Clinical Studies

MABH Solutions is providing end to end services for Clinical studies

Bioavailability (BA) and bioequivalence (BE) studies play a major role in the development of both new drug products and their generic equivalents. Worldwide Clinical Trials experts know to size the study properly to achieve sufficient statistical power; ensure that the appropriate overall design can adequately address the question at hand; standardize the environment (eg, fasting/fed, ambulatory/supine); and strictly adhere to and document Good Clinical Practices (GCP). For the smooth execution of BE studies, all such factors are deliberated in advance and included in the protocol and study plan.

MABH Solutions provides end to end services for:

  • Bio-strategy with detail technical evaluation of product and suggestion for Bio-studies with design, sample size and costing.
  • Protocol preparation/ review with respect to targeted market regulation requirement.
  • Site evaluation for clinic and bio-analytical before allotting studies.
  • Review of clinical and bio-analytical (method validation and subject sample analysis) phase of biostudy.
  • Study result review and comments on formulation modification.
  • Trouble shooting during bio-analytical phase.
  • Support to reply any regulatory query.