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The Challenge
A Cambridge-based biotech company was developing an innovative enzymatic wound gel and needed to conduct a Phase IIb randomized controlled trial to support their regulatory submission and market access strategy.
Traditional hospital sites were proving too slow and expensive. The sponsor needed:
- A GP practice with research experience and appropriate patient population
- A site capable of meeting MHRA and GCP compliance standards
- Rapid setup without compromising on quality or regulatory requirements
- Experience managing chronic wound patients in a primary care setting
- Ability to recruit and retain patients throughout the study duration
Our Solution
Clinical Research Solutions leveraged our extensive network of research-ready GP practices and our regulatory expertise to deliver a comprehensive solution:
Site Identification & Selection
We matched the sponsor with a high-performing GP practice experienced in wound care research and managing chronic wound patients. The practice had a strong track record of GCP compliance and patient recruitment.
Protocol & Regulatory Support
- Reviewed the trial protocol and provided feedback to ensure suitability for primary care delivery
- Facilitated MHRA Clinical Trial Authorisation (CTA) application
- Supported Research Ethics Committee (REC) submission
- Ensured all regulatory documentation met current standards
Site Preparation & Training
- Conducted site capability assessment
- Provided comprehensive GCP training to practice staff
- Established systems for patient identification and screening
- Set up compliant data collection and adverse event reporting procedures
Agreement Facilitation
We negotiated clear responsibilities between the sponsor and GP site, ensuring regulatory clarity and protecting both parties' interests while enabling efficient collaboration.
Ongoing Operational Support
- Developed recruitment strategies tailored to the practice's patient database
- Provided continuous site support and monitoring
- Ensured protocol adherence and data quality throughout the trial
- Facilitated communication between sponsor and site teams
Key Results
8
Weeks from first enquiry to first patient enrolled
10+
Patients recruited (study ongoing)
100%
Protocol compliance maintained
60%
Faster than traditional hospital recruitment
Why This Worked
By leveraging our network of research-ready GP practices and handling all regulatory complexity, we enabled the sponsor to launch their trial significantly faster than traditional hospital recruitment routes.
Key success factors included:
- Pre-qualified sites: Our network includes practices with existing research infrastructure and GCP training
- Regulatory expertise: We streamlined the approval process while maintaining full compliance
- Primary care focus: The trial was embedded in routine care pathways, improving recruitment and retention
- Dedicated support: Continuous operational support ensured quality and protocol adherence
- Real-world setting: Patients accessed cutting-edge treatment close to home in familiar surroundings
Impact
The practice gained valuable experience hosting complex Phase IIb trials and has expressed strong interest in future commercial collaborations. The sponsor successfully generated high-quality data in real-world primary care settings, supporting their regulatory submission timeline.
This case demonstrates our ability to accelerate medical device and pharmaceutical trials without compromising on quality, compliance, or patient safety.