We are expertise in Clinical research; provide assistance to the Sponsors, Investigators and trial sites to execute the clinical trials as per National and international guidelines and regulatory norms like ICH GCP, Indian GCP, CIOMS and as per other regulatory authorities.
We provide assistance through:
- Arrange and execute ICH GCP training program for the Investigators and study staff
- Doing feasibility for the sites
- Assistance to the site for site selection
- Preparation of site SOPs
- Preparation of SOPs for instruments handling and procedures at the site
- Prepare site for the GCP and external Audits
- Act as interactive between Sponsors and Investigator for smooth execution of trials
Providing Research co-coordinator at the site in compliance with protocol schedule of events and applicable regulatory guidelines.
- Preparation of essential trial documents like Protocol, ICF, IB, and CRF
- Preparation of case studies
- Preparation of Causilative analysis for the Adverse Events
- Preparation of manuscripts, abstracts, posters, research communications as per ICH GCP CIOMS and Indian GCP guidelines.
As it is immerging field in India we are the expertise to form the setup for the Clinical Pharmacy Department in hospitals-
- To prepare for Management of Medication for NABH and JCI audit
- To utilize the rational use of medicines
- To optimize the High Risk and high alert medicines use
- To train the Doctors ,Nurses and Pharmacist in minimizing the Medication error
- To established Batch recall procedures