Partners for Success: Governance Best Practices to Streamline eCOA Trial Launch

The stage for a successful clinical trial is set long before the first patient is enrolled. Strong and meticulously planned fundamentals—protocol development and study design, site selection, patient recruitment strategies, end point determination, tool selection, data capture methods, and more—are non-negotiable.

I’d like to add another element to this list: Effective technology governance rooted in a strong vendor/sponsor-contract research organization (CRO) relationship is also essential for trial success. Prioritizing technology governance in close collaboration with key stakeholders in the clinical trial ecosystem can significantly accelerate time to electronic clinical outcome assessment (eCOA) trial launch; improve patient engagement; facilitate high-quality data capture; and, ultimately, ensure overall trial success.

Governance can have many different meanings in the context of clinical trials. In this instance, we’re referring specifically to relational governance—in other words, the framework and processes that define how a technology vendor and sponsors/CROs work together to bring a study or portfolio of studies to market and address challenges that may emerge.

Effective relational governance happens by design, not accident. It is important to embrace a dynamic approach that’s collaborative, end-to-end, proactive and reactive, and fortified through open dialogue as well as continuous improvement.

This model of governance extends beyond the delivery of a single study. It includes portfolio and program management spanning multiple clinical trials, ensuring alignment with strategic objectives, proactive risk management, and optimized resource allocation across programs. A key component is delivering consistent, high-quality service across all engagements, regardless of study size or complexity.

In addition, effective governance supports adherence to client-specific standards, including processes, documentation requirements, and regulatory expectations. This is reinforced through ongoing training programs to ensure that all involved teams understand and apply these standards accurately and consistently throughout the life of the engagement. Ultimately, strong relational governance fosters transparency, accountability, and long-term partnership success through structured collaboration, mutual understanding, and a shared commitment to excellence.

So, what does this look like? Let’s explore four pillars of a governance approach and how they can drive success.

1. Effective governance starts and ends with strong communication

I recommend an approach that starts with establishing a robust communication and operational framework that ensures a transparent flow of information, creating a shared mutual understanding among all partners. This framework also helps to identify the people and resources needed to achieve objectives and proactively address risks and challenges.

Communication covers the who, how, what, and when:

• Who the vendor communicates with includes key stakeholders across the organization—procurement, senior leadership, and other business units.
• How the vendor communicates spans formal and informal channels, including metrics, KPIs, and a knowledge base. This also encompasses the use of design standards, which are essential components of a communication process. These standards help build a client-specific library of information that includes agreed terminology, questionnaires, branding guidelines, design templates, and user acceptance testing (UAT) expectations.
• What the vendor measures should include clearly defined KPIs and milestones, such as build time, UAT timelines, including helpdesk response times, and more. Regular meeting cadences should be established for status updates and issue resolution, and more. In addition, clients should be able to access dashboards for ongoing visibility into progress.
• When refers to the frequency of communication. Project-related meetings should typically occur weekly, while governance discussions should be scheduled monthly and often quarterly.

Further, the vendor’s project managers and governance teams should work in lock step to ensure complete transparency internally and with the sponsor-CRO. Ultimately, a governance model should seamlessly extend from the overall project management approach, ensuring consistency, accountability, and trust throughout the engagement.

2. The customer success team is empowered to take action—and do so rapidly and accurately

Clinical trial protocols are complex, and challenges will arise. The difference is in how a vendor responds. The vendor’s team should be empowered to take action and do so rapidly. While rapid response is critical, accurate responses are essential to streamline problem-solving and keep study launch timelines on track.

When an issue arises with a particular study, the vendor should be ready to respond—quickly garnering a core internal team that is aligned and prepared to take action and provide regular updates both internally and to the client. If the client has additional active studies in their portfolio, the vendor should also communicate and immediately assess the issue across all studies to ensure consistent messaging and transparency. Should an issue affect multiple studies, risk assessment should be conducted to determine how to effectively prioritize remediation and track progress in a centralized system.

3. Governance is equally proactive and reactive

Issue avoidance is just as important as effective issue resolution. The vendor should continually gather and analyze customer feedback on its solutions and their implementations to drive improvements and future solution enhancements. A vendor might collaborate with clients around its data change process to drive the development of a new self-serve data change feature, an enhancement that could save considerable time for sites and reduce complexity during data reconciliation.

4. Never stop learning and evolving

Vendors should review all studies upon completion to assess performance—identifying what went well and how it can be applied going forward as well as reviewing challenges, the vendor’s response to them and lessons learned for future studies.

For example, a vendor might identify opportunities to reuse a client’s specific questionnaire modules, dedicated blocks of functionality included on app interfaces, and language translations. When managed and controlled at a governance level, this type of best-practice reuse can help to ensure high data quality and can significantly reduce time to study launch.

Collaboration is key to continuous learning. When the vendor’s various project teams regularly share concepts that have worked well, they can apply these learnings broadly across a client’s studies. Establishing a mature well balanced governance structure built on trust and transparency enables project teams to proactively recommend enhancements to eCOA trial designs.

Relational governance is a critical pillar in clinical trial success. Elements for a strong governance foundation include clearly defined roles; transparency and open communication; empowerment to act decisively and rapidly and a commitment to continuous learning and improvement.

Together, these fundamentals can be a powerful force that fosters trust and builds strong vendor/sponsor-CRO relationships. Equally important, they can significantly improve quality, reduce issues, and accelerate eCOA trial launch time.

Rhiannon Hyde is Director, Governance and Transformation, uMotif