Service

Our services include all the aspects of the complete clinical trial, turnkey project from concept to final report. Our Project management responsibilities include:

Conceptual Responsibilities

Study Objective Planning, Evaluating Available Data on product, Preparation of Investigator’s Brochure, Protocol drafting and finalization, CRF designing, ICF designing, translation services, Insurance consultation or liaison, GCP compliance.

Start Up Responsibilities

Regulatory Approvals (Ethics committees and FDA or DCGI as applicable), Site Selection, Due diligence, Site Training on GCP and protocol, Site Initiation, Protocol Amendments, Clinical Trial supplies management, Central and local lab appointment, Database Design and Validation.

Project management: Monitoring, Quality Control, Data Responsibilities.

Monitoring planning and communication to sites, Screening control, ICF checking, Adverse event reporting, Trial supplies management and control, Randomization, Protocol compliance, CRF compliance, Monitoring record keeping and reporting, periodic reporting, controlling and necessary action, Data collection, Data validation, Data Entry, Data Analysis, Biostatistics, Trial Supplies accountability and retrieval, Documents retrieval from sites, labs, Site Closeouts, Interim analysis and reporting if required, Financial management and control of costs at sites, labs other vendors.

Reporting

• Interim reporting(s),
• Report drafting,
• Final reporting

Other Services

• Pharmacological and toxicological studies in GLP laboratories in India
• Bioavailability studies in India
• Preparation of documents for application of marketing authorization
• Analytical services of our partner laboratory Plantachem in Germany or partner laboratory in India
• Product development by our unit
  Herbal-Care