Industry Sponsored Trials:
Research Center (RC) at King Fahad Medical City (KFMC) serves as a pivot for Clinical Trials enhancement in Saudi Arabia. Therefore, we aim to establish partnerships with the pharmaceutical and biotech industry to develop and advance clinical trials (local and international), to understand the epidemiology of health-related states or events, develop preventive measures, diagnostic strategies, and therapeutic regimen and to improve the health of human being.
Liaison service to support and improve sponsored initiated studies:
• Sign Confidentiality Agreement.
• Complete feasibility questionnaire, if applicable.
• Sign the contract between KFMC - Research Center & the sponsor.
• Complete investigational drug service (IDS), if applicable.
• Communicate with Laboratory Heads (hematology, chemistry, microbiology, immunology and pathology) to get update normal ranges and accreditation certificates, if applicable.
• Fill IRB forms.
• Submission of study package including protocol, consent form (Arabic &English), investigator's brochure and investigators CV's.
• Prepare study file. (Trial Master File)
• Follow-up with IRB and Sponsored Company.
• Quality assurance for clinical research (monitoring and auditing services).
• Clinical data management.(Documents and CRF)
• Efficient study coordination, by:
1. Site setup.
2. Study subject recruitment.
3. Resource management.
Facilitate Protocol Submission to IRB, with the following documents:
• Informed consent (Arabic and English version).
• Case report form (CRF) (Arabic and English version).
• Investigator brochure.
• IRB forms, PCL form and IDS form.
• Indemnity insurance.
• Research team CVs.
• NIH, or GCP, or CITI certificate.