How FSP Solutions Support Risk-Based Methodologies and Tech Innovation in Clinical Operations

The systems that make up the core of clinical operations have evolved from traditional monitoring to risk-based quality management (RBQM), cross-border monitoring and more. Success requires guidance from highly skilled professionals using leading-edge technologies, which functional service provider (FSP) engagements deliver.

Biopharmaceutical, biotech and medical device developers can choose from a range of options to support effective clinical operations across critical functions such as clinical monitoring, site management, clinical oversight, support services and site engagement. In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.

A recent white paper from the PPD™ clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized. Sponsors find that an FSP solution is often the best choice to help advance their drug development projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions. An FSP partner can increase flexibility and provide access to the very expertise a project needs, precisely when it is needed and in just the right amount.

By harnessing the full range of innovative technologies and taking advantage of an FSP partner’s extensive skills and experience, sponsors are able to bring their therapies to market more quickly and within budget — even in the face of complicated global regulations and widely fluctuating workloads.

Technology innovations are essential in clinical operations

While skilled and experienced FSP staffing is key to successful outsourcing of clinical operations, technology also plays an important role. Today’s clinical trials rely on technologically sophisticated systems that require complex integrations to capture and process all manner of data across multiple sites, often spread throughout multiple countries or jurisdictions. By supplying specialized, cost-efficient resources and talent, an FSP partner supports the delivery of a wide range of technologies.

Electronic medical records (EMRs), for example, exemplify the evolving role of technology in clinical trials. With their focus on uniformity, accuracy and convenience, EMRs enable more cost-effective and efficient centralized monitoring. EMRs give clinical operations teams direct, remote access to an array of patient health information. The ability to automatically pull this spectrum of data into the trial sponsor’s research significantly reduces manual data gathering and entry.

RBQM is another tech-enabled innovation widely used in clinical operations. It encompasses systems and processes used to identify, assess, control, communicate and review risks throughout clinical trials. Central to this framework is the concept of risk-based monitoring (RBM). In contrast to traditional source data verification and source document review methods focusing on past events, RBM draws upon forward-looking capabilities, such as real-time monitoring and predictive modeling. These influential trial management practices are made possible through tech-enabled monitoring, often in these forms:

• Off-site/remote monitoring: By converting on-site monitoring visits to remote monitoring, a trial operator gains efficiencies and reduces costs while enabling a wide range of data to be quickly and seamlessly incorporated into its research. Remote monitoring is also more resistant to disruption and can proceed regardless of a given CRA’s physical presence at a site.
• Centralized monitoring: Through reviewing aggregated electronic data gathered remotely and performing data analysis from a centralized location, trial operators increase consistency and efficiency. Additionally, sponsors may find cost savings using remote or “offshore” resource centers.

Remote and centralized monitoring both accelerate identification of potential issues, both help sites avoid repeated errors, and both reduce on-site personnel costs and lessen overall site burden.

PPD FSP solutions are the clear choice for clinical operations success

Clinical operations’ use of centralized monitoring and overall dependence on statistical data makes it a prime candidate for using artificial intelligence (AI) and machine learning (ML) to accelerate and improve analysis. In a recent issue of Health and Technology (a cross-disciplinary journal addressing health care and health technology professions), one report shows that these technologies are already being used to “reduce sample sizes, improve enrollment and conduct faster, more optimized adaptive [trials].” The report goes on to suggest that significant future implications are “anticipated to improve the probability of success, reduce trial burden and overall, speed up research and regulatory approval.”

PPD™ Functional Service Partnership (FSP) Clinical Operations solutions support a range of technological innovations, including AI/ML, electronic data capture, RBQM and high levels of automation by providing specialized capabilities and enabling access to experts around the globe. As technology innovations change the roles of the clinical operations staff, our FSP teams are evolving as well, becoming specialists on everything from the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) releases to EMR quality, data collection technologies, critical thinking skills, communicating with impact and more.

PPD FSP Clinical Operations solutions also employ an evolved operating model, 360° Monitoring, that demonstrates the concept of monitoring from all angles — remotely, on-site and through centralized statistical monitoring — for a complete picture of study and site performance. As data is collected quickly (and often, automatically) and as remote data is centralized, this model delivers a combination of remote, on-site and centralized capabilities that ensure site monitoring and data review is a continual, immediate process. 360° Monitoring ensures that our PPD FSP Clinical Operations solutions teams view site performance in near real-time to accelerate resolution of findings and deviations.

As your organization seeks to optimize its use of RBQM and other technology-enabled solutions such as EMR, remote monitoring and automated data analysis, an innovative outsourcing partner is key to your success. PPD FSP Clinical Operations solutions support the delivery of the full range of technological by providing specialized resources, ready access to global talent and resource usage in cost-efficient locations — all backed by more than 30 years of experience across more than 160 countries. Our pool of talented research professionals includes more than 11,000 clinical operations professionals worldwide, across every role from clinical trial managers and clinical research associates to clinical trial coordinators, contract specialists and country approval specialists. Additionally, our centralized monitoring and risk surveillance analysis experience spans more than 10 years and more than 7,000 analysis and review cycles. Our highly rated experts are adept in the use of new technologies and are committed to the success of every trial in which we participate.