The digital health market, particularly the electronic Clinical Outcome Assessment (eCOA) space, is experiencing an inflection point. As clinical trials evolve to embrace more inclusive study designs, simplified deployment models, and richer data endpoints, sponsors are re-evaluating how they approach digital data collection.
Many sponsors have already realized the benefits of eCOA such as improved compliance, reduced patient burden, higher-quality data, and faster decision-making. Yet, the path to these benefits has often been fraught with delays, unanticipated costs, and reliance on third-party vendors. Pharma companies are frustrated by complex workflows and extended study start-up times. They are now asking: Should we bring eCOA solutions in-house?
The ability to control digital design and deployment is enticing. However, the decision to internalize eCOA capabilities is a complex one. Success requires a fundamental shift—not just in technology adoption but in business processes, data management, and operational workflows. Before taking the leap, sponsors must consider multiple aspects. Below, we outline key questions to answer when bringing eCOA in-house.
1. Is the Platform the Problem, or the Process?
Many pharma companies view platform selection as the key to unlocking in-house eCOA success. But is technology really the limiting factor? Modern eCOA platforms do offer more accessible study design capabilities. Yet they still require thoughtful workflow design, robust data integrity checks, and regulatory alignment.
Therefore, selecting a platform is really just the first step. The true challenge lies in aligning technology with strategy, balancing patient usability with protocol requirements, integrating diverse data streams, and maintaining compliance without unnecessary rigidity. Integration with other systems, wearables, and data warehouses is key.
Key Question: Is our end-to-end clinical program workflow ready to support a new platform?
2. The Hidden Complexity of Digital Design
Bringing eCOA in-house means taking full ownership of digital study design. This goes beyond “point-and-click” software configurations. It requires expertise in:
- Data integrity and patient behavior. How do we ensure compliance without creating unnecessary burden?
- Protocol amendments. How do we design proactively to minimize costly mid-study changes?
- Regulatory approvals and translations. Are we ready to handle the nuances of ethics committee requirements, licensing agreements, and localization needs?
Key Question: Do we have the internal expertise to manage these complexities efficiently?
3. Bridging the Gaps: Process, Tools, and Integration
eCOA platforms may streamline digital data capture, but they do not automatically integrate into the broader clinical trial ecosystem. Key operational challenges include:
- Ensuring seamless integration with EDC (Electronic Data Capture), CTMS (Clinical Trial Management Systems), and regulatory submission tools.
- Managing device logistics, site training, and patient engagement strategies.
- Establishing risk-based monitoring to detect and mitigate data inconsistencies in real time.
Bringing eCOA in-house is not just about technology. Rather, it requires a fundamental shift in clinical trial execution.
Key Question: Have we evaluated the impact of eCOA adoption across all clinical workflows?
4. Who Owns the Risk? Project Management and Oversight
Internalizing eCOA development shifts risk from vendors to sponsors. This means that clinical teams must now take responsibility for:
- Regulatory compliance and validation processes.
- Timely system builds and software updates.
- Vendor oversight and third-party integrations.
In an industry where delays can cost millions, even minor missteps in digital deployment can have cascading consequences.
Key Question: Are we ready to manage the increased risk of in-house digital execution?
5. Change Management: A Mindset Shift, Not Just a Technology Shift
Suprisingly, the biggest barrier to bringing eCOA in-house isn’t necessarily cost. It’s organizational change. Successfully internalizing digital health solutions requires rethinking how clinical teams:
- Plan and design protocols with digital endpoints in mind.
- Train personnel to manage technology-driven processes.
- Adapt to iterative digital development cycles instead of static trial timelines.
Key Question: Is our organization equipped to embrace a digital-first clinical trial strategy?
The Future of In-House eCOA: A Strategic Opportunity
Pharma companies now stand at a crossroads. They can continue to rely on external eCOA providers with limited control. Or, they can take ownership of their digital strategy by building internal capabilities.
The truth is, there is no one-size-fits-all answer. The decision to bring eCOA in-house must be driven by long-term strategy, not short-term frustrations. Companies that invest in the right talent, infrastructure, and governance models may gain a significant competitive advantage by reducing costs, accelerating trials, and optimizing patient experiences.
However, for those who underestimate the complexity, the shift could result in costly missteps, regulatory hurdles, and unforeseen delays.
So, the question remains: Is your organization truly ready to take control?
