“This year, we’ve decided to stick to paper. We know what we’re getting and we’ve always done it this way.”
That was the unwavering response from a clinical operations lead at a pioneering biotech when asked why they still relied on paper diaries for patient-reported outcomes.
Despite the growing complexity of global trials, the promise of real-time data, and the surge of digital capabilities available today, some organizations have held tight to a method of clinical trial conduct that’s increasingly as outclassed as it is outdated.
It’s well known that individuals and organizations believe that change can be daunting, stressful, and difficult, especially when the old way is familiar and entrenched. However, much like anything else, having a partner who can help guide you through the process is massively important. But, how do you find the right partner for your trials?
Before locking in a vendor, organizations must engage in a deliberate process to assess their needs, align stakeholders, and set the foundation for long-term success. This blog explores the critical steps sponsors should take before selecting a digital partner, using insights and frameworks drawn from Medable’s therapeutic area standards and industry best practices.
Step one: Start with the problem
One of the most effective ways to ensure vendor success is by starting with clarity around the core challenges your organization is aiming to solve. Before discussing technologies or platforms, sponsors must first identify and articulate their trial-specific and portfolio-level problem statements. These include real, multi-trial persistent issues such as patient retention, site burden, long study startup timelines, inconsistent data collection, or challenges with protocol complexity.
The importance of this diagnostic step cannot be overstated. Many organizations jump in with digital and end up retrofitting their platform to their studies, this is not an ideal way to tackle transformation.
Instead, define your operational, clinical, and scientific pain points and then work backward to find the right digital solutions. Problem statements should be specific, measurable, and aligned with the unique characteristics of your therapeutic areas and past trial designs. Taking the time to define these pain points lays a strong foundation for strategic alignment with your digital partner, ensuring that every tool and deployment maps back to a meaningful outcome.
Step two: Tailor technology to your trial architecture
Once the problem has been clearly defined, the next step is to select technology that aligns with the architecture and complexity of your clinical program. Trial designs today are rarely one-size-fits-all. Adaptive protocols, basket and umbrella designs, and global studies with diverse populations require platforms that can flex and scale without compromising regulatory rigor or patient safety.
At Medable, we address this challenge by offering therapeutic area (TA) standards. These are modular, pre-validated components such as eCOA libraries, reusable diaries, and unified data flows that can be tailored to fit different studies.
This blend of standardization and customization is vital towards success. It enables sponsors to shorten build timelines dramatically. In fact, some of our own case studies show reductions from 28 weeks to just 7 weeks, through a combination of standardization and customization.
For instance, when selecting a partner, sponsors must ask:
- Can this vendor support BYOD and provisioned devices?
- Do they offer validated tools for my specific TA?
- Can they handle mid-study amendments with minimal disruption?
- Ensuring the platform architecture fits your study helps minimize risk across your pipeline.
Step three: Ensure alignment with stakeholder outcomes
Clinical trials are complex ecosystems that depend on the coordination of sponsors, sites, patients, caregivers, regulators, and CROs. For a digital trial strategy to be successful, technology must serve each of these groups meaningfully.
Before choosing a vendor, sponsors should evaluate how the platform improves the problems and challenges outcomes across stakeholders. For instance, does the solution:
- Reduce site burden through automation and intuitive workflows?
- Does it engage patients more effectively through timely reminders, caregiver access, or BYOD functionality?
- Does it help sponsors make faster decisions with real-time, clean data? etc.
Vendors should have a model that outlines specific questions that evaluate the broader impact of a solution. A vendor’s ability to enhance efficiency across the ecosystem should be a prerequisite for adoption. If sites or patients struggle with the platform, compliance will suffer. If sponsors cannot quickly access data to drive decisions, the trial’s operational excellence is compromised. Look for vendors who understand the interdependencies across your trial ecosystem and who have the tools and experience to deliver measurable benefits to each stakeholder group.
Step four: Vet for standardization, but ensure room for personalization
One of the most overlooked factors in digital vendor selection is the ability to strike a balance between standardization and personalization. Standardization brings speed, consistency, and reduced variability which are essential qualities for portfolio-level deployments. However, overly rigid systems can fall short when trials require more nuance and flexibility.
Medable’s approach to standardization leverages validated TA configurations, reusable modules, and AI-enabled workflows that drastically cut down on repetitive decision-making, reduce email traffic, and save hundreds of hours per study.
At the same time, the best vendor technologies, like Medable's, enable sponsors to overlay their own specific workflows, terminology, and protocols. This hybrid model supports both scale and uniqueness, allowing sponsors to move faster without reinventing the wheel every time.
When evaluating vendors, sponsors should ask how configurations are managed, whether prior builds can be leveraged across programs, and how much effort is required to introduce protocol-specific nuances. A platform that can evolve with your pipeline is a strong signal of vendor maturity and long-term value.
Step five: Analyze your pipeline in comparison to the vendor’s performance
Assessing internal readiness is another crucial step. Specifically, this means organizations must be able to understand the composition of their clinical pipeline and the internal stakeholders responsible for digital decision-making. For instance:
- Have previous studies used eCOA or eConsent tools?
- What are the key endpoints, and are they compatible with digital capture?
- Are trials global, and does the vendor offer localization and translation at scale?
- Are there regulatory requirements for data submissions that the platform must support?
These are the types of questions that reveal not only the potential fit between sponsor and vendor, but also where internal alignment may need to be strengthened. By conducting this self-assessment, sponsors can anticipate barriers to adoption, tailor their vendor evaluation criteria, and ensure the platform fits both their current needs and future ambitions.
Step six: Look beyond your pilot and plan for portfolio-level efficiency
Perhaps the most critical mistake sponsors make when choosing a digital trial partner is focusing too narrowly on a single study or pilot. While a small-scale deployment can serve as a proof of concept, true value emerges when tools and workflows can be scaled across your pipeline. The best vendors address this by offering a governance framework for standard packages, a feedback loop for continuous refinement, and the ability to track reuse rates, deployment timelines, and stakeholder satisfaction across studies. These metrics are crucial in helping sponsors evolve from one-off trial digitization to full portfolio transformation.
- For instance, organizations must ask:
- Can this partner grow with us?
- Do they have proven success across multiple therapeutic areas?
- Can they support our future needs for LTFU, real-time monitoring, or AI-driven insights?
A successful digital partner should not only deliver on today’s goals but be a trusted collaborator in tomorrow’s challenges. Planning for scale and adaptability ensures that your digital strategy is sustainable, efficient, and continuously improving.
Conclusion: Choosing the right partner matters
In conclusion, choosing a digital clinical trial partner is not a decision to be made lightly. It demands strategic foresight, cross-functional alignment, and a commitment to both short-term execution and long-term innovation.
By taking the time to define your problem statements, assess trial design compatibility, align stakeholders, and interrogate both vendor and internal readiness, sponsors can make informed decisions that deliver true operational and scientific value.
A strong digital partner offers your organization true transformation, not just tools. By approaching the vendor selection process thoughtfully and comprehensively, sponsors can unlock the full potential of digital trials and build a foundation for clinical excellence that scales for their future.
