Clinical Development

From first human dose to real-world patients.

From Phase I–IV trials to bioequivalence (BA/BE) studies, Caco-2 permeability, IVRT, and IVPT, we deliver full-service clinical execution with GCP monitoring and data integrity audits.

 

Protocol Development & Biostatistics Plan

Scientifically robust, regulatory-ready protocols.

Site Feasibility & Investigator Selection

Global clinical trial network.

Ethics & Regulatory Approvals

IEC/IRB and health authority submissions.

BA/BE Studies

Including specialised permeability (Caco-2), IVRT, IVPT.

Phase I–IV Clinical Trials

From FIH to post-marketing.

Clinical Trial Monitoring & Auditing

GCP compliance, data integrity checks.

Data Management & Statistical Analysis

EDC setup, data cleaning, statistical interpretation.