Quanticate has completed an investment initiative to upgrade its pharmacovigilance safety database and its in-house technology platform in preparation for the upcoming Article 2(3) of Directive 2010/84/EU that will impact the pharmaceutical industry later this year.
The data-focused clinical research organization (CRO) has made the move 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, on November 22, 2017. The new system will simplify adverse event reporting in the EU and enhance data availability to stakeholders for improved signal detection activities.
The capability expansion enables Quanticate to offer pharmaceutical clients direct and immediate access to a fully compliant safety database without them needing to invest in their own system or use an interim solution to ensure compliance.
Tom Nichols, senior director pharmacovigilance at Quanticate explains: “As clinical data experts, we always aim to be at the forefront of compliance, hence our proactive onboarding of the upcoming E2B(R3) requirements and our technology investment.
“It is up to sponsors, marketing authorization holders and clinical research organizations to make the transition and we believe our preemptive upgrade avoids the need for pharmaceutical organizations to use cumbersome and short-term conversion tools, which simply delay the inevitable need to upgrade later to become fully compliant.
“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 Mr Nichols.
Quanticate’s decision to update to the latest version of Argus v8,1 has been taken to reinforce the niche CRO’s position beyond typical pharmacovigilance service offerings as the company also supports small to large sized pharmaceutical companies with pharmacovigilance safety database hosting technology as a service.
Mr Nichols continues: “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.”