Bioequivalence

Bioequivalence to Market Access – Backed by Nordic Expertise

  • News
  • Read time: 9 minutes

Looking for a trusted Nordic partner to deliver fast and reliable bioequivalence trials?

With over 30 years of clinical research experience, LINK Medical has provided the agility and scientific expertise necessary for successful bioequivalence trials. Our wholly owned sites in Turku and Helsinki, Finland—well known as CRST—specialize in conducting these trials.

LINK Medical has earned a strong reputation as a trusted partner in bioequivalence trials, delivering high-quality data to demonstrate therapeutic equivalence, confirm safety and efficacy, and pave the way for regulatory approval. Our work is driven by a team of experts in clinical research, pharmacology, pharmacokinetics, regulatory affairs, safety, quality assurance, and market access.

Meet Our Experts

Petri Vainio crst

Petri Vainio
Chief Scientific Officer

Petri Vainio, MD, PhD, is CRST’s Chief Scientific Officer, leading clinical development across our units. He has decades of experience as a pharmacokineticist. Before joining CRST, he was Senior Medical Officer at the Finnish Medicines Agency (FIMEA), reviewing clinical trial applications, and prior to that, he served on the national ethics committee Tukija. Petri has over 30 years of experience in clinical pharmacology in both industry and academia. In the industry, he has played key roles in advancing drug candidates from preclinical stages to late-phase clinical development and market approval. He also holds the title of Adjunct Professor of Pharmacology and Drug Development at the University of Turku.

Mika Scheinin bioequivalence

Mika Scheinin
Scientific Advisor

Mika Scheinin, MD, PhD, is our Scientific Advisor and led clinical development at CRST from its inception in 1995 until Petri’s appointment. He is Professor Emeritus of Pharmacology, with special expertise in neuropharmacology and psychopharmacology, at the University of Turku. He has been a principal investigator in over 100 clinical trials and served as Director of the Bioanalytics Laboratory at the University of Turku. Mika is well known in the Nordics and beyond for his strong scientific rigor and expertise.

Bioequivalence 2

Why Choose LINK Medical for Your Bioequivalence Trial?

  • Proven experience in bioequivalence trials – LINK Medical delivers scientifically robust clinical research services tailored to your needs, supported by experts in clinical research, bioanalytics, pharmacokinetics, regulatory affairs, safety, and biostatistics. Most of our in-house leaders in these areas have over 20 years of relevant experience.
  • Robust QMS and Regulatory Expertise – Our quality management system is fully compliant with ICH GCP E6 (R3). Combined with deep expertise in regulatory affairs, quality assurance, and safety, our team helps you navigate complex requirements, streamline submissions, and ensure data integrity throughout the trial process.

Services and Expertise:

  • End-to-end capabilities – Support from study design to clinical conduct and report writing.
  • Deep in-house expertise – Extensive experience in clinical research, bioanalytics, regulatory, safety, pharmacokinetics, and data management.
  • Flexible service model – Full-service or tailored to your project needs.
  • Broad therapeutic expertise – Covering oncology, neurology, cardiometabolic, dermatology, gastroenterology, psychiatry, immunology, and rare diseases.
  • Nordic advantage – High public trust in clinical research supports recruitment and ensures strong compliance.
  • Local regulatory expertise – One of the largest in-house regulatory teams in the Nordics, setting you up for success from the start.
  • Collaboration with bioanalytics facilities – Close partnerships with multiple labs provide optimal solutions.
  • Multichannel recruitment – Access to healthy volunteer and patient databases to support recruitment.

Reach out to explore how our expertise can support your bioequivalence trial.

bd@linkmedical.eu

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