Gastroenterology CRO Services

Specialized GI Trial Support Services

Advanced Site Selection for GI Studies

If you’re planning an IBD study, the highly competitive landscape and the need for advanced therapy-pretreated patients will define your strategy. If you’re targeting other GI indications, competition is lower, but you’ll need sites that have a regular flow of patients and can mine their databases, but may have less experience.

With over 13,000 GI sites on the planet and 6,000 actively participating in GI studies, site selection for your global study can be overwhelming. Combining 30 years of internal data with multiple public and in-licensed external data sources, PSI’s SYNETIC™ site knowledge engine captures historical performance metrics, operational capacity, and patient recruitment potential for different indications in real-time, matching high-potential sites to your protocol.

If identifying the right study geography has slowed down your enrollment in the past, PSI’s VISIONAL™ feasibility/financial planning platform will help model and compare hundreds of reliable enrollment scenarios, their budgets, and probabilities of success with your chosen preferences and constraints in mind.

Strategic Site Support

Selecting the right sites in the right countries is essential, but it’s only the first step to keeping your study on track. GI investigators are juggling heavy workloads and competing priorities, and they need a CRO that truly appreciates the pressures they face and works to ease the burden of clinical trials.

• PSI’s dedicated site support specialists work directly with CRAs to help sites overcome common roadblocks in gastroenterology trials. The team assists sites with timely activation of their endoscopy equipment qualifications and conducts regular analysis of video quality, with focused training delivered based on findings. That means fewer frustrated patients dropping out of the study, more motivated PIs, and no unexpected delays.
• With 20 gastroenterology KOLs on the PSI scientific advisory board, the sites and project teams have access to expertise from treating physicians who know what’s happening with patients right now. Our Scientific Advisory Board provides support with protocol reviews, feasibility assessments, and other medical questions to ensure your study stands out in the competitive GI landscape and you get the patients and endpoint data you need.
• To support enrollment, we set up referral networks around PSI investigator sites. Our PSI Referral Teams connect research sites and medical institutions with our experienced investigators, providing new or additional clinical trial opportunities for patients and enhancing enrollment at the sites.

Pioneering GI Therapies and Study Designs

It’s not only therapeutic products that are evolving, but also innovative study protocols, designed to speed up time to market, evaluate multiple indication applications or therapies, or prioritize efficiency and data quality. This is often uncharted territory for sites, raising questions about how this impacts day-to-day processes and increasing the potential for delays that could hinder market entry.

Through our work with the first-ever platform study design in IBD, PSI understands how to guide sites through these challenges, so your critical deadlines are met. With the right tools and training, sites aren’t just prepared but are enthusiastic about the opportunity to work on these exciting studies. This motivation translates into on-time delivery and lasting partnerships throughout your development program.