Services
Farzan Clinical Research will ensure that the provided services and clinical researches are performed to the highest standards, in compliance with FDA regulations and ICH-GCP guidelines and especially according to Iranian regulatory authorities – Ministry of Health and Medical Education – Food and Drug Deputy.
We are pioneer in data management of clinical research studies in Iran, managing national and international studies as a member of society for clinical data management. We use comprehensive clinical data management software with a data management protocol and clear SOP. Here is the list of our SOPs:
Farzan Clinical Research SOPs
1. Organizing A Site for Clinical Research
2. Research Team: Role Definitions, Responsibilities and Task Delegation
3. Site Research Team: Competence, Knowledge and Training
4. Preparing the team for a study
5. Protocol and Protocol Amendment, Submission to Research Ethics Board
6. Consent Process and Subject Informed Consent Form
7. Research Ethics Board (REB): Ongoing Communications
8. Subject Recruitment
9. Subject Follow-up
10. Managing Investigational Products, Biological Products, Medical Devices or Radiopharmaceuticals Under Study
11. Preparation for Monitoring Visits
12. Preparation for an Audit or Inspection Visit
13. Site Closure
14. Clinical Study Report
Frazan Monitoring SOPs
1. Monitoring a research study
2. Preparation for Monitoring Visits
The executive management team is committed to continuous quality improvement, reviewing quality objectives on a regular basis. Continuous training and testing ensures that clinical research personnel are up to date with all professionally required knowledge.
Farzan is a local contract research organization. We know the native investigators and the local regulatory process. Having a broad network of researchers in 17 major cities of the country, we are able to manage multi-center studies.
We monitor and organize clinical trials and manage the clinical sites for national and international pharmaceutical and biotech companies. We share our experience with investigators to facilitate their work. Farzan provides comprehensive product development services for bio-pharmaceutical, medical device, diagnostics and medical data industries.
We welcome cooperation with national and international pharmaceutical companies, contract research organizations and investigators.
Major categories of Services are as follow:
• Clinical Research Training
• Clinical Research
• Data Management
• Biostatistics and Research Methodology
• Medical Writing
• Regulatory Affairs
• Clinical Monitoring
• Project Management
• Research Ethics
Here is a brief overview:
• Clinical Trial Management (phases II to IV)
• RCT Protocol, Study Design, informed consent & case report form
• IRB submission
• Site identification, Management and initiation
• Monitoring of Clinical Investigation
• Conducting Multi-center Studies
• Data Management and IT Services
• Research Data Analysis
• Clinical reporting and manuscript publication
• Post-market research
• Safety Data and Adverse Event Report
• Execution of Other Research Projects
Farzan Clinical Research is certified by Ministry of Health and Medical Education- Food and Drug Deputy- Islamic Republic of Iran.