Services for Pharmaceutical Clinical Trials

Our services as pharma CRO include for example the following:

Clinical trials management

• Phase I-IV clinical trials
• Commercial & non-commercial clinical trials
• Pre-clinical trials

Clinical operations

• Clinical Trial Monitoring & Project Management
• Patients’ Cost Reimbursement
• Medical Writing / Publications
• Data Management
• Trial Master File Management
• Pharmacovigilance
• Study Plans & Documents Development
• IMP/IMD storage and Logistics coordination

Regulatory affairs 

• Study submission in accordance with 536/2014, 2017/745 & 2017/746
• Regulatory Strategy Planning
• EU Legal Representation
• Clinical Trials Insurance
• EMA Orphan Drug Designation

Site management

• Clinical Research Sites Network
• Study Sites Initiation and Training
• Study Sites Selection and Qualification
• Study Sites Payment Management
• Study Sites Contracting
• ICH-GCP trainings

Vendor management

• Vendor Selection and Qualification
• Vendor Contracting
• Vendor Oversight

Equipment rental services

• Long- and short-term medical equipment rental
• Centrifuges, freezers, refrigerators, infusion pumps, cardiomonitors, temperature loggers)