Safety reporting is a critical component of clinical trial management. As a CRO, we are able to provide a full range of safety support services. Sponsors can rely on MedTrials to augment their internal teams or to manage medical monitoring, safety data review and regulatory reporting.
Services include:
- Medical consultation: reviewing and evaluating event collection and reporting, data analysis, clinical study reports (CSRs), and regulatory submissions
- Product safety: processing serious adverse event reports including evaluation of relatedness and analysis of similar events for expedited cases; identifying and evaluating safety signals, trends, and events
- MedDRA coding
- Safety narrative development
- MedWatch reporting
- Data safety monitoring board (DSMB) coordination
- Clinical events adjudication commitee (CEC) coordination
Data Management
Through comprehensive data management solutions, MedTrials partners with you to ensure that the information generated from your data is valid, reliable, complete, and accurately reported.
Learn MoreBiostatistics
MedTrials careful biometric planning and execution promoted evidence-based solutions from valid, reliable and well-represented data.
Learn MoreSafety
Safety reporting is a critical component of clinical trial management. A partnership with MedTrials offers a full range of safety support services.
Learn MoreMedical Writing
MedTrials offers well structured and detailed writing services ranging from individual documents to extensive medical writing programs.
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