Clinical Trial Operations

We understand the importance of managing the accuracy and quality of data in clinical trials. 
Clinical Trial

CLINICAL TRIAL OPERATIONS:

We understand the importance of managing the accuracy and quality of data in clinical trials. We ensure clinical data accuracy and integrity by thorough review of the data, to assess the validity of outlying data points, and to carefully document query identification and resolution throughout a study’s duration. Quality assurance Unit (QAU) performs periodic operational checks to ensure trial related activities were appropriately conducted and that the data were generated, recorded, analyzed, and accurately reported according to protocol, Standard Operating Procedures (SOP), and Good Clinical Practice (GCP).

 

Monitoring & assistance for all the functions & phases for trial in India that includes:

  • Identifying, Initiating & performing monitoring at sites with feasibility studies
  • Draft study specific SOPs & Documentation
  • Protocol Planning & Development
  • Presentation of Protocol at IEC Meeting
  • Designing of Case Record Forms, Informed Consent Forms, Clinical Investigator Brochure, Patient diary & Investigator Manuals
  • Trial Registration, Regulatory Approvals including documents preparation
  • Site selection & feasibility
  • Investigators’ & Staff Training on Protocol & GCP Guideline
  • Safety Management including adverse events / serious adverse events
  • Safety monitoring supervised by medical monitor
  • Source Data Verification at sites by detailed monitoring plan and execution
  • Reporting of safety information to all stakeholders at specified time interval
  • Monitoring at site initiation, interim and close out of site
  • Negotiate and prepare contracts and budgets
  • Preparation of final study reports
  • Conducting QA Audit by trained professionals