Total Management Service of Phase II and IV Clinical Studies

TransCom's Clinical Operations Department specializes in clinical trials management services in compliance with the ICH-GCP guidelines for Phase II-IV clinical trials, managing the client's specific requirements for both small- and medium-sized clinical trials.

Our ICH-GCP compliant service offerings include: 

• Feasibility studies
• Pre-study site selection for sites and investigators
• Essential document QA checks and retrievals
• Contracts and budget negotiation
• Adaptation of submission documents to local regulations
• Submission of studies to local IRBs and regulatory authorities
• On-site initial and ongoing training
• All study-specific logistics at a national level
• Site management and monitoring
• Pharmacovigilance-related activities
• Data cleaning and retrieval
• Ongoing communication with local IRBs and local regulatory authorities (when required)
• Close-out visits and study closure
• Handling of audits and inspections at a national level
• Archiving of local study-related documentation

In addition, we provide consulting services for the medical writing of protocols, Informed Consent Forms, CRFs, SOPs, etc.

With our extensive experience and infrastructure, we are able to tailor a management and monitoring suite for budget optimized, successful clinical trials