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