We combine clinical expertise, pragmatic trial design and regulatory partnerships to deliver studies aligned with real patient pathways.
Discover how Clinical Research Solutions can accelerate your medical device innovation with our clinician-led approach.
Our certifications ensure your trials meet the highest standards of quality, security and regulatory compliance.
Government-backed cybersecurity certification ensuring your data is protected to the highest standards.
Recognised by the UK's Medicines and Healthcare products Regulatory Agency for clinical trial delivery.
Fully compliant with Good Clinical Practice standards, ensuring ethical and scientific quality.
Expert understanding of Medical Device Regulation requirements for successful market access.
We don't just run trials—we design them around real clinical workflows, regulatory requirements and commercial realities.
Direct access to ~7 million patients across primary care and secondary care through the Primary Care Research Alliance (PCRA) and our hospital network—the UK's largest GP-led research network.
Our team includes practising GPs and nurses who understand how medical devices are actually used in clinical settings.
We're structured to move quickly—from protocol to first patient in 2-8 weeks—without sacrificing quality.
We specialise in real-world evidence studies that answer commercial questions and support regulatory submissions.
From initial concept through to regulatory submission, we manage every aspect of your clinical programme.
We understand the business case behind each study and design research that delivers the evidence you need for investors, payers and regulators.
Full-service support from concept to completion—tailored to medical device innovators.
Regulatory-compliant studies designed to generate the evidence you need for market access and device certification.
Expert protocol design and regulatory submissions that balance scientific rigor with pragmatic delivery.
Rapid recruitment through our extensive network of research-active primary care sites.
Secure, GCP-compliant data systems with expert statistical analysis and regulatory reporting.
Full QA oversight ensuring your study meets all regulatory requirements and quality standards.
Expert advice on clinical development pathways, regulatory strategy and evidence requirements.
Led by practising clinicians with deep experience in medical device trials and regulatory affairs.
CEO
Research nurse with extensive experience in clinical trials and patient-centered care. Leads the company's strategic direction and ensures all studies maintain the highest standards of quality and patient safety.
CFO
Experienced life sciences CFO with deep expertise in financial strategy and operations management. Brings extensive commercial and operational leadership to support the company's growth and clinical trial delivery.
Medical Director & Chief Investigator
NHS GP with 20 years of experience in the NHS. Specialist in primary care research, pragmatic trial design, and regulatory compliance. Ensures trial protocols are practical and clinically relevant.
Senior Project Manager
Leads the delivery of complex multi-site clinical trials from protocol development through to final reporting. With extensive experience in pharmaceutical and medical device studies, Chi ensures projects stay on track, on budget, and meet all regulatory milestones. Expert in stakeholder management, risk mitigation, and coordinating cross-functional teams to deliver high-quality research outcomes.
Quality & Compliance Manager
GCP and regulatory compliance expert. Manages TMF, safety reporting and audit readiness. Ensures all studies meet MHRA and MDR requirements. Background in pharmaceutical quality assurance.
Data Manager & Statistician
Experienced data scientist specialising in clinical trial data management. Expert in eCRF design, database validation and statistical analysis. Ensures data integrity and regulatory compliance throughout studies.
IRAS & Regulatory Submissions Specialist
Over 20 years of experience in clinical research and regulatory affairs. Expert in IRAS applications, ethics submissions, and navigating complex regulatory pathways. Ensures streamlined approvals and maintains excellent relationships with regulatory bodies including HRA and MHRA.
Administrative Manager
Ensures smooth day-to-day operations across all our clinical trials. Coordinates communications, manages documentation workflows, and provides essential administrative support to the research team. Her organisational skills keep projects running efficiently from initiation through to completion.
Data Protection Officer (DPO)
Oversees all data protection and privacy compliance across our clinical programmes. Ensures adherence to UK GDPR, manages data processing agreements, and maintains robust information governance frameworks. Works closely with research teams to safeguard participant data and maintain the highest standards of confidentiality.
Hear from the companies and clinicians we've supported through successful trials.
"Their expertise in community based wound care, combined with flexibility and dedication to the study were instrumental in maintaining the highest standards of clinical quality throughout the trial."
"Working with Clinical Research Solutions has been a really positive experience. They've provided clear, practical support and worked collaboratively with us throughout."
"Clinical Research Solutions has been an exceptional partner in supporting our MHRA-regulated trials within Portsmouth Hospitals University NHS Trust. Their team's professionalism, responsiveness, and in-depth knowledge of clinical trial governance have been invaluable at every stage."
"For a relatively small amount of money, this study has shaped technology improvements, protocol refinements, and elucidated unexpected product benefits that we can hone in on during further development."
"We discussed a first draft protocol with the team in April, finalised an agreement in May and were into live phase with patients by June."
"All members of the team have been responsive to our needs and requests and seem to clearly understand our commercial business needs."
"I would see this as excellent value for money given the speed of recruitment and the positive outcome."
"From protocol development and regulatory submissions to site management and data integrity, their hands-on support has been instrumental in streamlining trial delivery."
"Their direct engagement and strong collaborative approach have helped ensure compliance and high-quality outcomes throughout our study."
Tell us about your device, timelines and endpoints. We'll respond with a practical route to evidence generation and delivery.
Book a ConsultationReady to discuss your medical device trial? Contact our team to explore how we can support your study.
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