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FDA leader discusses breaking barriers in clinical care Acting FDA commissioner Janet Woodcock explains how government, researchers, doctors and patients can contribute to improving the clinical research system. With more than three decades of experience at the US Food and Drug Administration (FDA), acting commissioner Janet Woodcock has an informed perspective of the government’s contributions to pharmaceutical development, drug safety, and clinical research. She’s seen the agency work closely with the National Institutes of Health, she said, and witnessed “...

BBK Worldwide launches patient-centric trial resource With the Engagement Solution Center, the patient-recruitment services specialist is aiming to improve the patient-centricity and inclusivity of studies. BBK Worldwide has announced the creation of its Engagement Solution Center, a new resource designed to centralize design, management, operations, and communications of various patient-visit support services. The center is geared toward easing the burden of research for rare and orphan diseases in addition to larger and Phase IV/V studies. Outsourcing-Pharma disc...

Starting studies right can ensure a stronger finish: Oracle A leader from the clinical trial technology firm suggests ways to design research from the start to help accelerate studies and avoid stumbling blocks. While clinical trials have made a number of advancements in decentralized design, data processing, and other aspects, one area remains a pervasive challenge: startup time. Outsourcing-Pharma recently spoke with Jae Chung, vice president of product management and strategy with Oracle Health Sciences, about solutions to optimize the process, and to increase o...

Drug development advancements call for skilled workforce According to a leader from Saama Technologies, keeping competitive in the face of technology evolution requires staff that can keep up with the changes. Suresh Katta, CEO and founder of Saama Technologies, spoke with Outsourcing-Pharma about the rapid technological advancements in the drug development field, and how companies can cultivate a workforce capable of keeping up. OSP: Could you please talk about some of the shifts in and demands on the clinical trial industry that are changing what we expect of st...