Electronic Reporting of Suspected Unexpected Serious Adverse Events (SUSARS) is now mandatory in many global territories.
SUSAR is one of the core PrimeVigilance services. We provide the facility to delegate the onerous task of registration and set up of the electronic reporting routes for the pharmacovigilance system. Experienced and EMA trained personnel ensure that expedited reporting meets the regulatory requirements in each trial territory. Whether electronic or hard copy PrimeVigilance offers consolidated expedited reporting services.
WHAT IS EXPEDITED REPORTING?
A SUSAR that meets the seriousness criteria of life threatening and/or results in death must be reported within seven (7) calendar days. A SUSAR which if not life threatening or does not result in death must be submitted to the regulatory authorities within fifteen (15) calendar days. In addition to the regulatory authorities, a SUSAR may also need to be reported to other recipients including ethics committee and investigators.
As a Sponsor, you need to be fully versed in each change to the drug safety laws around SUSAR reporting as and when it happens. Including the changes you need to introduce to remain fully compliant. With the right support you can rapidly respond to the challenges in line with your Standard Operating Procedures.
PRE-MARKETING CLINICAL TRIAL PHASES
PrimeVigilance has considerable experience advising on the submission of ICSRs for clinical trial phases 1 -3. The focus will inevitably vary from trial to trial but it should be noted that any SUSAR is subject to extremely strict deadlines for submission. PrimeVigilance can advise on when, who and how to submit and when to insert information within a Development Risk Management Plan, the Development Safety Update Reports and End of Study Reports.
Adverse reactions reported during clinical trials in the post marketing phase e.g. Post Authorisation Safety Studies (PASS) and all spontaneous reports will also need to be correctly expedited.
PrimeVigilance places particular emphasis on the timely reporting of SUSARs. With a choice of fully validated E2B compliant safety database solutions (ArisGlobal LifeSphere Safety MultiVigilanceTM and Argus Oracle health Sciences Safety) highly effective SOPs and operating guidelines, thorough employee training and a constant quality management system ‘on time’ reporting is a major priority. Reports may be made electronically or by hard copy as required by local regulations. PrimeVigilance can register and run electronic reporting systems such as EudraVigilance. Our EMEA trained employees ensure compliance with the rigorous requirements of such a system.