Bioclinica Delivers Individual Case Safety Report (ICSR) Processing with Quality and Consistency While Crossing One Million Case Milestone in 2017
Summary
“Executing a strategy that combines scientific and regulatory expertise with technology innovation, our ICSR team achieved 99 percent case submission compliance to regulators while meeting clients’ corporate expectations and international drug safety regulations,” says Bioclinica President and CEO David Herron. Additionally, Bioclinica has made investments in people and technology to handle varying workflow and to accommodate unpredictable case volumes. Dedicated ICSR and safety professionals working in multiple locations have consistently and reliably delivered compliant, on-time, high quality services. Herron explains, “Outsourcing one or more steps in ICSR case processing to our experienced team not only unburdens companies from doing it themselves but also brings added value and monetary savings across their product lifecycle. Whether Bioclinica delivers full spectrum phamacovigilance services, complete ICSR processing or selected activities, our goal is to set our clients on a successful path to meet their international drug safety reporting requirements.” With expectations of increased case volume in 2018 due to in part to the success in achieving the one million ICSR milestone with quality as well as recent changes in EudraVigilance requirements, Bioclinica has planned for significant extra capacity to meet growing demand for its ICSR services.
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