Clinical Trials Services

TransCom emphasizes Clinical Research quality and efficiency as a paramount in our clinical studies activities.

All our CRAs are fully trained in ICH GCP requirements, standard operating procedures and project specifics to ensure best-in-class quality and speed. We support and supervise our CRAs with senior mentors at the sites and at the office. Our senior personnel have more than 6 years' experience as CRAs and Senior CRAs, to ensure they understand the implications of the monitoring activities at sites.
 
During the study, our project managers review each monitor's activities and visit reports to ensure that the CRAs' performances consistently meet the study's specifications.
 
Our Monitoring services include:

• Study feasibility
• Pre-study selection visits
• Investigator and Site selection
• Preparation and submission of regulatory files
• Negotiation of study budget and agreements
• Investigators Meeting Coordination
• Site initiation training and ongoing training of staff
• Investigational Site management
• Investigational Site monitoring
• Full logistics of study materials, including study medication
• Full financial services / contracting
• Investigational Product import, accountability and destruction
• Submission of SAEs, Interim and Final Study reports
• Overall quality control and reporting