In short

  1. In 2025, almost 1500 clinical trials in GI are planned. Of these, 112 trials focused on IBD started between January and July 2025
  2. In this crowded marketplace, the need for on-time enrollment to complete a clinical trial ahead of competitors is paramount
  3. A biopharma sponsor requested PSI take over their global, late phase trial of patients with CD and UC from an underperforming CRO – who had delayed start-up and patient recruitment by a year
  4. The sponsor initially transferred 12 countries to PSI, before transitioning the whole trial
  5. Key success factors included the sponsor’s decisiveness in transitioning to a different CRO, and the services offered by PSI: Specialist site support, thorough rescue planning, and close collaboration
  6. The sponsor was subsequently able to sign a major licensing deal with a large pharma company

The challenge

A biopharma sponsor was running a global late phase trial in UC and CD. They had every reason to succeed:

  • Their exciting drug had one of the most promising mechanisms of action on the market
  • The program design was more attractive than many other competing studies, with a separate long-term extension protocol
  • They had the right countries to complete their trial and enter the market on time and ahead of their competition

Despite this, their CRO was over a year behind schedule in start-up and enrollment – only 30% of sites were activated, and just 7 patients were enrolled.

Given the urgency required in IBD trials to beat the competition to market, the sponsor approached PSI, based on gastroenterology reputation.

GI trials: A crowded market

Over the past 10 years, approximately 10% of all clinical trials were focused on GI indications, and between 30% and 50% of these were industry-funded [1]. Within approximately 1500 GI trials planned for 2025, 112 clinical trials started within IBD between January and July 2025 (the sixth-highest number by therapy area; [2]).

The investment and interest in GI research has impacted patient recruitment – over the past 20 years, the average recruitment rates declined for patients with moderate-to-severe UC from 0.32 to 0.07 patients per site per month, and for patients with moderate-to-severe CD from 0.65 to 0.07 patients per site per month [3, 4].

In addition to the abundance of competitive trials with different therapies to choose from (including JAK inhibitors, IL-12/23 inhibitors, TL1A inhibitors, and therapies targeting IL-7R, S1PR, and adhesion molecules), other obstacles that impact patient recruitment and retention include complex protocols (thus reducing patient and site willingness to participate), narrow eligibility criteria (screen failure rates are between 50% and 70% [5]), and increased availability of efficacious, approved treatments [6]. New GI therapies can struggle in their journey to the market, and being on-time with patient recruitment is a critical factor to success.

The solution

The sponsor initiated a transition wave, moving site management, monitoring, and project management in over 10 countries to PSI. PSI’s feasibility analysis determined there were too few sites in the existing countries, therefore over 50 additional sites were added. Furthermore, PSI added additional countries to boost enrollment. Despite hesitation to transfer the entire trial in case of further delays, once PSI had delivered the initial scope in under 4 months, the sponsor made the decisive choice to completely replace the original CRO and award PSI the full scope. The sponsor transitioned the remaining countries of the trial, and all backend services, to PSI.

In parallel with the transition activities, the sponsor and PSI started implementing a plan to reinvigorate the sites and rebuild the trust in the program. A strong foundation supported the success of the program:

  • Specialist trial and site support:
    • The Project Director and Project Manager supporting the sponsor had a combined 36 years of experience in IBD, together delivering 48 phase 2 and 3 IBD protocols (including some of the largest phase 3 rescues in the industry)
    • Local CRAs not only monitor data, but provide specific, long-term support to ensure sites have everything they need to be able to recruit and retain patients – existing non-enrolling sites were turned into enrolling sites, and PSI’s additional sites were high-performing and quickly started enrollment
  • Rescue plan:
    • PSI has experience taking over studies from many CROs, including the sponsor’s original CRO, and has rescue and transition plans in place (including how to work with an incumbent CRO, and a step-wise plan for site contract transition, regulatory and IRB transition, and other important documentation)
  • Co-operatively rising to the challenge:
    • The sponsor and PSI recognized early that one of the biggest challenges for this rescue would be the transition with the clinical database. PSI’s Data Management team has the processes, and, crucially, the experience for efficient EDC rebuild and data entry

The outcome

Prior to the rescue, the sponsor’s trial was a year behind schedule. Within one year, PSI transitioned and reinvigorated the sites, completed the enrollment of nearly 300 patients, and locked the database. Based on the study results, the sponsor was able to sign a collaboration deal with a major pharma company to co-develop and co-commercialize the therapy.

PSI came in at the nick of time and threw us the CRO life line-that we desperately needed.

Global Head of Clinical Operations, Sponsor

Key takeaways

Making it to market ahead of the competition is paramount in the current IBD landscape. However, enrolling patients in IBD trials is increasingly difficult and requires a reliable partner. This case study demonstrates the positive impact of decisive action by the sponsor: Any decision on replacing an underperforming CRO should be taken as early as possible to ensure the study hits its milestones on time.

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Abbreviations

CD, Crohn’s disease;
CRA, clinical research associate;
CRO, contract research organization;
EDC, electronic data capture;
GI, gastrointestinal;
IBD, inflammatory bowel disease;
IL-7R, Interleukin 7 receptor;
IL-12/23, Interleukins 12 and 23;
IRB, institutional review boards;
JAK, Janus kinase;
S1PR, Sphingosine-1-phosphate receptor;
TL1A, Tumor necrosis factor-like ligand 1A;
UC, ulcerative colitis.

References

1. Perera, N.D., et al., Analysis of Registered Clinical Trials in Gastroenterology, 2007-2019. JAMA Network Open, 2022. 5(7): p. e2221770–e2221770.
2. GlobalData. cited 2026.
3. Harris, M.S., et al., Competition for Clinical Trials in Inflammatory Bowel Diseases. Gastroenterology, 2019. 157(6): p. 1457–1461.e2.
4. Medidata.
5. Kistler, A. Competition in Inflammatory Bowel Disease Clinical Trials. 2019 [cited 2025 August]; Available from: https://www.gastroenterologyadvisor.com/features/competition-in-inflammatory-bowel-disease-clinical-trials/.
6. Noor, N.M., Parkes, M., and Raine, T., Moving towards more patient-centred clinical trials in IBD. Nat Rev Gastroenterol Hepatol, 2021. 18(10): p. 673–674.