CRO Activities

We provide services in a) Clinical Trials’ conduct (all major therapeutic areas), b) Medical Affairs, c) Pharmacovigilance as well as d) Educational Seminars.

Clinical Operations

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

Medical Affairs

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

Pharmacovigilance

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

Training Workshops & Seminars

CRA training Courses
Clinical Research Coordinator training Courses
Training on local Clinical research Regulations and procedures
Training of healthcare professionals (nurses, physicians and pharmacists)