PHARMExcel is a full service UK CRO supporting gastroenterology (GI) and inflammatory bowel disease (IBD) clinical trials. We work with biotechs, medtech companies, charities and NHS or academic sponsors to design and deliver studies that are practical for sites, acceptable for patients and robust enough to answer the questions regulators and funders will ask.
Gastroenterology & IBD clinical trials explained
Gastroenterology (GI) clinical trials cover a wide range of conditions, from Crohn’s disease and ulcerative colitis to functional bowel disorders and complex digestive or liver related diseases. These studies often involve invasive procedures such as endoscopy and colonoscopy, intensive symptom tracking and long term follow up. For patients already managing unpredictable symptoms, strict diets or complex medication regimens, participation can add a significant extra burden, so careful trial design and delivery are essential.
Why GI and IBD trials need specialist expertise
GI and IBD conditions are heterogeneous and often relapsing–remitting. Within Crohn’s disease or ulcerative colitis alone, there are multiple phenotypes, disease locations, prior treatment histories and increasing exposure to biologics and biosimilars to consider. Endpoints may combine clinical scores, endoscopic findings, histology and patient-reported outcomes, while background therapies—including originator biologics and biosimilars—must be carefully controlled and documented. This complexity flows directly into inclusion and exclusion criteria, stratification and data interpretation. Our experience includes the successful delivery of multiple biosimilar studies in Crohn’s disease and ulcerative colitis, as well as other inflammatory disorders such as rheumatoid arthritis and axial spondyloarthritis (axSpA)
Operationally, GI trials rely on endoscopy lists, specialist nursing teams, pathology labs and imaging services that are already under pressure. Scheduling study procedures around routine clinical care, bowel preparation, biopsies and follow up visits requires planning that reflects how services actually run, not just what is possible on paper. Recruitment and patient retention can be challenging, particularly in IBD, where patients may feel over approached for research or hesitant to change a recently stabilised regimen.
A CRO that understands GI and IBD trials can help sponsors anticipate these practical realities, shape protocols so they work within endoscopy and clinic capacity, and build recruitment and retention plans that recognise the daily impact of living with a GI condition.
Our experience in GI clinical research
At PHARMExcel, our operational teams have extensive experience in GI studies, with a particular focus on inflammatory bowel diseases including Crohn’s disease and ulcerative colitis. As outlined in our therapeutic areas overview, we have delivered multiple IBD trials and conducted pivotal studies in new and emerging biosimilar technologies, working closely with specialist UK centres.
Our portfolio includes the IBD Reference and Biosimilar Adalimumab Cross Over Study – iBaSS a single-centre, randomised, single-blind cross over study in patients with Crohn’s disease transitioning between originator and biosimilar adalimumab. The design and conduct of this study required close collaboration with investigators, careful management of dosing schedules and follow up, and a strong focus on patient experience during treatment transitions.
Beyond IBD, our GI and hepatology expertise is reinforced by our published work on liver disease trials, including our hepatology clinical trials article in Frontline Gastroenterology and our wider published research portfolio. This work reflects our understanding of the challenges involved in designing and delivering studies for complex liver conditions within the UK research environment.
Together, these experiences allow us to support sponsors developing new GI and liver therapies, while recognising that IBD and biosimilar development remain core areas of strength for our teams.
Examples of studies we have worked on
SWIMSUIT study
This single centre, Phase IV interventional study investigating the effects of switching from infliximab administered intravenously to infliximab administered subcutaneously in patients with inflammatory bowel disease and inflammatory arthritis.
Funder: Celltrion Healthcare
Sponsor: University Hospital Southampton NHS Trust
iBaSS study
A randomised, single- blind crossover Phase IV trial exploring the patient perspective and effectiveness of transitioning between reference adalimumab and a biosimilar with patient diagnosed with Crohn’s disease.
Funder: Biogen
Sponsor: University Hospital Southampton NHS Trust
SoCCs study
A ‘real world’ phase IV, multi-centre UK/EU observational study to understand the real-world experience of patients diagnosed with either Crohn’s Disease (CD) or Ulcerative Colitis (UC) and are receiving Amgevita.
