PSI CRO approaches gastroenterology trial delivery by addressing that risk early and continuing to manage it after activation. Its GI practice combines protocol-specific feasibility with in-house medical expertise, site intelligence and hands-on operational support. The company works with nearly 6,000 participating GI sites across 60 countries, while board-certified gastroenterologists and an advisory network of 20 GI key opinion leaders contribute to study planning and execution.
The differentiator is not access to a large site network by itself. It’s the therapeutic knowledge PSI uses to determine which sites fit a particular study, and the operational closeness it maintains to help those sites perform against the timeline.
Choose Sites for the Protocol
A recognised GI centre is not automatically the right site for every gastroenterology study.
An inflammatory bowel disease programme may require investigators with access to patients previously treated with advanced therapies in a highly competitive recruitment environment. Another GI indication may face less competition but depends on sites that routinely see suitable patients and can search their databases effectively, even when those centres have less clinical-trial experience.
PSI builds feasibility around those differences rather than relying on site reputation alone.
In 2026, the company added SYNETIC, an AI-powered site intelligence platform that draws on information covering more than 500,000 institutions and three million study sites across 62 countries. The system examines historical performance and operational capability to help identify sites with stronger protocol fit before feasibility outreach begins.
Technology narrows the field, but therapeutic judgement remains important. Patient availability can change with previous treatment exposure, local standards of care or competing studies. PSI’s GI teams use those factors to determine whether a site that looks attractive on paper is realistically positioned to enrol.
The aim is to remove weak sites before they become slow sites.
Prepare Sites for the Work Behind Enrolment
Selecting the right investigator does not eliminate the operational demands of a GI protocol.
Many studies involve procedural requirements that sit outside routine patient visits. Endoscopy equipment may need qualification, imaging processes may require standardisation and site staff may need additional instruction before study procedures can be performed consistently.
PSI CRO combines therapeutic knowledge with site-level execution, helping sponsors identify where a GI protocol can realistically enrol and keeping those sites supported once the study begins.
Small operational failures matter because they rarely remain small for long. A delayed equipment qualification can hold back activation. Inconsistent procedure quality can create repeat work or uncertainty around endpoint assessment.
PSI treats those issues as part of trial delivery instead of leaving each site to resolve them independently.
The approach is particularly relevant when a protocol is unfamiliar. A site may have extensive experience treating the disease, yet still need support translating a novel trial design into day-to-day processes. Keeping operational specialists close to the study gives PSI an opportunity to address friction before it becomes a milestone problem.
Scientific complexity increasingly shapes whether a site can execute a gastroenterology study successfully.
PSI’s medical monitoring team includes board-certified gastroenterologists, supported by GI specialists on its Scientific Advisory Board. Their involvement gives operational teams access to therapeutic input when protocol assumptions or medical questions begin affecting feasibility and conduct.
That capability has become increasingly relevant in inflammatory bowel disease.
Current programmes span established designs and newer approaches involving TL1A inhibitors, combination therapies, treat-through protocols and platform structures. PSI has also worked with the first platform study design in IBD, where sites had to adjust to a structure that differed from conventional parallel-group trials.
Novel design can create development efficiency at the sponsor level while increasing complexity at the site.
Investigators need to understand how patients move through the protocol, while coordinators need processes that remain manageable as study mechanics evolve. PSI's role is to translate those scientific decisions into workable site routines without allowing novelty itself to become a source of delay.
Its 2026 GI work continues to examine issues including earlier treatment windows, personalised trial design and imaging developments, reflecting how quickly the operating assumptions behind GI studies are changing.
Recover Momentum When Enrolment Slips
The cost of weak site execution becomes most visible when a study has already lost time.
PSI’s rescue of a late-phase Crohn’s disease and ulcerative colitis programme illustrates that challenge. The sponsor transferred the study after the previous CRO had fallen approximately a year behind in start-up and patient recruitment. PSI initially assumed responsibility for 12 countries before the remaining programme transitioned.
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The strongest site network is not the one with the most recognised investigators. It is the one whose patients and operational capabilities match the protocol.
The recovery depended on more than adding recruitment activity.
PSI reassessed site performance and applied specialist site support alongside structured rescue planning and closer operational collaboration. Within a year of the transition, the study had completed enrolment of nearly 300 patients and progressed to database lock.
That experience reinforces the central value of PSI’s GI model.
An underperforming site is rarely corrected by pressure alone. The problem may be patient access, operational readiness, or how protocol requirements interact with the site’s existing workflow. Recovering the timeline requires identifying which constraint is actually limiting enrolment and changing the support around it.
Make Delivery More Predictable Across Europe
Europe offers extensive gastroenterology research capacity, but its sites do not operate as one homogeneous market.
Healthcare structures and site economics differ between countries, while local treatment practices influence which patient populations are available for a protocol. A study that performs strongly in one market may require a different site mix elsewhere.
PSI’s European base and global GI network give it a broad operating view of those differences. The company is headquartered in Zug, Switzerland, and works across major Western European research markets alongside Central and Eastern European countries. Its GI practice can combine those regional options according to the patient population and operational requirements of the study rather than spreading activity evenly across geographies.
The company reported strong delivery metrics across its wider portfolio in 2025, including planned first-patient-in performance of 95 percent and last-patient-in performance of 97 percent. Those are company-reported figures, but they provide context for PSI’s emphasis on milestone predictability.
Its gastroenterology experience gives that positioning a more specific foundation. Feasibility begins with protocol fit. Medical specialists remain connected to study conduct. Site-support teams address procedural obstacles while recruitment is active, and performance data informs where intervention is needed.
PSI CRO’s recognition as a Top Gastroenterology CRO Services provider in Europe reflects that connection between therapeutic expertise and operational execution.
Sponsors do not simply need access to GI investigators. They need sites with the patients and practical readiness to execute a particular protocol, backed by a CRO that can recognise when those conditions change.
For PSI, the objective is to turn an appropriate collection of sites into a study network that can keep delivering against the programme timeline.
