Pre-clinical/Clinical Study Management

BioClin has built strong alliances with a number of world class providers of clinical services. This allows us to seamlessly integrate our core bioanalytical capabilities with related areas of expertise; clinical study management, PK analysis and comprehensive report writing.

We have networked with selected specialist organisations in the area of pre-clinical and first-in-man. Our preferred provider for proof of concept, pilot and pivotal bioequivalence is Shandon Clinical Trials Ltd.
 
   
Klinetics™, our rapid, cost effective PK studies program enables BioClin to offer a one stop shop which optimally designs, co-ordinates, analyses and reports your pre-clinical/clinical trials to meet tight timelines and ensure compliance with global regulatory agencies.

 

Klinetics™

  • Protocol Design
  • CTA Submission
  • IMP Import / QP Release
  • Clinical Batch Stability
  • Clinical Conduct
  • Assay Validation
  • Bioanalytics
  • PK / Statistical
  • ICH Integrated Reports


Pharmacokinetics

The following services are available to maximise efficiency and ultimately ensure biostudy approval.

  • Study randomization schemes
  • Sample size and statistical power estimation
  • Blood sampling times
  • Protocol development, review and approval

A range of pharmacokinetic approaches can be applied to the biodata to maximise return from the study - types of analyses available include;

  • Bioavailability / Bioequivalence assessment
  • Non-compartmental analysis
  • Mathematical modeling and simulations
  • Convolution / deconvolution
  • In vitro in vivo correlation
  • Urinary analysis