New RFI Templates for Pharmacovigilance
Clinical trial sponsors can now find and evaluate pharmacovigilance service providers on the Diligent Qualification Platform – July 19th, 2022
We recently added a specific Request for Information (RFI) template for Pharmacovigilance (PV) providers to the Diligent Platform to meet the requirements of global regulations and latest standards developed by the WCG Avoca Quality Consortium (AQC). This is particularly valuable for trial sponsors as it’s critical that PV providers are scrutinized against robust standards to minimize risks. These standards apply to specialist pharmacovigilance providers as well as CROs that have pharmacovigilance services as part of their offering.
The new RFI template contains sections that refer to the management of PV data, adverse event collection, case processing, signal and risk management, the PV quality system, clinical trial and post-marketing pharmacovigilance. As the AQC standards change over time, so will the RFI used by the Diligent platform, to ensure everything is compliant and up to date.
In addition to providing the RFI template, Diligent also reviews providers’ answers for completeness and relevance as they are loaded in the platform and before they are released to clinical trial sponsors. This is beneficial for both providers and sponsors: providers get an additional check to make sure that their answers are complete and valid while sponsors can rely on an extra layer of checks that saves time and effort for their teams.
Providers can join the Diligent Platform for free, allowing them to easily be quality assessed by sponsors looking to outsource PV services and thus reach pre-contract negotiations more quickly.
As the number of clinical trials in the world keeps increasing, so will the need for quality PV services in the industry in order to guarantee proper monitoring, reporting, and assessment of adverse drug reactions. The global pharmacovigilance market size was almost USD 7 billion in 2021 and is expected to expand by over 10% per year until 2030¹. With this in mind, it’s even more important for both providers and sponsors to streamline the vendor prequalification process while adhering to the latest quality standards and regulations.
Diligent now uses specialist RFI templates to cover 25 specific service areas, in addition to the core standard RFI completed by all providers on the platform. We have plans to add new templates for Mobile Biomarker Sensors and Mobile Respiratory Sensors in the next few months.
To learn more about how Diligent can accelerate your trials and help your company save time and resources, please email email@example.com
¹Market Analysis Report, Pharmacovigilance Market Size, Share & Trends Analysis Report By Product Life Cycle, By Service Provider, By Type, By Process Flow, By Therapeutic Area, By End-use, By Region, And Segment Forecasts, 2022 – 2030, https://www.grandviewresearch.com/industry-analysis/pharmacovigilance-industry
The Diligent platform will simplify and streamline your provider selection and qualification processes