Regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), continue to hold sponsors responsible for CRO performance quality and safety compliance. As a result, unbiased oversight is quickly becoming a key facet of clinical trials. To address this, Beaufort introduced the industry’s first independent quality oversight program and developed new and advanced approaches to CRO quality oversight, good clinical practice (GCP) auditing, good manufacturing practice (GMP) management, corrective and preventive actions (CAPA) management and more.
Beaufort delivers expertise spanning all regulatory development pathways (including IND, NDA, orphan drug and EMEA submissions) to build, implement and enhance quality strategies throughout study and trial life cycles. We have a strong background in Phase I-IV clinical trial co-monitoring and monitoring, and that experience will ensure your clinical trials run smoothly, without incurring warning letters, clinical holds or other cost- and time-consuming setbacks.
From performing investigator assessments, site visits and quality system audits, to aligning research conduct with the protocol, Beaufort’s proven quality solutions will help you align your clinical research execution with your expectations.
Whether you need to find one seasoned professional for a specific assignment or you need to staff an entire clinical team, trust Beaufort. We maintain an extensive global network (reaching 25+ countries) of 1,500+ experienced clinical research associates (CRAs), medical monitors, regulatory affairs specialists, CRA managers, in-house CRAs and more. Not only can we help you build a qualified team of any scale, we can place specialists where you need them to get the localized expertise you need.
Beaufort will find the experts you need to conduct research, support rigorous quality standards and guide region-specific regulatory strategies. With several staffing models — from functional outsourcing and staff augmentation to contract or permanent placement solutions — trust Beaufort to solve your staffing challenges.