A digital ecosystem for clinical trials

Biopharma, academia, hospitals, and contract researcher organizations often operate in relative isolation, each applying their own systems, data formats, workflows, and organizational structures. These stakeholders are reluctant to share research data across institutional boundaries in fear of security and privacy breaches. As a result, data is often scattered across different databases, hampering oversight, accountability and auditability in clinical trials.

In the past decade, a plethora of clinical IT solutions have emerged that aim to smoothen clinical operations and data management. Ironically, the majority of these function-specific solutions are unable to communicate with each other. Fully-integrated platforms do exist, but are far too costly for most clinical research professionals and therefore exclusively for large corporations. As a consequence, many clinical trials lack oversight and significant time and resources are wasted just on staying informed on the trial’s progress.

Clinical trial stakeholders are required to maintain and store trial-related ‘essential’ documents in compliance with quality standards and applicable regulations. To support the correct and effective management of these filing responsibilities, these documents are collected in an electronic Trial Master File, the ‘eTMF’. The essential documents contained within the eTMF should enable regulatory authorities to reconstruct trial activities and key decisions made, providing conclusive evidence that a medicinal product candidate is safe and effective, and qualifies for market introduction. The organization and maintenance of the eTMF can be difficult, especially in multi-country trials that involve a large number of research sites. Consequently, failure in adequate recordkeeping is a persisting industry pain point, leading to significant trial delays as well as costly reiterations of research activities. To illustrate, while academia and smaller industry typically perform the early stages of clinical development, Big Pharma’s involvement is essential for completing the later stages and bringing a candidate treatment to market. Taking over projects from smaller stakeholders, Big Pharma are typically seen to reiterate research activities as a result of documentation inadequacies in upstream trial phases. This results in an enormous amount of unnecessary costs and ultimately delays time to market as well as driving the commercial price of the medicinal product under investigation.

Clinical research has become increasingly complex, globalized, and compartmentalized over the past decade. This has led to an industry-wide need for novel approaches to speed up and streamline communication and interactions between different stakeholders. This need is further fueled by cases of error and misconduct, which have reduced trust among clinical research professionals, patients and regulators, leading to even more stringent regulatory requirements that add to the complexity of clinical research.

The increased complexity and globalization of today’s clinical research stimulates sponsors to outsource a substantial part of their trial-related activities to specialized service providers: contract research organizations (CROs). Selecting the right CRO can make the difference between study success and failure. If any of the contracted CROs fails to be compliant, it can have a significant negative impact on the conduct of the clinical trial, the quality of the trial’s data and the safety of the patient.