Clinical Trials - Phase II to IV Studies

At Scitus, we have a vast experience of handling phase trials, and serve as a single point of contact for pharmaceutical and biopharmaceutical companies to offer a comprehensive solution for pharmacokinetic endpoint studies in healthy volunteers and patients and clinical endpoint studies in patients.

Our therapeutic areas of expertise include Oncology, Ophthalmology, Psychiatry, Vaccines & Immunology, Cardiology, Pain Management & Endocrinology.

Facility Highlights

  • We dose healthy volunteer studies in 111-bedded clinical facility
  • We have a good network of investigators and hospitals who have conducted several patient PK studies and clinical endpoint studies
  • We collaborate with partner organizations, and conduct multi-national, multi-centric clinical trials
  • We offer end-to-end services including preparation and submission of regulatory submission documents, regulatory and ethics committee approvals, clinical site identification and study execution, clinical data management, report preparation and submission to applicable regulatory agencies
  • Our team’s past experience in successfully handling regulatory inspections by agencies of highly regulated markets proves our ability to conduct quality research
  • Our unique model of project management offers dedicated project management personnel for each sponsor that allows for efficient communication among the team members as well as a single point of contact for our sponsors

Clinical Operations Expertise

Dedicated
Ambulance (24X7)

Tie up with tertiary care hospital for emergency handling

Well equipped ICU with experienced staff

Facility for Emergency Management

  • Fully equipped ICU with AE monitoring & reporting
  • Medical surveillance
  • Adequate inventory of emergency medications and equipment.
  • Nurse calling and toilet calling system
  • Investigational Product Storage Area (Pharmacy).
  • Online temperature and humidity monitored.
  • All the freezers and refrigerator are connected to a continuous Eurotherm temperature monitoring system with an alarm and Mail alert system in case of temperature excursion.

In-vitro BE Study

  • Comparative in-vitro dissolution testing
  • Phosphate binding
  • Bile acid binding
  • Bovine serum albumin binding
  • In-vitro enzyme activity studies