We have the experience of using the pre-validated Aris Global safety database (ARISg™) – a world leading Pharmacovigilance and clinical safety system. This offers the functionality to report and manage adverse events for drugs, vaccines, biologicals, devices and combination products from case entry, medical review, coding via the integrated MedDRA browser, to automatic generation of submission-ready adverse event reports including CIOMS I, MedWatch 3500A and others.
This system enables us to offer customers the option to have their own specific configured database, capturing only cases from their studies, and aspects such as workflow and clinical measures can be configured to suit their requirements.
Our Pharmacovigilance team consists of safety officers (responsible for data entry, data review, narrative writing and QC of cases) and medical safety officers (responsible for medical review of a case with assessment of causal relationship to the drug or device).
Standalone service or part of a clinical trial we also undertake; pre-marketing or post marketing surveillance – we can assist you with your requirements.
An example of our processing experience for a post-marketing study included the following steps:
- Review – of the source document of a case
- Data entry and review: Creating the case in the database and entering all source document Information.
- Medical Review: Coding of adverse events according to MedDRA and narrative writing
- Quality Control: The data entered in the ARISg database are checked for completeness and consistency with the source.
Clinical Accelerator uses in-house medical experts to provide medical monitoring services in all key therapeutic areas. They are based locally in our region of operation and are available to support our investigators in the relevant time zones.
Our medical monitors have previous experience in healthcare and academic institutions and some have served as academic investigators in clinical studies. Their expertise covers many key therapeutic areas.
Along with PV services, our medical monitors also get involved in general medical consulting for the study sponsors and in site training.
Contact Clinical Accelerator for more information about how we can help with pharmacovigilance services.