Site Management

Capabilities

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

Facilities

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.

Medical Writing:

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.