QUALITY ASSURANCE

CROM has an experienced Quality Assurance team comprising trained and experienced, Science post-graduates, and graduates with extensive experience in Auditing Clinical Trials, BA/BE studies and In-Vitro studies.

• Clinical Trials

• Audit support to ensure quality in all aspects during execution of clinical trials.

• Review of clinical Study Protocol and its amendments (if any)

• Review of ICF and CRF for all subjects

• Review of Clinical Study report

• Review of Method Validation protocol

• Review of Method validation data

• Review of Method Validation report

• Review of bioanalytical study protocol

• Review of subject’s sample analysis data

• Review of Bioanalytical / Analytical study report

• Release of Audit report and checking of its compliance

• BA/BE (Bioavailability & Bioequivalence) Studies

  Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of generic version to its proprietary version of a drug or formulations of innovator drug in different clinical trial phases.

• In-Vitro (IVRT And IVPT) Studies

  In Vitro permeation testing (IVPT) studies across biological membranes for formulations that are applied to the skin or in the eye are vital to guide product development and establish product bioequivalence.