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Clinical Research & Development (CRO)

Phase I-IV & Medical Device Programs

We provide services in:

  • Clinical Trials’ conduct (all major therapeutic areas);
  • Medical Affairs;
  • Pharmacovigilance;
  • 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)