CRO Activities
We provide services in:
- Clinical Trials’ conduct (all major therapeutic areas);
- Medical Affairs;
- Pharmacovigilance;
- Educational Seminars.
- Clinical Feasibility Assessment
- Site Identification, Evaluation and Selection
- Scientific Consultancy
- Clinical Trial Management
- Coordination of multicenter clinical trials
- Contract Preparation and Execution
- Clinical Trial Regulatory Services
- Study Files' Preparation and Maintenance
- Administrative study support services
- Clinical Trial Monitoring
- Quality Assurance Management
- Pre Audit/Inspection corrective and preventive action plan and Audit / Inspection readiness training
- Project Management and Clinical Team Coordination
- Data Management and Biostatistics
- Site Quality Management/ Review and update of existing Standard Operating Procedures (SOPs)
- Organization of Investigators Meetings
- Concept evaluation, writing, editing and review of study documents (Clinical Trial Protocols, Informed Consent Forms, Clinical Study Reports)
- Customized CRF development
- Medical Translations
- Publications and other scientific documents
- Educational Material
- Consulting and Training
- 24/7 provision of Responsible person for pharmacovigilance
- Management and processing of safety information
- Assessment and medical review of serious adverse events
- Eudravigilance Reporting
- Development of Supportive Documentation Related to Safety Reporting
- Development of DSURs, PSURs, Line Listings
- Submissions to the Competent Authorities and Principal Investigators
- Scientific literature review
- CRA training Courses
- Clinical Research Coordinator training Courses
- Training on local Clinical research Regulations and procedures
- Training of healthcare professionals (nurses, physicians and pharmacists)