Safety and Risk Management

Aggregate Reporting and Safety Writing

Aggregate reports by safety writing experts

Aggregate reporting regulations have recently undergone a revision across the European Union. It is only a matter of time before the revisions are accepted and mandated globally to further strengthen the signal detection system and optimize the use of resources across the pharmacovigilance network for the benefit of public health.

At Sciformix, we help you to meet regulatory requirements for aggregate reporting with the help of our closely aligned scientific writing and pharmacovigilance teams, to support aggregate reporting and safety writing for all stages of the product life cycle, including summary of product characteristics, Reference safety information, Safety Update Report, Periodic Benefit-Risk Evaluation Reports among others. We have also helped customers by having our aggregate reporting team harmonize with their case processing partner to provide quality aggregate reports.

We provide complete support on aggregate reports -like SPC, ASR, RSI, PSUR, PADER and PBRER- from maintaining your global reporting calendar, to collating information from all your pertinent departments, authoring safety reports and medical review of the prepared reports, to submitting the finalized document to the regulator. Our aggregate reporting team comprises healthcare professionals and physicians who are well trained and extensively experienced across therapy areas to understand the global regulatory requirements.

Our customers repeatedly look upon us as a partner to support them on all their ad-hoc regulatory requirements such as performing an unscheduled benefit-risk assessment in response to a potential risk, to the authoring of Risk Management Plans for new license application and renewal purposes.

Resources

SRM-brochure-thumbSafety and Risk Management capabilities brochure

Sciformix’s Integrated Drug Safety solution seamlessly interweaves and synchronizes case processing (ICSR), aggregate reporting (PSUR, PADER, PBRER, ASR) and risk management across all phases of the product lifecycle. Our scientific experts aggregate and evaluate safety information from all sources, including individual cases, published safety data and competitive products to facilitate evidence-based proactive drug safety decisions.

Download information on our Safety and Risk Management services. (PDF)