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Monitoring and Study Coordinators Services
Monitoring Services
TransCom emphasizes monitoring quality and efficiency as a paramount in our clinical studies activities.
All of our CRAs are fully trained in ICH GCP requirements, standard operating procedures and project specifics to ensure best-in-class quality and speed.
Our project managers review each monitor’s activities and visit reports to ensure that the CRAs’ performances consistently meet the study’s specifications.
We perform initiation, monitoring, and close-out visits for our strategic partners in many countries.
Our flexibility in performing these activities is a significant added value for our partners and clients: we follow either client or TransCom’ SOPs, depending on our client’s requirements.
For a list of our Monitoring services please press here
• 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
• 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
Clinical Study Coordinators
Our working model incorporates a crucial piece in every successful clinical trial: a well trained, highly experienced study coordinator.
Our study coordinators are fully trained in ICH GCP requirements, standard operating procedures and project specifics to ensure best-in-class quality and speed.
They assist the Investigational site staff with performing some of the test, compiling information, dealing with queries, etc.
This allows the Investigators to concentrate on those tasks that only they can perform, providing an additional mean to reach maximum efficiency.
Whether our client’s study is conducted and managed by TransCom or not, we offer our clinical study coordinators to support our client’s efforts to bring their studies to successful completion.
Learn more about performing clinical trials with TransCom: