Given the shifts that Contract Research Organizations (CROs) and the pharma industry have gone through with the COVID-19 pandemic and subsequent changes to how clinical trials are managed and run, what does this mean for CRO outsourcing trends in the industry? Based on a March 2022 article in Applied Clinical Trials, the demand for CRO services will increase, with demand especially for those with experience in Decentralized Clinical Trials (DCTs) and technology-driven solutions.1 How does this relate to Functional Service Provider (FSP) services rather than delivery by the more typical full-service provision?
What we see as drivers to delivery via a FSP model within the current environment are:
Obtaining and retaining qualified and experienced staff is an issue that currently plagues the general workforce overall, and the biopharmaceutical industry in particular. Rather than keeping staff on a project-to-project basis, as found in the full-service approach, the FSP approach can maintain the team across projects. These dedicated resources become integrated with client teams and drive synergies and cost efficiencies. Rather than switching to another provider because of high turnover rates, aligning with a CRO that has proven capabilities for hiring and retention is a strength to look for.
Flexibility to ramp staffing up and down based on the needs of a study is an option that many clients appreciate. The ability to ensure skilled resources are available at the anticipated study start up and are quickly able to scale-up the resource count as required by the project(s) is vital. In case additional recruitment efforts are needed, the process is expedited to meet study timelines. Or perhaps resources need to be moved between two or more projects in order to most effectively use the needed talent. While there are different models that may be offered, e.g., a fixed head count vs. a variable head count, the options should be there to fit the needs of the study and client.
In addition, having a range of services and expertise from which to draw from, on a periodic or regular basis, provides assurance that study and client needs can be covered across a multi-discipline platform.
EXPERIENCE IN DCTS AND HYBRID MODELS
Over the past two years, a major change in clinical trial operations has been the ability to conduct the trial on a decentralized basis, allowing the remote collection of patient data through telemedicine and limited on-site visits. Technology to obtain data may include wearables and other digitalized tools for the measurement of study objectives (e.g., pain, quality of life, cognitive function). The ability to adapt to new technologies, as well as the protection, storage, integration and analysis of these various sources of data needs to be considered, and a plan developed. Having a provider with experience in this area, who can lend the necessary support and training to the FSP team is essential.
There is a need for CROs to be technically savvy in order to better handle the operational changes and complexities of today’s trials. Based on new and varied sources of data coming in from DCT trials, expertise in data aggregation, AI, machine learning, visualizations and tools to aide with Risk Based Monitoring are increasingly used to automate and streamline tasks that support the study team throughout the trial. The FSP solution can go beyond a simple head count for a data management staffing shortage. The solution can respond to filling short-term talent gaps in competencies that deal with new technologies and new tools that streamline and harmonize oversight of the trial as well as bringing in expertise from some of the other, more traditional services (e.g., Medical Writing, Pharmacovigilance, EDC build/Database developers and Clinical Data Management, Biostatistics and Statistical programming).
While presented last, the deciding factor to select a FSP provider rather than a full-service provider, for many clients is cost. FSP solutions are decidedly less expensive than most full-service provider solutions due to simplified financial and project management, eliminating redundant activities, enhanced productivity, lower operational costs and flexibility. An additional advantage is the elimination of change orders. While tasks may change the costing is decided upfront and based on monthly resources, not tasks or units. The Veranex Data Management and Analytics team provides coordinated services in Clinical Data Management, EDC Builds, Biostatistics and Statistical Programming, Pharmacovigilance, Risk Based Monitoring and Visualizations, and Medical Writing. We’re here to help.