Services

Biokinetica Services

Strategic Execution

We assist our clients in executing their research and development strategies through our tailored blend of scientific, regulatory, and business expertise. Our flexible approach helps manage risk and drive superior quality and performance for each client.

Unique dual country strategy

Taking advantage of Biokinetica’s legal and operational presence in the Netherlands, located on the campus on the Academic Hospital Groningen, our services include a unique synergy, comning world class Academic medical expertse and patient access at the UMCG, with proven reliable recruitment options in Poland. The Netherlands offers an Accelerated Regulatory Pathway for Early Phase studies, allowing our clients to reach first subject-in milestones fast. This unique dual country model creates significant benefits for the overall effectiveness of our clients clinical development program, reaching go/no go decisions in a timely fashion.

In the Netherlands, Biokinetica BV collaborates with both global as well as local CRO’s and their connected Phase 1 units.

Experience

With >20 years’ experience in clinical pharmacology, Biokinetica’s leaders have broad international expertise in conducting clinical studies based on complex protocols. These include:

  • first-in-human,
  • Proof-of-Concept,
  • bioavailability and drug metabolism studies,
  • therapeutic equivalence,
  • biosimilars,
  • drug-drug interaction,
  • dose escalation,
  • QTc, and
  • CSF sampling studies.

Therefore, Biokinetica represents a unique combination of in-depth expertise in early clinical research, an experienced research team, outstanding subject housing conditions and expedited recruitment capabilities, all while maintaining the highest regard for subject safety and meeting stringent quality standards.

Service Spectrum

Together with our contracted partners, we provide comprehensive services from regulatory consulting and submission, protocol design, project management, to conducting and monitoring clinical trials through data management, biostatistics, clinical pharmacokinetic (PK), pharmacodynamic (PD) and medical writing services.

Expert Consultation

Our Early Phase Experts and Consultants Group provides protocol development consultation, safety evaluation and study results interpretation.

Clinical services

Various diagnostics

Medical services

Safety and Bioanalytical Laboratory

In house Pharmacy services and contracted GMP Manufacturing services

Quality Assurance and Quality Control

Regulatory & Ethical submission

Legal representation

Pharmacovigilance

Trial Execution Technology

Data Management

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