Areas of Expertise

With more than 25 years of experience in Early Development (Phase I-IIa), Biotrial has successfully managed over 800 clinical studies for the pharmaceutical and biotechnology industry worldwide.

From technically complex trials to the more routine bioavailability/bioequivalence studies, Biotrial has the expertise and capacity to handle all types of clinical projects, including:

  • First in Human trials: Single Ascending Dose (SAD) & Multiple Ascending Dose (MAD), Combined SAD/MAD protocols including food interaction and Proof of Concept/ Bridging studies (POC)
  • Late phase regulatory studies: Bioavailability and Bioequivalence studies (BA/BE), Food-Alcohol interaction studies, Age & gender trials, TQT studies, Drug-drug interaction studies, Pharmacokinetic (PK) studies and Pharmacodynamic (PD) studies including Imaging (PET, fMRI)
  • Special Populations - Phase I Patient Cohorts, Phase II Patient Studies
  • Oncology Studies - In-house Oncologists, network of Cancer Institutes
  • CNS - Pain Models, Sleep Studies, EEG & Evoked Potentials, Cognitive Testing
  • Coagulation Evaluation - Thrombosis, Platelet Aggregation
  • Immunology - Flow Cytometry
  • Vaccines

In terms of therapeutic areas, our clinical research experience covers:

  • Allergy
  • Cardiovascular
  • CNS
  • Dermatology
  • Endocrinology - Metabolism
  • Gastroenterology
  • Hematology
  • Immunology
  • Infectious Diseases
  • Oncology
  • Respiratory
  • Rheumatology
  • Women's health
  • etc.

Recognized as a key partner in Early Development, Biotrial provides clients with high quality services bringing many years of scientific expertise and state-of-the-art facilities. Biotrial's strength lies in flawless execution of complex clinical programs with NCEs or biologics which require both safety expertise on HV and patient cohorts for early proof-of-concept.

Biotrial’s team of experts is available to assist our sponsors with the design of their Early Development plans and study-specific protocols. This includes First in Human studies as well as proof of principle, proof of mechanism and proof of concept. We apply our experience and specific know-how in various therapeutic areas to set up efficient projects enabling our partners to make early, educated, go-nogo decisions. An example of the type of consulting we can offer, applied to a specific therapy, can be found in our publication below on the Early Development of NMDA antagonists:

Publication: Development of NMDA Antagonists in Psychiatry and Pain

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