Passionate – Dedicated – Professional

the approach we follow

At HS346 Clinical Services, we are committed to advancing outcomes by offering a distinctive solution: a state-of-the-art clinical and ex vivo facility that produces quality results in a cost-effective and timely manner. We provide cross-functional studies that benefit R&D, clinical, and commercial sectors. We pride ourselves on having Europe’s Largest Biobank, Continually evolving and complying with ISO 20387 standards.

Clinical Studies

  • Comprehensive design and execution of clinical trials
  • Expertise in regulatory submissions and compliance
  • Data analysis and reporting that meets industry standards

Usability Studies

  • User-centered design assessments tailored to healthcare professionals and patients
  • Real-world testing to identify usability issues
  • Iterative feedback loops to enhance product design and function

Market Access Support

  • Guidance on CE marking and other regulatory pathways
  • Analysis of market trends and competitor benchmarking

Facility Highlights

  • Sample Access: Access to over 150 chronic and acute wound samples per month, providing a robust dataset for research and validation
  • Clinical Expertise: Collaboration with a wide range of clinicians for advice and lay user studies
  • Cutting-Edge Biomarker Analysis Ex vivo analysis of wound fluids to provide critical biomarker insights, supporting evidence-based decisions
  • Advanced Biobank: A cutting-edge biobank for all clinical needs

Our Biobank

Our biobank is continually evolving, with a vast range of samples available to meet clients’ needs. All samples comply with ISO 20387 standards, ensuring the competence and impartiality of biobanks. The ISCIII, our national regulatory body, ensures the quality of biological materials and compliance with operational standards. Additionally, ISCIII has championed the A2LA accreditation program for internal quality assessment to ISO 20387.

Passionate – Dedicated – Professional

Data-driven insights to support strategic planning and investment

Our testing laboratory was set up to assist in the COVID-19 pandemic, and we have expanded our scope to include other microbiological and molecular clinical test methods under our ISO 15189 compliant quality management system.

  • ISO 15189 Compliant Laboratory

  • ISO 13485 Experienced
  • ISO 20387 Biomarker Analysis

Engage | Research | Innovate

achieve your goals with purpose & strategy

Enhance product usability and drive innovation in medical solutions to ensure regulatory compliance.

Improve Patient Outcomes 

Ensure products meet the needs of users, leading to better patient care

Let’s partner to advance

Enhance Product Design

Identify usability challenges
early to optimise product functionality

Let’s partner to advance

Facilitated Regulatory Approvals 

Streamlined processes for gaining market approval

Let’s partner to advance

Speak To Our Experts +44 (0)844 588 4727 or Request A Quote

Passionate – Dedicated – Professional

Affordable Simple Pricing for Success

At HS346 Clinical, we handle projects of any size, supporting startups to large international companies.

Our affordable, simple pricing model ensures accessibility, enabling quick, evidence-based decisions with confidence. Leveraging our expertise, we design and execute fast-turnaround studies tailored to client objectives, aligned with carefully agreed clinical protocols. This streamlined approach accelerates decision-making and empowers clients to bring effective solutions to market efficiently.

Opt 1

Proof of Concept Studies

  • Small-scale investigations to validate initial hypotheses

  • 2 to 30 patients or ex vivo studies
Opt 2

Feasibility Studies

  • Larger studies assessing the viability of proceeding to more extensive research
  • 10 to 50 patients
Opt 3

Pilot Studies

  • Miniaturized versions that validate study components and protocols
  • 10 to 100 patients
Opt 4

General Performance Evaluations

  • Rigorous clinical assessments for CE-marked or existing products, stress-tested under real-world conditions

  • Collaboration with key opinion leaders (KOLs) to produce peer-reviewed publications

Opt 5

Additional Formats
— all tailored to your needs.

  • Lay user studies
  • Usability screening trials
  • Observational studies
  • Cohort analyses
  • Cross-sectional investigations

  • Full clinical trials