Clinical Support

Once a drug candidate has reached the clinic, Accelera collaborates with the sponsor or his selected clinical CRO to support the drug development program, providing:

Clinical Bioanalysis
  • State-of-the-art LC-MS-MS instrumentation
  • Expertise in Immunoassay based methodologies
  • Rapid turnaround bioanalysis for Phase I Clinical Studies
  • Fast method development for discovery support
  • Facilities for light-sensitive and cytotoxic compounds
  • Automated sample handling
  • Biomarker assays
  • Support for special studies (human metabolism; bioequivalence; drug-drug interactions)
Clinical Parmacokinetic Analysis
Accelera offers a full range of pharmacokinetic services for Clinical pharmacokinetic analysis, including:
  • SAD and MAD studies
  • Bioequivalence/Bioavailability studies
  • Food effect studies
  • Drug-Drug interaction
  • Statistical assessment of dose proportionality, time-invariance and effect of genders
  • Special population (ie. Hepatic and renal impairment studies)
  • Population PK and PK/PD
  • Analysis and reporting of data pharmacokinetic data from Phase I/II Clinical trials.
Bioanalysis and PK services are performed and reported in accordance with GCP and relevant ICH, EMEA, and FDA guidelines and routinely audited by our Accelera Quality Group unless specified otherwise.

Validated software systems devoted to clinical services include: Phoenix-Winnonlin (Certara), NONMEM (ICON), SAS (SAS institute), Watson (Thermo Scientific) and SAS (SAS Institute, Inc.). The software are validated in accordance with requirements stipulated by regulatory bodies.