ClinSync
  • Home
  • About Us
    • Core Competencies
    • Vision and Mission
    • ClinSync Values
  • Services
    • Oncology and Special Population services
    • Early Stage Clinical Development
      • Brief Overview
      • Cardiac Safety/ TQT studies
      • Facilities in General
      • Phase I
    • Late Stage Clinical Development
      • Brief Overview
      • Data Management
      • Site Management & Monitoring
      • Program, Project & Study Management
      • Temporary Staffing/Flexible Sourcing Solutions
    • Bioanalytical Services
    • DMPK Services
    • Toxicology
    • Medical Writing
    • Biostatistics
    • Quality Assurance & Regulatory Services
    • Pharmaco Vigilance Services
  • International Operations
  • Collaborations
  • Career
  • Contact
  • Search
  • Menu

ClinSync

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

 

  • ClinSync Values
  • Core Competencies
  • Vision and Mission
Scroll to top