How CROs can Simplify Operations, Increase Quality and Compliance through eTMF Platform Standardization

Contract Research Organizations (CROs) are challenged to deliver ever-increasing industry knowledge and exceptional service to their Sponsor clients in the drug and device development market. Sponsors look to CROs for their expertise in particular areas of science, therapeutic specialization, evolving regulatory requirements, process, and data management – all while providing exceptional service.

Effectively managing operations for a small to mid-sized CRO requires both in-depth expertise and an extensive range of skills. Larger CROs are more likely to have specialists in all aspects of the business and thus can rely on in-house departments to fulfill their internal and client-facing needs. The small and mid-sized CROs, who make up the largest share of the market, are often hired because of their specialized knowledge around a specific disease or field of clinical activity. These CROs may have expertise in the clinical, regulatory and quality components of their particular field of focus but managing the technology to support efficient operations and client expectations may be a challenge. For many CROs the technology aspect of their operations takes a back seat to the scientific and management facets of their business. They may either fall back on using the sponsor’s technology systems or use whatever systems the assigned project manager has used in the past and deems the path of least resistance. Unfortunately, this does not always yield the best results from an efficiency, consistency or a quality perspective.

In our work with CROs, Court Square Group has seen numerous Clinical Research Associates (CRAs) that regularly need to access multiple systems for different sponsors’ projects. A single CRA might even have multiple laptops based on what systems are being used for different sponsors and projects. Working on multiple systems requires additional training for each software and every time a new project starts. Even when using the same system for different sponsors, each sponsor may want the system configured differently from other sponsors. In the highly regulated world of clinical research quality and consistency are critical. Achieving consistency and efficiency will improve client satisfaction as well as CROs’ bottom line.


To improve operational efficiency and client satisfaction CROs need a system and approach that brings consistency and quality to the capture of clinical content and documents from multiple sites across multiple clinical trials. The price tag of the largest systems puts those systems out of the reach of most CROs. The small and mid-sized CROs need a system that is easily configured, contains robust 21 CFR Part 11 capabilities, and has the regulatory requirements built in. CROs can greatly benefit from an environment in which they can create a project template approach to their studies. The project template approach makes it simple to set up each study in a consistent manner that will require minimal training for CRAs and enable them to work on multiple studies without having to utilize different hardware or login to multiple systems. By starting with the DIA eTMF reference model as a foundation, CROs easily add to meet specific project needs such as multi-country trials.

In a market that is driven by scientific expertise, regulatory compliance, and customer satisfaction it is critical to maximize operational efficiency and minimize the distractions of competing technology systems. Standardizing on an easy to use and cost-effective eTMF platform may help CROs to simplify operations and increase quality and compliance.