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TFS TFS HealthScience | Contract Research Organization | Global Resourcing Provider | CRO
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Quality management

Solutions Quality management

Quality you can hand over, without losing control of it.

We lead audit programmes, inspection readiness and quality oversight across your study or portfolio. Engage each service standalone or embed it alongside a clinical programme. Proactive. Risk-based. Regulatory-defensible by design.
Download our quality capabilities overview

Three ways to bring us in

Service add-on

We integrate quality services into your existing TFS-managed clinical study or programme, without starting a new contract conversation.

Standalone engagement

We take on a defined quality scope within a study or programme you run in-house or with another CRO.

Embedded quality FSP

We embed a TFS quality team directly into your function, scaling with your pipeline rather than your headcount plan.

Three services.
One quality function.

Talk to us about your quality programme

1. Audit and programme management

We lead risk-based GxP audits across vendors, sites, systems and study deliverables, focusing effort where risk is highest to strengthen oversight across the trial lifecycle.

— Qualified lead auditors

We match auditors to your scope and risk profile, applying risk-based judgement aligned with ICH E6(R3) evaluating trials and systems holistically.

—Risk-ranked findings

We deliver defensible, inspection-ready findings graded by regulatory and patient-safety impact, highlighting what requires action and where regulatory exposure sits.

— Adaptive audit programme management

We continuously reassess audit priorities as new risks, findings, inspection outcomes and operational signals emerge.

— CAPA oversight and effectiveness checks

We track findings through resolution, verify CAPA effectiveness and turn recurring issues into sustained quality improvement.

— Inspection-ready audit delivery

We connect audit delivery with portfolio-level oversight, giving you clear, regulator-defensible evidence of how risks are identified and addressed.

— Scalable audit delivery

We flex the programme as your needs evolve, with region-aware auditors and a delivery model that scales without rebuilding the engagement.

2. Inspection readiness and preparedness

We bring a study, site or sponsor team to a defensible state for FDA, EMA, MHRA and PMDA inspections on a calendar you can plan against. Our methodology mirrors regulatory inspection logic, rehearsal reflects the real thing.

The five-stage model: Engage the full model or any individual stage. Adapts to your study timeline.

— Plan: we define inspection-critical systems, key SMEs and evidence expectations, anchoring a forward-looking readiness roadmap.

— Assess and test: we test processes, documents and staff through gap assessments and graded interviews, risk-ranking findings against inspection expectations.

— Remediate: we prioritize remediation, assist clients to define CAPAs, build storyboards and coach SMEs to close gaps before inspection.

— Mock inspection: we recreate realistic inspector questioning and evidence requests to validate narratives and storylines, and provide readiness conclusions for use by the client’s executive leadership.

— Inspection support: we govern backroom coordination, request handling and follow-up throughout inspection days to closure.


Why readiness matters

— Protect approval timelines: we surface critical gaps before they trigger major regulatory questions and delay milestones.

— Reduce remediation burden: we help identify and address gaps before they become urgent, regulator-driven commitments.

— Protect data credibility: we test whether trial evidence is complete, explainable and inspection-defensible before regulatory review.

— Reduce repeat findings: we turn gaps into planned CAPAs and verify effective resolution before inspection.

3. Quality oversight and governance

We govern quality across studies and vendors through oversight aligned with ICH E6(R3) and ICH E8(R1). A single quality expert connects findings, operational data, risks and vendor performance into one clear view, so you can escalate early, make fact-based decisions and document clear action.

— Signals in. One quality view.

We integrate audit and inspection findings, non-compliances, monitoring and operational data, risks, vendor scorecards and performance data into one holistic quality view.

— Decisions out. Clear action.

We turn those signals into timely, risk-based decisions, with clear escalation and documented action.

— Secure the inspection trail.

We document how quality signals are identified, assessed, escalated and acted on, creating clear evidence of effective oversight.

—Protect quality throughout trial lifecycle.

We identify issues early, verify effective resolution, prevent repeat findings and reduce unresolved quality, safety and data-integrity risks before database lock.

How we secure your clinical pathway

Clinical continuum

Built-in flexibility, from a single CRA to full global trials.

Expert consultants, FSP and full-service clinical development, working as one team. Scale capacity across 40 countries, eliminating vendor handoffs while preserving protocol knowledge in the room the whole way through.

Therapeutic depth

Fast decisions through specialized clinical depth.

We restrict our focus to five complex therapeutic areas. Our specialized leads theyhold direct decision-making authority, fast-tracking approvals and solving site bottlenecks with scientific authority.

Teams that stay

True peers, driven by scientific urgency.

TFS holds an 88% retention rate, 8 points above the industry average. That means the senior scientific peer who joins your study is still there at database lock.

Trial security

Risk flagged early. Execution made visible.

Rooted in our Swedish heritage, we bring disciplined methodology and transparent communication to every study. We deliver real-time data integrity, flag protocol issues before they cost you time, and maintain regulatory compliance at every milestone.

Securing the path for sponsors’ science.

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Global presence designed for local agility

International scale, deep local roots

We have built our structure by integrating established clinical teams across key markets, rather than handing off trials to unknown third parties. Operating directly on the ground allows us to navigate local regulations, streamline ethics approvals and keep recruitment on track.

Australia France Hungary Italy Norway Portugal Sweden United Kingdom Belgium Czech Republic Finland Germany Israel Netherlands Poland Spain Switzerland United States Canada Denmark

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Clinical operations & outsourcing FAQs.

What clinical outsourcing models does TFS provide?
We deliver three modular frameworks under a single contract: Strategic Resourcing, Functional Service Provider (FSP), and Full-Service Trials. This model elasticity allows you to scale clinical capacity fluidly as your pipeline demands, eliminating vendor handoffs.

What is the geographic footprint and reach of TFS?
Founded in Lund, Sweden, we operate as a global CRO with active regulatory and clinical reach across 40 countries. We combine comprehensive multi-region execution with specialized infrastructure and investigator networks across Europe and the Nordics.

How does TFS maintain clinical study continuity?
We maintain an industry-leading CRA turnover rate of 14%, significantly outperforming the 20% sector average. This team stability ensures consistent protocol knowledge, reduces management burden, and protects your data integrity.

Which therapeutic areas does TFS specialize in?
We concentrate our medical, clinical, and regulatory capabilities exclusively within five core areas: Dermatology, Internal Medicine, Neuroscience, Oncology, and Ophthalmology, backed by a track record of 1,800+ completed trials.