Bioclinica preparing for ‘next wave of demand in ICSR outsourcing,’ sets company record
According to the company, the ICSR delivery team has set a company record after processing more than one million cases with a greater than 98% compliance rate for turnaround time commitments for all cases and greater than 96% quality rate across all projects.
Bioclinica President and CEO David Herron credited having the right people, technology, and processes in place to deliver compliant, on time, high-quality cases.
“We have built the necessary capability and capacity and have the flexibility to handle varying workflow and to accommodate unpredictable volumes,” he told us.
Herron said the company’s processing volume has nearly doubled since 2016 with the onboarding of new clients.
Additionally, the European Medicines Agency’s (EMA) new EudraVigilance regulations, which came into effect November 2017, recently changed reporting requirements of non-serious events in the country.
The update resulted in an immediate 15% increase in case volume, Herron said, with an additional 10-15% increase expected due to increased patient awareness.
“We’ve made preparations to help companies accommodate for these changes and meet their regulatory requirements,” he added.
In addition to the EMA and US Food and Drug Administration (FDA), which also launched a new adverse event reporting system in 2017, Herron said authorities in other regions “are waking up to pharmacovigilance needs.”
“These other authorities are not centralized and they have dissimilar processes and expectations,” he added.
“We’re looking ahead so we’re prepared to assist companies not only with the current wave but also the next wave of demand in ICSR outsourcing,” said Herron. “We’re already seeing a healthy expansion in line with our 2018 growth projections.”
