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