Funder: Amgen
Sponsor: University Hospital Southampton NHS Trust
Our approach to GI and IBD studies
For each new GI study, we start by understanding the disease area, target population and current standard of care. We then work with sponsors and potential sites (UK and international) to test feasibility assumptions, review eligibility criteria and sense check visit schedules against real clinic and endoscopy capacity. That early dialogue helps to reduce the risk of avoidable amendments, slow start up or unachievable recruitment targets.
During start up, our teams support submissions to UK research ethics committees and the MHRA, tailoring documentation to the specific risk profile and procedural burden of the study. Once the trial is active, project managers and monitors keep close oversight of recruitment, protocol adherence, safety reporting and data quality, working collaboratively with sites to resolve issues quickly and pragmatically.
Because we are a smaller, flexible CRO, sponsors have direct access to the people who know their GI study in depth. Communication lines are short, and the same core team stays engaged from site selection through to database lock, providing continuity and a consistent understanding of the protocol’s nuances.
Commercially, we aim to offer clarity and choice. Sponsors can opt for full service gastroenterology CRO support or select defined services such as monitoring, safety oversight, data management or study rescue, with transparent, itemised budgets that make it easy to see how each component contributes to the overall programme.
"PHARMExcel is a pleasure to work with, always responsive and flexible. "
Professor Saul Faust (OBE), Director, NIHR Southampton Clinical Research Facility
Discuss your next gastroenterology study with our team
Whether you are planning a new IBD trial, evaluating a biosimilar in GI indications or expanding an existing programme into UK sites, PHARMExcel can help you assess feasibility, refine your protocol and plan delivery. To explore how our gastroenterology CRO services could support your next study, contact our team to arrange an initial discussion.
Gastroenterology CRO FAQs
What does a gastroenterology (GI) CRO do for sponsors?
A gastroenterology CRO provides specialist support for clinical trials evaluating drugs, advanced therapies, devices or diagnostics for GI and liver related conditions. For sponsors, this typically includes feasibility assessments, site identification, protocol review, regulatory and ethics submissions, project management, clinical monitoring, safety management and medical monitoring, data management, biostatistics, analysis and reporting.
A team with GI experience understands the specific procedures, endpoints and patient pathways involved, and can translate that knowledge into realistic study plans and reliable delivery.
In which countries does PHARMExcel run gastro clinical trials?
While headquartered in the UK, PHARMExcel has the experience and infrastructure to deliver clinical trials in Europe, USA and internationally, working seamlessly across international sites. Our team supports sponsors with country-specific regulatory pathways, site set-up and oversight to ensure consistent quality across geographies.
How do you handle endoscopy, colonoscopy and imaging in GI trials?
Endoscopy and colonoscopy are critical components of many GI and IBD trials, often alongside imaging modalities and histology. We work with sites to align study procedures with existing endoscopy workflows, including list capacity, preparation requirements and biopsy handling. Where central reading or scoring is required, we coordinate the processes for image capture, transfer and review so that they are integrated into site routines and data flows rather than added as disconnected tasks. Our aim is to ensure that endoscopic and imaging endpoints are collected consistently and to protocol, without creating unnecessary disruption for clinical teams.
How do you support recruitment and retention in IBD and other GI studies?
Recruitment and retention in GI and IBD trials can be challenging due to fluctuating disease activity, competing studies and patient concerns about invasive procedures or treatment changes. Our approach combines realistic feasibility work, careful site selection and close collaboration with investigators and research nurses. We encourage early engagement with patient pathways, clinic schedules and local IBD or GI research activity, so that recruitment plans are grounded in how services actually operate. During the trial, we monitor recruitment and retention closely and work with sites to adjust strategies where needed, always with an eye on limiting additional burden for participants.
What trial phases and study types can PHARMExcel support in gastroenterology?
We support GI and IBD studies across the clinical development life cycle, with particular strength in Phase IV, observational studies to collect real-world data, where safety oversight and patient experience are critical. Our experience includes Phase I and Phase II studies, biosimilar trials and interventional drug studies. For each study type, we adapt our monitoring, data review and safety management plans to reflect the level of risk, complexity and regulatory expectation, while maintaining a consistent focus on quality and patient safety.
Throughout the trial, we maintain clear documentation and oversight so sponsors can be confident in the integrity of their data.