Clinical Development

Clinical research and development is complex. Finding the right partner shouldn’t be. We work hand-in-hand with our sponsors to develop strategic, flexible approaches that leverage Clinical Informatics, state-of-the-art technologies, and our global reach to maximize safety and efficiency and make data-driven decisions for every study. Our functional and therapeutic expertise spans a broad range of indications, including cardio-metabolic, oncology/hematology, infectious diseases, neurology/psychiatry, rare disease, respiratory, and biosimilars.

Risk-Based Monitoring

Optimizing studies to reduce risk and save money.

Today, drug developers face an increasingly complex and evolving landscape. Regulatory agencies are demanding smarter, more efficient risk-based methodologies to improve data quality. In addition, the increasing cost of research and adoption of EDC technologies that provide real-time access to data have forced the industry to look at optimized methods of conducting clinical studies. By employing a Risk-Based-Monitoring (RBM) approach, we can holistically evaluate each individual study and determine the right organizational structure to support both central and on-site monitoring and see data trends in real-time.

It’s no surprise that many clinical trials struggle to meet their enrollment goals. However, there’s no clinical trial without patients. Selecting the right investigative sites can significantly improve timely enrollment and the quality of data collected.

We take a data-driven approach to site selection at PRA, evaluating potential sites based on their access to the patient population, research infrastructure, past enrollment performance on similar studies, demonstrated ability to provide patient data in a timely fashion, and any potential competing clinical studies at the same site. Once evaluated, we only contact sites that are most likely to be interested in study participation and capable of meaningfully contributing to enrollment, saving you both time and money.

Clinical Trial Liaisons

Helping you get site engagement right – right from the start.

Our field-based Clinical Trial Liaisons (CTLs) can help increase participation and enrollment in your clinical trials, while also ensuring you receive high-quality data. CTLs are highly trained PhDs, PharmDs, and medical doctors with extensive experience cultivating productive relationships across all key functions of clinical research, from site selection all the way through the clinical trial. CTLs work with investigators and site staff to accurately project potential enrollment and optimize prescreening strategies, liaise with other departments to ensure data quality is maintained, and engage with non-participating physicians to generate interest in referring patients for your study.