Clinical Trial Safety

Real Time Trials’ pharmacovigilance personnel can manage all of your clinical trial safety requirements (Lifecycle Safety concept), including the following:


Writing the safety section of the trial protocol;

Design of Case Record Forms (CRF), also in electronic format - eCRF - and Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting forms;

Provision of a central point of contact for reporting of SAEs;


Training the clinical trial staff and investigator site staff on pharmacovigilance requirements;

Case receipt, triage, MedDRA coding, data control and entry, narrative writing, literature review, quality assurance and reporting of cases to agencies;

Automated production of line listings for signal detection, trend analysis and risk management;

Writing of FDA-conform annual reports and annual safety reports (EU);

Registration of your companies with EudraVigilance;


Electronic reporting to EudraVigilance clinical trial module using an well-established gateway;

Provision of qualified person for pharmacovigilance (QPPV) / responsible person for EudraVigilance (RPEV);


Preparation of safety sections of Investigator Brochure;


Safety review and sign off on final clinical study reports;

Set-up of, management and participation in Data Safety Monitoring Boards (DSMBs);

Design of our own or utilisation of existing in-house SOPs.