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Clinical Trial Management

Department of Clinical Trials at CHARAKA CLINICAL AND TRANSLATIONAL SCIENCES PVT LTD offers full drug development services. We specialize in strategic development, management, execution, and analysis of all Phase II to Phase IV clinical studies of herbal drugs and other alternative medicines. This department is all set to efficiently, and ethically scientifically execute clinical research programs to promote better medical care for the whole of mankind.

The mission of this department is to help herbal companies and research institutions worldwide in conducting high-quality clinical research trials globally with an emphasis on reducing clinical trial timelines and costs by applying deep therapeutic expertise. We give utmost importance to patient rights, and safety and also ensure all required confidentialities

Services Offered

Pre-Clinical Studies

  • Stability Study
  • Animal/ Toxicity Study

Clinical Trial Budgeting

  • Overall budget
  • Site budget
  • Regulatory costs
  • Allocate for safety costs
  • Costs for data and quality management
  • Other overhead costs
  • Site costs

Medical
Writing

  • Preparation of Protocol
  • Investigator Brochure (IB) or Product Dossier
  • Case Report Forms (CRFs)
  • Informed consent form (ICF)
  • Subject Diaries
  • Study logs (delegation log, IP logs etc.)

Regulatory Submissions

  • DCGI Submissions
  • EC submissions
  • CTRI (Clinical Trials Registry- India) Registration

Clinical Operations

  • Site selection& Site management
  • Trial Management
  • IP and Trial Material Management
  • Data Management
  • Monitoring
  • Clinical Study Report

Documentation Services

  • Documentation of clinical trial ( TMF, PMF, SMF )
  • Quality System Management
  • Case Report Forms (CRFs)
  • SOP Development
  • Literature Review Dossier
  • Common Technical Documents
  • Drug Master file

Biostatistic Services

  • Preparation of Study Design
  • Determination of sample size based on power analysis
  • Interim Analysis
  • Final Analysis & Report

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