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Clinical Research
Broad Experience
Research & Development RA SA has conducted studies in all major therapeutic areas. Extensive investigator database ensure rapid study implementation across a broad range of indications. This breadth of experience ensures that we are well positioned to meet all your study requirements.
Competence and experience
Research & Development RA SA was initiated in 1993. The Company is staffed by highly experienced Clinical Research Managers (CRMs), Clinical Research Associates (CRAs) and Medical Advisers (MAs).
Offered Services
Research & Development RA SA offers professional expertise for every stage of a clinical trial.
Project Management
- Development of a specific TEAM for each project.
- Sponsor assistance with assigned management task.
- Specific Project Support.
Clinical Planning
- Protocol Development.
- Case Report Form development and design.
- Study Manual Design and production.
- Medical and safety Issues management.
- INVESTIGATORS and MONITORS meetings.
Monitoring Services
- Investigator recruitment, Site Identification and Selection.
- Investigator Contract Negotiation.
- Investigator Training.
- Pre-Study Site Visits, Site Training and Initiation Visits.
- Study Monitoring, tracking and Close Out.
- Training of Monitors and Managers.
- Data Management.
- Drug Accountability Services.
- Source Data Verification.
- Monitoring Reports in Format Acceptable to the Sponsor.
Clinical Quality Assurance and Control
- Accessible and Responsive to questions and Request for Information during any part of the study.
- Maintain an in-house Standard Operating Procedures (SOPs) that are carefully updated.
- Drug Accountability Reviews.
- Monitoring and Follow-Up of AE.
- Case Report Form Review and Data Retrieval.
- Data Privacy Protection Policy.
Site Management
- Center Files Updates.
- Source Document Verification.
- Screening Strategies.
- Enrolment Tools.
- Specific Investigator Assistance.
- Safety Monitoring.
Data Management and Statistical Analysis
- Statistical Design.
- Study Database Design.
- Data Entry.
- Data Review and Cleaning/Clarification.
- Data Processing.
- Statistical Analysis.
- Statistical Report Writing.
Medical and Regulatory Consulting
- Medical Writing.
- Final Report Writing.
- Regulatory Document Preparation and Submission.
- Regulatory Approval.
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