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  • 1 Quinta Analytica
  • 1 Quinta Analytica
  • 1 Quinta Analytica

Clinical Trials and Bioanalyses

Clinical Services at Quinta

Quinta Analytica conducts Phase I clinical trials, namely BA and BE in healthy volunteers efficiently at its dedicated ~1000 square meters clinical department comprising 64 beds in two independent units. We are capable to organize dosing sessions in large groups (up to 60 subjects in parallel). Recent FDA inspection (September 2015) revealed no findings at our clinics. An extensive database (> 6000 healthy volunteers) ensures rapid recruitment of study participants for a wide variety of PK trials.

In addition to a staff of resident and external physicians and nurses and a dedicated clinical project manager for each study, we deploy a team of specialists in bioanalytics, quality assurance, regulatory affairs and biostatistics. Accordingly, advanced equipment, skilled staff, precise material handling, and timely reporting of our bioanalytical laboratory ensure the smooth completion of projects.

Our departments and processes comply with current GCP and GLP standards, while an independent quality-assurance unit validates study data and reports. With a full range of services from study design to submission, Quinta Analytica provides everything you need to efficiently conduct your PK study.

Quinta holds a GMP license and Pharmacy license. It is capable to handle drug dispensing (including sterile solutions) and small scale primary packaging for clinical trial purposes.

In addition to own clinical units, Quinta's bioanalytical lab analyzes PK samples from many other clinical and preclinical facilities from around the world. Also our bioanalytical lab was inspected by FDA with no findings.

Appart from PK studies in oral and injection forms, Quinta currently enters a new area of expertise - PK and PD studies in orally inhalled products.

Brief overview:

PK/PD studies in healthy volunteers

PK/PD studies in patients

  • LHRH* antagonists
  • Glucose clamp studies in Russia
  • Pain models
  • Renal and hepatic impaired patients (external partner sites)

Late-phase studies in patients

  • We have good relationships with leading Czech centres in psychiatry, neurology, diabetology and oncology, capable of rapid recruitment of study participants for a wide variety of trials.

ICH E3 reporting
Project management
Import of drugs, export of plasma samples
Medical Writing, available also in Russian