Full Service CRO

• Study design and medical writing (protocol to final report)
• Conduct and monitoring of clinical trials (all phases and indications)
• Conduct of Early Phase Studies in our own Clinical Research Unit for Phase I, BA/BE, or at selected sites, with patients and healthy volunteers
• Development and validation of analytical assays
• Biostatistics, data management, web based clinical trial management systems (CTMS), EDC
• Central pharmacy (drug handling, storage, distribution and destruction)
• Independent external QA audits and co-monitoring
• GCP and regulatory training
• Consultancy in regulatory environment
• Product development strategy creation
• Meeting planning and event management
• Quality of Life Projects: translation, pilot testing, proofreading
• PIL testing