Clinical & Pre-Clinical Studies

Qsite provides a range of pre-clinical and clinical study services. We have vast experience in designing pre-clinical and clinical studies in compliance with regulatory requirements (ICH/GCP, ISO 14155-1 and ISO 14155-2). We can calculate the appropriate sample size, design your study and produce all study-related paperwork, develop and manage the study database, perform study monitoring and write study interim and final reports - including statistical analysis.

Key Clinical Services:

Study Design:

  • Protocol design and writing
  • Case report form (CRF) design and production
  • Submission to and liaison with Ethic Committees/IRB and MOHs
  • Preparation of Investigator Brochure (IB)
  • Writing Inform Consent Form (ICF)

Study regulatory services:

  • Preparing all necessary site files
  • Writing clinical study procedures (SOP's)

Study monitoring services:

  • Site evaluation and qualification
  • Performing initiation visit
  • Routine monitoring throughout the study

Data management:

  • Database development and management
  • Data entry

Statistical services:

  • Biostatistical consultation
  • Sample size calculation
  • Data analysis
  • SAS programming

Study reports:

  • Periodic study status reports
  • Interim and final reporting
  • Scientific writing for publication

Turning your product into reality