Indian Scrolls
Navigation - HOME
Navigation - COMPANY
Navigation - SERVICES
Navigation - NEWS & EVENTS

Medical Affairs & Safety Management

The DiagnoSearch medical team offers you strategic and medical guidance in all the essential aspects of managing the clinical development of new products. Qualified and experienced in the clinical development process, our medical team closely collaborates with the Sponsor, Investigators and clinical project teams alike to ensure smooth conduct of every clinical trial right from development of comprehensive Feasibility Reports through full Clinical Study Reports.

At DiagnoSearch, we understand that patient safety is paramount and the protection of the well being and the rights of the trial subject is critical. Our medical and safety team strongly believes in concise and timely safety reporting with clear communication backed by appropriate medical oversight and strong medical management of every clinical trial undertaken.

Till date, DiagnoSearch Life Sciences has provided Medical Monitoring, Safety Reporting and Medical Writing and Consultation Services across phase I-IV clinical trials spanning varied therapeutic areas including Cardiovascular, Neurosciences, Endocrinology, Gastrointestinal, Hepato-biliary, Respiratory, Infectious Diseases, Immunology, Oncology and Ophthalmology.

The comprehensive range of services offered by us includes:

Medical Monitoring Services
  • Ongoing resolution of medical queries related to protocol-specific eligibility criteria, medical queries raised by the DCGI, IEC or DSMB and other protocol-related queries (e.g. dosing schedule, visit-procedures)
  • Review of protocol violations, protocol deviations, re-entry criteria, study drug discontinuation criteria and measures to avoid future protocol violations including investigator site training
  • Medical representation at Investigator Meetings (including protocol training for site teams and clarification of protocol related queries), DSMB Meetings, IND Committee Meetings and DCGI meetings
  • Medical review of safety data on an ongoing basis (laboratory /other tests) and real-time tracking of efficacy end-points as applicable

Safety Monitoring and Pharmacovigilance Services (Oracle ARGUS)
  • Investigator team training on safety reporting and clarification of safety related queries during IM
  • Development and implementation of a comprehensive and customized safety plan
  • Processing of serious adverse events (SAEs), including expedited report generation and submission to regulatory authorities and investigator sites as applicable
  • Maintaining updated safety database (Oracle ARGUS) for clinical trials
  • Support SAE reconciliation between clinical and safety databases
  • Vigilant monitoring for Adverse Events (AEs) including review of adverse events (AEs) of clinical interest, clinically significant laboratory abnormalities and adverse events leading to permanent discontinuation of the study medication
  • Review of medically coded data on adverse events and concomitant medications data

Medical Writing, Consultation and Training Services
  • Study design and clinical study protocol development (phase I-IV)
  • Development of clinical study reports per ICH-GCP (phase I-IV)
  • Compilation of Investigator Brochure per ICH-GCP
  • Medical review of clinical trial-related documents (including ICD, CRF, DVP, SAP and SAR)
  • Protocol feasibility conduct, analysis and reporting
  • Clinical development plans
  • Therapeutic area training and guidance

DiagnoSearch Life Sciences
DiagnoSearch Life Sciences