Incorporating risk management into studies is challenging, but important to meet standards. Jill Cernohous, Senior Clinical Principal Advisor Considering Risk ICH E6(R2) requires sponsors to implement a system to manage quality throughout all stages of a clinical study. This process should be based on study activities that could have the greatest impact on human subject protection and the reliability of study results (or highest risks), and goes beyond risk-based monitoring. Making it work To achieve this standard, a quality management system should be implemented using a risk based approach a ..read more

Liliana Omar, Regulatory and Quality Project Manager Managing change requires vigilance. Between May 2020 and May 2025 products certified under the Medical Device Directives and under the Regulations will coexist in the market. This means that both types of certification will have equal status under the law. With this in mind, manufacturers are executing their transition plans based on the transitional provisions of the regulations, but if something is sure in our environment, it’s that change is continual. To ensure a successful transition, continual surveillance of the regulatory landscape a ..read more

Alison Golla, Clinical Project Manager Adding PROs to study adds value for all stakeholders. The Value of PROs In this long overdue era when data from the patient perspective are being used to assess the safety, effectiveness, and value of medical products, the acceptance and use of Patient-Reported Outcomes (PROs) in clinical trials continues to increase. The impetus is largely due to an overall shift from a system based solely on patient risk to a benefit-risk strategy informed, in part, by patient input. The growing trend towards patient engagement throughout all stages of product developme ..read more

Alison Golla, Clinical Project Manager Have you considered the implications of the FDA’s final rule on human subject protection? The FDA’s final rule on Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices recently became effective. The final rule applies to all clinical investigations that enroll the first subject on or after February 21, 2019, and support investigational device exemptions (IDE), premarket notifications (510(k)), requests for De Novo classification, premarket approvals (PMA), product development protocols (PDP), or humanitarian device ..read more