Independent Monitoring

Independent Monitoring (Third Party Monitoring) for Bioequivalence / Bioavailability Studies

Our specialized Team at PhaseON can offer you its experience as representing SPONSOR at the Clinical Pharmacological Units in India where you are conducting your BA/BE studies – as your representative for the Independent Monitoring and Audit of the bioequivalence studies at the CRO of your choice. This can be either – In-process Monitoring / Audit or Retrospective Audit for Clinical as well as Bioanalytical Monitoring.

Generic drug development

Generic drug development includes conducting Patient PK endpoint studies and also provide support to generic companies for the independent monitoring of the typical BA/BE studies.

Quality Assurance

Offers access to highly experienced Quality Assurance personnel to ensure compliance and quality in all clinical studies. We also provide standalone QA and audit support services to clients as needed..

Investigator Identification

PhaseOn leverages robust feasibility data and a trusted network of ICH-GCP trained KOLs and investigators across India to ensure accurate site selection across therapeutic areas.