Sapthagiri Clintrac SMO offers the following distinct capabilities
- Network of experienced Physicians, Coordinators and study nurses
- GCP trained Investigators and Coordinators.
- Dedicated full time Clinical Research Coordinators experienced in working with Pharmaceutical Companies and Contract Research Organizations
- Access to patient pool of 800 out patients and 400 in patients maximizing patient target achievement
- Patient pre-screening to help recruitment, eDC and query management, trial master file; Quality Source documentation upkeep, Investigational Product (IP) and supplies accountability
- Maintenance of CRFs, Informed Consent Forms (ICF) and study logs
- Patient visit follow-up and compliance assistance
- Help optimize monitoring and reduce cost of poor quality data
- Support to monitoring visits and Audits and Inspections
Sapthagiri Clintrac SMO is characteristically well equipped with:
- 1000 Bedded Hospital facility &super specialty with the world class Medical infrastructure.
- 24*7 ICU facility
- Pharmacy services
- Approach to Institutional Ethics committee
- Access to patient Data Base with the positive attitude towards research
- Access to ISO 2008 certified local laboratory which is under process of NABL certification
- Latest technologies for workflow
- Infrastructure suitable for conducting trials as under:
- Study Documentation storage facility- Dedicated Cupboards with the lock and key, secured from unauthorized individuals.
- Dedicated monitoring rooms for CRO /Sponsor Representatives
- Drug Storage Area with restricted access to unauthorized Individuals
- Study documents archival facility
- Sampling area for the trial patients
- Archival facility for study documents
- Patient day care facility, dedicated patient counseling area
- Sample processing and Storage area.
A dedicated and qualified medical team of professional proficient in carrying out medical writing work:
- Development of Protocol, ICF, IB, CRF for Clinical trials and BA BE trials.
- Preparation of manuscripts, abstracts, posters, research communications etc.
- Preparation of Clinical Study Report and any other study reports.