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Clinical Trial Drug Safety

Case Processing and Submissions

What is it?

Sponsors of clinical trials and marketing authorisation holders of medicinal products must legally capture, process and submit adverse events that occur with their products. This includes the databasing of serious adverse events (SAE) and expedited reporting of suspected, unexpected serious adverse reactions (SUSAR) to regulatory authorities and agencies. The processing should be efficient, effective and allow for the assessment in change in frequencies, severity or seriousness of these adverse events.

How we can help

We provide support across the full span of single case processing, including triage, medical review, quality review, Responsible Person for EudraVigilance allocation and expedited and periodic reporting.

Our timely, thorough, and accurate processing and reporting of adverse events are among the most important services that we provide. As a combined entity, we have been providing clinical trial safety services since 1992. During this time, our pharmacovigilance group has grown to include over 1,000-experienced safety associates globally.

Our centralised team within pharmacovigilance maintains our regulatory intelligence information in coordination with our local teams around the globe. The centralised submissions associates perform submissions to health authorities, ethics committees and Safety Alert Letters (SAL) to investigative sites, and track regulatory compliance metrics for all safety reporting.

We employ the use of Oracle Argus Safety database as our global comprehensive solution for product safety monitoring and compliance. Argus functionality supports the pharmacovigilance regulatory/industry requirements with the ability to produce international expedited and periodic reports.

Safety Data Report Writing (DSUR) 

What is it?

Periodic analysis of aggregated safety data is an important part of both the clinical development of a medicinal product and for the ongoing maintenance of drugs with marketing authorisations. These reports summarise the assessment of any new safety issues that could affect patient safety. It also provide the status of a clinical programme or marketed drugs alongside their risk-benefit profile.

How we can help

Kinapse offers safety report writing services for Development Safety Update Reports (DSUR).

The Kinapse team has a successful record of accomplishment in authoring aggregate safety reports for a wide variety of biopharmaceutical and gene therapy customers. We provide a flexible and customised end-to-end writing, benefit-risk assessment as well as management of report preparation and coordination of stakeholder contributions, including submission.

We have a dedicated team of aggregate report writers and drug safety physicians exclusively working on report writing programmes. Our team is experienced in writing all reports in accordance with the relevant regulatory requirements (e.g. ICH E2F). They provide benefit-risk assessment and medical review preparing safety evaluation reports if required, authoring of characterisation of risks, and providing strategy support. We act as a partner adapting to your evolving needs. This allows us to provide a flexible solution to aggregate safety report writing.

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We share our client’s commitment to achieving successful patient outcomes whilst ensuring patient safety. Our market leading integrated services support all your pre and post approval activities.
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Post Authorisation Pharmacovigilance

  • Pharmacovigilance System Management
  • Risk Management Plans (RMP)
  • Safety Data Report Writing (PSUR/PBRER, PADER)
  • Literature Services
  • Signal Detection
  • Adverse Event Processing and Expedited Submissions
  • Independent Quality Control
  • Safety Call Centre

Database Support

  • Identification of Medicinal Products (IDMP)
  • Substance, Product, Organisation and Referential (SPOR)
  • EudraVigilance
  • Extended EudraVigilance Medicinal Product Dictionary (xEVMPD)