Overview

Clinical Research Division offers research support for Phase II-IV clinical trials across broad therapeutic areas on a fee-for-service basis to pharmaceutical, biotech and medical device companies. Our customized solution approach offers best-in-class skills and services necessary to successfully support the clients' clinical research programs. Our highly qualified, proficient, trained and experienced staff, manage diverse clinical trials. Standard Operating Procedures (SOPs) are developed on international standards and in conformance to GCP-ICH, US FDA, Europe, Japan and India regulations to deliver all aspects of clinical project management.

Data Management

Clinical Data Management team is experienced and committed to support all functions of data validation and data management.

• We provide End-to-End Data Management services including design and data entry, data validation, query and resolution, database audit.
• Our Biostatistics practice is associated with Global CRO's who partner with us for our Quality SAS Programming Services.

Bioequivalence

As a natural extension of our Clinical service proposition, we offer a comprehensive service suite within Bioequivalence (BE) and Bioavailability (BA) studies.

Various aspects of BE/BA studies also include in-vitro assaying, impurity profiling, PK, special assays for bioanalysis, and full statistical support.

Our in house clinical facilities are well augmented with state-of-the-art instruments which include LCMS, HPLC, with UV, fluorescence, PDA and Electrochemical detectors, HPTLC system, Spectrophotometer, Electronic balances and related instruments needed for Analytical method development and execution