Clinical Research Excellence

Clinician-Led Medical Device CRO — More Than the Standard CRO

We combine clinical expertise, pragmatic trial design and regulatory partnerships to deliver studies aligned with real patient pathways.

Cyber Essentials Plus Certified
MHRA Approved
GCP Compliant
MDR Aligned
Clinical Research Solutions Hero Image

Welcome from Liz Hawes

Discover how Clinical Research Solutions can accelerate your medical device innovation with our clinician-led approach.

2-8 week setup
+ NHS-integrated
7M ~7M patient network

Built on Trust & Excellence

Our certifications ensure your trials meet the highest standards of quality, security and regulatory compliance.

Cyber Essentials Plus

Government-backed cybersecurity certification ensuring your data is protected to the highest standards.

MHRA Approved

Recognised by the UK's Medicines and Healthcare products Regulatory Agency for clinical trial delivery.

GCP Compliant

Fully compliant with Good Clinical Practice standards, ensuring ethical and scientific quality.

MDR Aligned

Expert understanding of Medical Device Regulation requirements for successful market access.

Evidence That Powers Market Access

We don't just run trials—we design them around real clinical workflows, regulatory requirements and commercial realities.

1

NHS-Integrated Research Network

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.

  • Experienced research-ready GPs
  • Rapid ethical and site approvals
  • Studies embedded in routine care pathways
2

Clinician-Led Design

Our team includes practising GPs and nurses who understand how medical devices are actually used in clinical settings.

  • Protocols designed around real patient journeys
  • Endpoints aligned with clinical decision-making
  • Practical insights into device usability and adoption
3

Speed Without Compromise

We're structured to move quickly—from protocol to first patient in 2-8 weeks—without sacrificing quality.

  • Streamlined regulatory approvals
  • Pre-engaged research sites ready to start
  • Agile study design and amendments
🎯

Pragmatic Trial Expertise

We specialise in real-world evidence studies that answer commercial questions and support regulatory submissions.

  • Service evaluations and feasibility studies
  • Post-market surveillance
  • PMCF studies for MDR compliance
🔍

End-to-End Support

From initial concept through to regulatory submission, we manage every aspect of your clinical programme.

  • Protocol development and ethics applications
  • Site management and patient recruitment
  • Data analysis and reporting for MHRA/Notified Bodies
💡

Commercial Focus

We understand the business case behind each study and design research that delivers the evidence you need for investors, payers and regulators.

  • Evidence aligned with reimbursement requirements
  • Data packages tailored for market access
  • Health economic endpoints where appropriate

Comprehensive Clinical Trial Solutions

Full-service support from concept to completion—tailored to medical device innovators.

1

Clinical Trials & Service Evaluations

Regulatory-compliant studies designed to generate the evidence you need for market access and device certification.

  • First-in-human and early feasibility studies
  • Pivotal trials for CE/UKCA marking
  • Real-world service evaluations
  • Post-market clinical follow-up (PMCF)
  • Comparative effectiveness studies
2

Protocol Development & Ethics

Expert protocol design and regulatory submissions that balance scientific rigor with pragmatic delivery.

  • Study design consultation
  • Protocol writing and review
  • REC and HRA applications
  • IRAS and MHRA submissions
  • Site feasibility and selection
3

Patient Recruitment & Site Management

Rapid recruitment through our extensive network of research-active primary care sites.

  • Access to ~7M patients via PCRA network
  • Targeted patient identification
  • Site initiation and training
  • Ongoing site monitoring and support
  • Retention strategies and follow-up
4

Data Management & Analysis

Secure, GCP-compliant data systems with expert statistical analysis and regulatory reporting.

  • eCRF design and database setup
  • Real-time data monitoring
  • Statistical analysis plans
  • Final study reports for regulators
  • Publications and dissemination support
5

Quality & Regulatory Compliance

Full QA oversight ensuring your study meets all regulatory requirements and quality standards.

  • Clinical study training
  • Trial Master File management
  • Site monitoring and audits
  • Safety reporting (SAE/SUSAR)
  • Regulatory inspection readiness
6

Strategic Consulting

Expert advice on clinical development pathways, regulatory strategy and evidence requirements.

  • Clinical development planning
  • Regulatory pathway advice (MHRA, Notified Bodies)
  • Health economics and reimbursement strategy
  • Literature reviews and gap analysis
  • Due diligence for investors

Clinical Expertise Meets Research Excellence

Led by practising clinicians with deep experience in medical device trials and regulatory affairs.

Liz

Liz

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.

Steve

Steve

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.

Daphne

Daphne

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.

Chi

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.

Aaron

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.

Abbie

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.

Olga

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.

Rachel

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.

Richard

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.

Trusted by Medical Device Innovators

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."

— David Fairlamb, COO SolasCure

"Working with Clinical Research Solutions has been a really positive experience. They've provided clear, practical support and worked collaboratively with us throughout."

— Dr Anuj Chahal, Senior Research GP

"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."

— Mr Guglielmo Piozzi, Clinical Research Fellow & Surgeon, Portsmouth Hospitals University NHS Trust

"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."

— Medical Device Company

"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."

— SME Client

"All members of the team have been responsive to our needs and requests and seem to clearly understand our commercial business needs."

— Biotech Company

"I would see this as excellent value for money given the speed of recruitment and the positive outcome."

— Clinical Trial Sponsor

"From protocol development and regulatory submissions to site management and data integrity, their hands-on support has been instrumental in streamlining trial delivery."

— Research Site

"Their direct engagement and strong collaborative approach have helped ensure compliance and high-quality outcomes throughout our study."

— MedTech Company

Let's Accelerate Your Innovation

Tell us about your device, timelines and endpoints. We'll respond with a practical route to evidence generation and delivery.

Book a Consultation

Get in Touch

Ready to discuss your medical device trial? Contact our team to explore how we can support your study.

Call Us

01903 331828

Office Hours

Monday - Friday, 9am - 5pm GMT