical, and medical device industries, driving the development and validation of new therapies and technologies. For startups venturing into the realm of clinical research, maximizing the utility of EDC systems can significantly streamline trial operations and enhance data quality. Here’s a guide on how startups can maximize the potential of their clinical EDC system: 

Hire a Dedicated Clinical Trial Manager 

One of the foundational steps for effective EDC utilization is the appointment of a dedicated clinical trial manager. This individual plays a crucial role in overseeing the design and ongoing management of electronic case report forms (eCRFs), ensuring adherence to protocol requirements and regulatory standards. The alternative to this approach is to completely outsource every aspect of managing the clinical trial. Without a dedicated manager, startups risk losing control of their trial, and consequently their product development timeline and effectiveness. This step is important regardless of whether a contract research organization (CRO), academic institution, or general consulting partner is in the picture.  

Select an EDC Vendor with Hands-On Technical Support 

When choosing an EDC vendor, startups should prioritize providers offering hands-on technical support from experienced builders. First-time users of EDC systems often require extensive training, and having expert guidance can facilitate the adoption of best practices tailored to each trial’s unique requirements. The last thing you want to happen is to have an EDC emergency and be relegated to a generic call center or even a tech support team that is unfamiliar with the potential intricacies of a study design. An experienced builder will share best practices that are relevant to your study design and serve more as thought partners rather than IT support. 

Choose an All-Inclusive EDC System

Many data management tools exist in the clinical research ecosystem. The typical mid-to-large size biopharma or med device company can have upwards of half a dozen software vendors supporting them. As a small organization you can waste a lot of time and resources managing third party systems. For this reason, startups would be wise to opt for an EDC system that goes beyond basic patient data capture functionalities, enabling startups to manage various types of trial-related data within a single platform. Some examples of more advanced data management capabilities include housing protocols, site training documents, consent forms, trial supply management, site payment tracking, and robust reporting capabilities. 

Prioritize User-Friendliness in System Design

Design the EDC system with a focus on extreme user-friendliness to minimize the time clinical operators spend on data collection, monitoring, QA, and cleaning. Ensure that the system is intuitive for clinical site staff, statisticians, and quality assurance personnel, with minimal clicks required to navigate through the platform. Many investigators have rued the day they signed up for a clinical trial because of the challenges they have navigating an unruly EDC system. 

In addition to an easy-to-use interface on the front and back end, a concierge level of service is important to any startup in this post COVID environment where the pressures of labor shortages, supply chain issues, manufacturing delays, etc. put any startup and/or study on the razor’s edge of success or failure due to the downward pressures from time and cost overages. 

Seek Feedback from Investigators Early

Repeat after me: A happy site is a happy life (in the world of clinical trials). Given this, solicit input from investigators early in the design process to optimize the layout of eCRFs. After all, these are the folks who will be using these forms the most as they enter and manage patient information. If investigators are not onboard with the database design, you can expect to hear about it early and often. A collaborative approach ensures that the system meets the needs and preferences of clinical site staff, fostering better engagement and compliance throughout the trial. 

Perform Thorough User Acceptance Testing (UAT)

UAT is one of the more misinterpreted parts of EDC systems. For a refresher, please visit our past guides on the topic. To maximize the effectiveness of your EDC system, conduct comprehensive UAT to identify and address any potential issues or discrepancies before the system goes live. Involve clinical sites and statistical experts in the testing process to ensure that the system performs as intended for their respective roles in addition to meeting the trial’s requirements. Proper UAT will save countless hours of database updates after the study goes live. Better to put in the work upfront to avoid undue stress down the line. 

Create Reports for Key Performance Indicators (KPIs)

Define KPIs early in the trial planning phase and ensure that the reporting capabilities of the EDC system align with the information needed to track trial progress and performance effectively. Customizable reporting features enable startups to generate insights and make data-driven decisions throughout the trial lifecycle. EDC reports should be easy to navigate and build and shareable with all relevant stakeholders. 

Consider Scalability

Choose an EDC system that can scale with your startup as you progress through different phases of research. While some systems are designed for either early-phase or late-phase trials, selecting a platform like Prelude that can accommodate pre-clinical through post-market stages provides flexibility and continuity in data management. A form library that enables re-usability in eCRFs will go a long way in reducing study startup timelines and expenses for future studies. 

In conclusion, startups can unlock the full potential of their clinical trials by being intentional about how they interact with their EDC system. By investing in dedicated management, selecting the right vendor, designing user-friendly interfaces, and prioritizing collaboration with investigators, startups can enhance trial efficiency, data quality, and ultimately, accelerate the path to regulatory approval and market success.