Building 66, located at the FDA White Oak Campus in Silver Spring, Maryland, is a pivotal facility for the U.S. Food and Drug Administration (FDA). It houses explicitly the Center for Devices and Radiological Health (CDRH). This building is part of a larger campus that embodies the FDA’s commitment to operational excellence and scientific advancement in public health.
Read MoreThe Clinical Data Interchange Standards Consortium (CDISC) is a global nonprofit organization that is pivotal in standardizing clinical research data. Founded in 1997, CDISC aims to develop and promote data standards that enhance the efficiency of clinical trial data collection, analysis, and submission. This comprehensive post will delve into CDISC’s structure, standards, and impact on clinical research, regulatory submissions, and the broader healthcare landscape.
Read MoreIn today’s competitive clinical trial landscape, CROs are indispensable. They help sponsors manage the complexities of trial protocols, patient recruitment, and stringent safety standards. Several CROs have emerged as leaders, with the global clinical trials market growing rapidly. Below, we explore the 10 largest CROs, highlighting their strengths, global reach, and contributions to clinical research.
Read MoreDon't miss out on a fantastic chance to participate in the hybrid 2023 International Conference on Pharmacoepidemiology. Esteemed specialists in the field will delve into the realm of Advancing Pharmacoepidemiology and Real-World Evidence for the Global Community.
Read MoreInclusion criteria are important in clinical trials because they define the specific characteristics and eligibility requirements that potential participants must meet to be included in the study. This helps to ensure the safety of participants, the validity of study results, and the ethical conduct of the trial.
Read MoreIn a clinical trial, a composite endpoint combines two or more individual endpoints (also known as component endpoints) into a single, combined outcome measure. The purpose of creating a composite endpoint is to provide a more comprehensive assessment of the treatment effect and to capture multiple clinically relevant events that may occur during the study. Composite endpoints can also play essential roles in providing statistical power to the study.
Read MoreA Data Safety Monitoring Board (DSMB), also known as a Data Monitoring Committee (DMC) or Independent Data Monitoring Committee (IDMC), is an independent group of experts responsible for monitoring the safety and efficacy of a clinical trial while it is ongoing. The primary role of the DSMB is to ensure the well-being of study participants and to maintain the scientific integrity of the trial.
Read MoreIn the rapidly evolving field of medical devices, software plays a critical role in enhancing their functionality and performance. As the demand for innovative healthcare solutions continues to rise, regulatory bodies such as the U.S. Food and Drug Administration (FDA) have established guidelines to ensure the safety and effectiveness of medical device software. In this blog post, we will explore the content of premarket submissions for device software functions, shedding light on the essential aspects Companies must consider when seeking regulatory clearance.
Read MoreClinical trials are relevant to demonstrate the safety and performance of Medical Devices, and the design of a clinical study can be [statistical] art on its own. Not only is it essential that the trial will be viable, but there is also often the uncertainty of it being accepted as sufficient by the regulatory authorities.
Read MoreA proposed FDA regulation has been published, requesting public comments, to modify the existing requirements of the Quality System (QS) regulation (21 CFR Part 820) for medical device quality management to incorporate the international standard AND address the needs of medical devices manufacturers. The proposed regulation, if approved, would help to harmonize the U.S. requirements for QMS with the requirements of the International Organization for Standardization (ISO).
Read MoreIn this article, Biomedical Statistical Consulting's (BSC) Biostatistician Brendan Keenan and co-authors confirmed a previously unreported gene affecting sleep duration in mouse models.
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