This phase 2 randomised trial aims to assess if an experimental inhibitor reduces bowel inflammation and symptoms in adults with ulcerative colitis (UC) and Crohn’s disease (CD).

Total number of patients:
207
Sites:
172 across North America, Europe, APAC, and Australia
Adaptable supply chain:
Agile approach delivered across both purchasing and rental contracts to ensure SIV deadline compliance.
Sourcing capabilities:
Identification, sourcing, calibration and delivery of suitable equipment for 17 different international territories across three continents.
Future supply invitations:
Woodley Trial Solutions will support later stages of this study after impressing with flexibility, supply, and communication.

Across 172 different sites over a 36-month period, 207 trial participants were randomly separated into three different groups to assess the efficacy against a placebo of an experimental inhibitor for treatment of immune-mediated inflammatory diseases. This double-blind study involved participants aged 18-75 years old. It had one primary outcome measure – the percentage of participants achieving clinical remission at Week 12 based on modified Mayo Score (mMS) – and nine further secondary outcome measures. After impressing with its exceptional service, communication, regulatory knowledge, and equipment supply, Woodley Trial Solutions has been invited to supply subsequent stages of this study. 

Unmatched flexibility and service 

After agreeing a purchase contract, a change in scope of equipment provision prompted a request to switch to a rental agreement. Without hesitation, Woodley Trial Solutions prioritised the changes while ensuring no disruption to the viability of the trial or impacting its scheduled start date. Our procurement and account management team worked in close partnership to provide our client with the best possible solutions, flexibly adapting established processes to help the study team successfully navigate its changing operational landscape. This flexibility in approach and service, combined with ongoing proactivity to identify and resolve potential problems before they became significant issues, built trust and accelerated the trial’s delivery. 

Excellence in client communication 

Complete transparency at all stages, paired with consistent communication, ensured all parties were able to move forward with complete confidence. We created a guide to our warehousing and stock management processes uniquely for the client and, once the equipment had been despatched, a bespoke real-time tracker was created and updated daily. This gave the study team live status updates on orders; often short notice requests were managed with flexibility with clear lines of communication. Our guiding mission was to proactively mitigate any uncertainty, thereby enabling organisers to maintain full focus on other aspects of a hugely complex clinical trial.  

Equipment supply and calibration 

Woodley Trial Solutions’ strong stock inventory of essential laboratory and medical equipment provided a core tenet of our overall service to this study. As well as allowing for rapid calibration, it also enabled trial organisers to make plans with confidence, knowing that all supplies were on hand and ready for quick delivery worldwide. From our core stock products like 10L digital incubators, digital thermometers, and blood pressure monitors through to EZ-SmartLog™ dataloggers and other more niche equipment, we ensured suitable and regulatory-compliant equipment was delivered to site locations in three different continents on time, on budget, and on spec. In total, we supplied equipment to 98 sites in 17 different countries, including the USA, South Korea, Germany, and Switzerland. All equipment was fully calibrated to ensure patient safety and data accuracy, while our global logistics capabilities – including our Importer of Record (IoR) services – helped to achieve a seamless service from order to delivery.  

Summary 

Around the world, this trial continues to gather crucial medical information that will advance the treatment and management of UC and CD. Despite operational changes due to unforeseen circumstances, the trial has continued to meet all its scheduled deadlines – thanks in large part to the efforts, dedication, and ongoing adaptability of the dedicated team at Woodley Trial Solutions. Such was the success and appreciation of our agile approach and outstanding service, we have been invited back to supply the following stages of the trial. 

"Woodley Trial Solutions’ strong stock inventory of essential laboratory and medical equipment provided a core tenet of our overall service to this study. As well as allowing for rapid calibration, it also enabled trial organisers to make plans with confidence, knowing that all supplies were on hand and ready for quick delivery worldwide."
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