April 19, 2022
Centralizing Safety Data Management
Clinical Trial Sponsors usually select full-service CROs to handle all aspects of a clinical trial, including Safety Data Management. Some may decide to use the same CRO for all studies. However more often, due to various reasons, Sponsors will choose to work with different CROs for different clinical programs and studies while the product runs through the clinical pipeline.
From a pharmacovigilance point of view, this may eventually become an issue if not addressed timely. Just imagine having three or more safety databases within multiple CROs established for separate clinical studies and different product indications. While once having a single provider to deal with for a clinical study, your pharmacovigilance team now must manage safety data residing in multiple systems.
To avoid this, it is advisable to have Serious Adverse Events (SAEs) from all clinical trials and indications in a single safety database rather than be divided between different CRO safety databases. This can be easily achieved by centralizing safety management with dedicated pharmacovigilance (PV) service provider.
A dedicated PV service provider maintains your safety data in a single safety database. Firstly, it ensures clear sight of all information for signal detection. What is more, it enables a much smoother process for compiling data for all kinds of reports, for example, the annual Development Safety Update Report (DSUR). Besides, a single safety database and a third-party drug safety provider can bring even more advantages. Just to name a few:
- the use of a dedicated PV service provider provides a unique possibility of expedited reporting of unblinded SUSAR reports while still ensuring the protection of the blinding of the study team;
- a dedicated PV service provider can maintain a Master Safety Management Plan (Master SMP) document that will speed up the preparation and review process for individual trial SMPs;
- with a single safety database and a dedicated PV service provider, new studies can be set-up in the safety database faster;
- a dedicated PV service provider can maintain central intelligence on regulatory reporting requirements across multiple countries, which could be used for all Sponsor’s studies no matter which CROs are chosen to run the studies;
- having a single database will help avoid timely and costly safety data migrations in the future.
More and more pharmaceutical companies start to appreciate the benefits of having their PV safety data management centralized within a single drug safety service provider. If you are one of them, Insuvia’s experienced team can strategically guide you through the entire process and advise at each step. At Insuvia, we specialize in pharmacovigilance and clinical safety management services and cooperate with biopharmaceutical companies from proof-of-concept studies up to post-marketing continuous pharmacovigilance data management.
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