Trial Management that addresses risks The experienced trial management address risks such as: Scarce enrollment Multiple protocol amendments Poor patient retention Poor data quality Prolonged trial completion timeline Poor safety monitor
Tagged: CRO Managment
Trial failures can arise from factors such as failing to maintain suitable protocols, being unable to follow FDA guidance, complex procedures for participating patients, slow recruitment, lack of efficacy, safety issues, and/or insufficient funding to complete a trial. BBCR experts provide an understanding of the reasons a trial failed and offer insights to create and execute successful clinical trial management protocols and CRO management.
May 16th, 2023 | CRO ManagmentBBCR’s team of experts help clients match treatments to rare genetic conditions and unsolved diseases, then work cohesively with a product developer on the best plan to market.
May 4th, 2022 | CRO Managment
Did you know that about a third of orphan approvals by the FDA since the program began have been mostly for repurposed mass-market drugs? Drug repurposing acts to lower the need for early stage clinical trials and can help identify new uses for existing drugs. We invite you to learn more about how BBCR can […]
BBCR has experience in biologics for rare diseases and can assist with the development of a targeted strategy to meet your study needs.
March 24th, 2021 | CRO Managment
Biologic treatments show promise in providing clinical solutions to a variety of diseases including rare cancers and precision medicine. Services include: Indications analysis and prioritization Strategic drug assessment Clinical study design and protocol Biomarker strategy Early Clinical Development FDA meeting and submission Pre-ND integrated development plan CRO and project management Study remediation and rescue […]
Our experienced CRO Management and Drug development team identify study remediation strategies and provide a resource for any Study Rescue
December 10th, 2019 | CRO Managment
Every clinical study has its unique challenges that initially may not have been factored for. Experienced management can help sponsors to address prolonged trial timeline and high quality data. Rare Diseases and Precision Medicine Require Unique Approaches In Clinical Trial Design. There could be any number of factors that could necessitate a study being rescued. […]