Prepare for the surge of COVID-19 clinical trials!

Prior to the onset of this devastating COVID-19 pandemic, the biotech industry was growing at a significantly faster pace than the broader economy.  In parallel there was rapid growth and specialization of the Contract Research Organization (CRO) market.  Finding an identity as a CRO is a vexing challenge that emerges across multiple dimensions. Are you an oncology CRO, a pediatric CRO, or a rare disease CRO, etc.? Yet a more fundamental question arises around CRO identity. Is a CRO, broadly speaking, a services company or a data company? The answer to that question is a CRO needs to be both. But to effectively manage that balance, a CRO can now begin to view its core service competencies as data itself.  COVID-19 has caused a significant disruption in the clinical trials space because many of the studies in progress had high risk patient populations.   We all anticipate a brief pause in the clinical market in the short term but a significant number of new studies for COVID-19 are on the horizon.  The world needs a vaccine and therapeutic treatments.  It is incumbent upon CROs to identify as COVID-19 specialists.

At AppBus, we believe automation and integration will be a key foundation for this new era in clinical trials.  Our approach is to integrate and automate processes between software applications in the same way that a human would use these applications. By abstracting human work (services) into a library of programmatic services (APIs) delivered by software Digital Workers, we can now build an event-based architecture for clinical trials that allows us to manage the complexity between studies more effectively. Application Programming Interfaces (APIs) have been in use in many industry sectors for decades. In recent years they have become a versatile skeleton on which these sectors have built connective tissue between different parts of software from different vendors, and autonomously driven muscle to deliver valuable business outcomes. Modern APIs significantly increase business agility and reduce implementation and maintenance costs. One of the key tenants of API usage is to build a library of APIs, collectively referred to as an API economy.

Let’s look at how this approach can help us in the context of a specific example. The processing of an adverse event in a clinical trial is typically a very manual process. The adverse event is recorded at the site into an Electronic Data Capture (EDC) system, which may often send an e-mail to a safety specialist at the CRO, who then manually enters that information into a Clinical Trial Management System (CTMS) and a Safety system. This is a time-consuming and error-prone process. Clean data is critical in clinical trials, so a monthly reconciliation process is usually implemented. AppBus provides a platform (AXP) for Digital Workers to enhance this process through integration and automation. Adverse event information from an EDC is automatically processed by an AXP Digital Worker to ensure that event data is handled securely, cleanly and accurately between all required parties. These workers are controlled through APIs that become part of a library of assets that reflect the CRO services and data management. These CRO assets, modelled in software, can be broken down into re-usable common components such as subject enrollment, labs and protocol deviations, to form the skeleton on which future studies can be assembled quickly at start-up. Variances such as visit schedules can be accommodated in a study specific AXP Worker as an exception and added to the CRO asset library. Complexity is managed by reducing each element to a common denominator and capturing that as a CRO asset in an API economy focused around the CRO identity.

Integrations in clinical trials are widely understood to be a challenge in the industry. Veeva, a leading eClinical software provider, recently recorded these data points on the matter:

“Integrating multiple applications (74%) is the top challenge resulting from application and process silos.”

Veeva Unified Clinical Operations Survey

“A majority of respondents (83%) say they have, or plan to have, programs to improve study start-up processes.”

Veeva Unified Clinical Operations Survey

AppBus provides an Application eXtension Platform (AXP) for creating and hosting robust API first automations and integrations delivered by digital workers to address these industry challenges directly. The platform surfaces multi-vendor clinical trial applications as consumable APIs while also allowing humans to be involved in the business process for remediation or regulatory reasons. AppBus dramatically increases the speed of clinical trial management, as these integrations don’t require application modification. These digital workers are built by abstracting human work (CRO services) and turning them into useful APIs (data management). This difficult time is the right time to build a modern API economy for your studies.  The adoption of the innovative AppBus platform AXP can help transform a CRO from a pure services company into a more effective service and data-driven company, so that in the near future, when the wave of COVID-19 studies hit, you are better prepared to contain and defeat this terrible virus and any others that may arise in the future.

Recommended Posts