BSMA ROUND TABLE EXCHANGE: “KNOWING WHAT YOU DO NOT KNOW & PITFALLS IN CLINICAL TRIALS”

EVENT LOCATION: San Mateo Marriott San Francisco Airport, 1770 South Amphlett, San Mateo, CA, 650-653-6000

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Clinical Trials is the engine for innovation in healthcare. Bringing the hope of new medicines and medical devices to reality is the ongoing challenge of Life Sciences. Medical scientists and operations professionals carry out the development of a drug or device in a complex and disconnected ecosystem which consists of myriads of service providers and technology enablers. For majority of the start-up and mid-sized bio-pharma companies, the challenge of establishing processes, people and technology is often met organically from scientific discovery. Generally, it is learning on the job.

The objective of this Round Table is to equip the clinical operations and supply chain professionals, who are developing their first product, to integrate effectively with their internal and external customers, including service providers, CROs and technology enablers. How does one ensure that every enrolled patient receives the drug, when in 2020, 48% of trials missed them? In addition, what best practices can be learned from the experienced executives? How does one efficiently monitor clinical trials when it is reported that up to 50% of the cost of a clinical trial is monitoring? How does one effectively manage a study and perform drug accountability for the over 30% of studies that do not have IXRS? How does one complete a study in a timely manner, when about 85% of trials have been found to be delayed?