Core Competencies

Integrated Clinical Development Program Solutions

       Through the hands-on expertise and the leadership of our team, advisory board, medical experts and research analysts we will help you to align the clinical development of the molecule.

       Identification of critical issues, actions and implication through safety and competitive Intelligence, for example, competitor analysis, competitor program to treat potential recruitment etc

                - Clinical Pharmacology strategy

                - SAD and MAD studies

                - Proof of Concept strategy

                - Development strategy for each indication

                - Indications integration strategy based on regulatory strategy

                - Biomarker development strategy

                - India specific strategy ( regulatory, ethnicity etc)

                - Advisory services on post approval commitments

                - Safety and risk management strategy

 

                - Center of excellence supports execution of your Translational Medicine/Clinical Pharmacology Research programs

‘Outsource us as a package, we deliver it by ourselves or by audited partners.

Save your time. Save your money.

       Preclinical/Non-clinical Development Stage

          Animal Toxicology studies to support regulatory filing*

          Development DMPK studies to support regulatory filing*

          Regulated Bioanalysis to support animal toxicology studies

          Immunogenicity for PD and safety assessment*

          Biomarkers for animal pharmacology studies*

          PK/TK modeling

       Clinical Development Stage

          Phase 1 Healthy Volunteer studies

          Phase 2 to 4 Patient studies

          Development DMPK studies to support NDA filing

          Regulated Bioanalysis to support clinical studies

          Immunogenicity for efficacy and safety monitoring*

          PGx for patient stratification and efficacy monitoring

          Biomarkers for efficacy and safety monitoring*

          Clinical PK/PD modeling

 

 

* Actual conduct of studies in GLP environment are conducted at partner sites