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Clinical evidence and medical device validation studies

Quint Healthcare develops clinical evidence strategies and scientifically credible studies for medical devices, diagnostic technologies and digital health. The aim is not to maximise study size, but to identify the evidence that a specific claim and decision genuinely require.

Why this matters now

European manufacturers face pressure to produce evidence that supports several decisions: regulatory compliance, reimbursement, procurement, adoption and investment. At the same time, capital and clinical capacity are limited. The relevant advantage is therefore not the largest possible study, but an evidence architecture that answers the right questions in the right sequence.

The European Commission's life-sciences strategy explicitly aims to facilitate investment in multi-country clinical trials and accelerate the translation of research into application. This creates opportunity for well-prepared projects, but also raises the standard for clinical, operational and consortium design.

The questions we answer

  • Which product claims need new clinical evidence?
  • Which audiences must the evidence satisfy: regulator, payer, clinician, procurement team, partner or investor?
  • Can existing data, literature or real-world evidence answer the question?
  • If a study is necessary, what is the smallest design that remains scientifically and operationally credible?
  • Which sites can recruit the intended population in practice?
  • How should the protocol, analysis and operational plan remain consistent across centres and countries?

Evidence strategy before study design

A good evidence strategy maps each material claim to:

  1. the decision it must support;
  2. the standard of evidence required;
  3. the data already available;
  4. the residual gap;
  5. the least burdensome credible route to close it.

This avoids commissioning a large study because it feels safe while leaving a more important claim unanswered. It also identifies when a study is not yet the appropriate next step.

What we do

Clinical investigation and validation design

Scope can include the clinical question, endpoints, comparator, inclusion and exclusion criteria, sample-size reasoning, analysis plan, assessment schedule and clinical investigation plan.

The current international standard is ISO 14155:2026, which addresses good clinical practice for the design, conduct, recording and reporting of medical-device investigations in human participants. The applicable regulatory, ethical and national requirements must also be assessed for the specific study.

Feasibility and site strategy

Clinical interest is not the same as recruitment capacity. We assess:

  • real patient flow;
  • competing studies and clinical workload;
  • investigator commitment and study-team capacity;
  • technical and data requirements;
  • the burden placed on participants and staff;
  • realistic activation and recruitment timelines.

Study project management and coordination

Clinical validation depends on more than a sound protocol. Quint Healthcare can coordinate the medical and scientific interfaces between the sponsor, principal investigator, participating centres, investigators, clinical monitors and specialist providers from initial design through analysis and medical writing.

Depending on the project, this can include:

  • defining work packages, responsibilities, timelines and decision points;
  • selecting suitable study sites internationally and assessing their operational feasibility;
  • engaging key opinion leaders and aligning investigators around the clinical question;
  • coordinating the interfaces for site contracting, monitoring, patient insurance and data management;
  • maintaining the medical and scientific exchange between sponsor, sites, investigators and clinical research associates;
  • supporting communication with ethics committees and competent authorities through the appropriate sponsor and regulatory functions;
  • organising statistical planning and analysis with qualified biostatistical partners;
  • tracking milestones, emerging risks and decisions in a transparent project structure.

This provides the sponsor with a clinically informed point of coordination while keeping regulated responsibilities and specialist tasks with the appropriately qualified parties.

Scientific and medical leadership

Quint Healthcare can lead the medical and scientific work across sponsor, sites, technical partners and service providers. Typical responsibilities include protocol decisions, medical requirements, investigator communication, work-package design, milestone review and interpretation of emerging results.

Ethics and regulatory documentation

We support the scientific rationale and clinical content for ethics and regulatory submissions, in collaboration with the sponsor's legal, regulatory and operational functions.

Analysis, reporting and publication

Work can include statistical planning with qualified biostatistical partners, clinical interpretation, study reports, manuscripts, abstracts and presentations. The communication remains consistent with the pre-specified question and the limits of the data.

Relevant experience

Documented experience includes:

  • a multicentre controlled study for a digital-health platform in high-risk pregnancy;
  • an international three-arm controlled study in chronic kidney disease;
  • a pilot study of a wearable dermal ion sensor in kidney and liver patients;
  • clinical work on a compassionate-use approach in glioblastoma;
  • scientific support for a phase 1/2 oncology study;
  • validation strategy for digital therapeutics, medical software, diagnostic assistance and sensor technologies.

The work combines clinical medicine, pathology, oncology, translational research, ICH GCP investigator training and medical-device study training.

How we work with CROs

Quint Healthcare is not positioned as a full-service CRO. The contribution is the clinical question, scientific design, medical governance and, where required, overall study-project coordination. Monitoring, data management, pharmacovigilance, insurance, statistics and site operations remain with appropriately qualified providers. Responsibilities are defined explicitly, and the providers are integrated into one coherent study structure.

A practical starting point

Evidence workshop

A focused workshop brings clinical, regulatory, product and commercial stakeholders together around the claims and decisions that matter. The output is a written evidence map showing:

  • which questions are already answered;
  • which gaps are material;
  • which study or non-study routes are proportionate;
  • the sequence, dependencies and decisions required next.