Clinical research

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Clinical trial in India

Clinical trial in IndiaWe conduct phase II and phase III human studies in India. Phase I study in India from a foreign sponsor is acceptable under certain specific conditions.

PhytoMed Service conducts clinical studies in India in collaboration with certified Indian CRO partner and takes responsibility for smooth functioning of your project avoiding wastage of time and money. Our interdisciplinary knowledge of chemistry and pharmacology of bio-active substances, our long experience in the area of herbal medicine as well as our close association with India enable us to carry out cost saving outsourcing projects. A team of experienced clinical associates and doctors carry out clinical studies according to GCP guidelines. Our ISO certified Indian CRO partner has conducted clinical trial in all major indication areas. Our team is not only qualified and competent but also takes part in GCP refreshment courses from time to time.

Procedure

A typical contract procedure starts with discussion of details and preparation of a study design. Study concept and design can be planned by sponsor. Alternatively we can propose a suitable study design, and the sponsor approves it. Under our project management our Indian or German CRO partner conducts the study in accordance with GCP guidelines. We are your contract partner and communication partner for project associated questions. We submit periodic reports and the final report.

Reason for choosing us

  • Experienced team
  • Reliable services
  • Knowledge of European regularity aspects
  • Customer oriented approach
  • ICH-CGP compliance
  • Local expertise
  • Experienced Investigators in many therapeutic areas
  • GCP trained investigators
  • Rapid access to investigational sites across India
  • Excellent recruitment speed due to large patient pool and efficient management

Services

Our services include all the aspects of the complete clinical trial (turnkey project from concept to final report).

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.

Monitoring, Quality Control, Data Responsibilities
Monitoring planning and communication to sites, Screening control, ICF checking, Adverse event reporting, Trial supplies management and control, Protocol compliance, CRF compliance, Monitoring record keeping and reporting, 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

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