A data-focused clinical research organisation (CRO), Quanticate, has completed an investment initiative to upgrade its pharmacovigilance safety database and its in-house technology platform in preparation for an upcoming EU directive that will impact the pharmaceutical industry later this year.
Investment
This investment plan has been made following the European Medicines Agency’s (EMA) planned launch of an improved version of EudraVigilance — the European information system for suspected adverse events to medicines in the European Economic Area.
“As clinical data experts, we always aim to be at the forefront of compliance, hence our proactive approach to the upcoming E2B(R3) requirements and our technology investment,” explained Tom Nichols, senior director pharmacovigilance at Quanticate. “It is up to sponsors, marketing authorisation holders and clinical research organisations to make the transition and we believe our pre-emptive upgrade avoids the need for pharmaceutical organisations to use cumbersome and short-term conversion tools, which simply delay the inevitable need to upgrade later to become fully compliant.”
The company has updated its database, latest version is Argus v8.1, to offer pharmaceutical clients direct and immediate access to a fully compliant safety database without the need to invest in a unique system or use an interim solution to ensure compliance.
“Now that our enhanced database is up and running, we can provide this solution to drug developers straightaway using our web-based hosting platform before the regulations become fully mandatory,” added Nichols. “By combining regulatory knowledge with the latest digital technologies, it enables drug developers to view and access their case data in a secure and instant manner.
“The provision of an environment for a company’s in-house pharmacovigilance team also provides our clients with the ability to harness the power of industry leading software in the form of Argus v8.1 in a more cost-effective manner given Quanticate has already invested in and completed the usual set-up process.”