Metabolic studies can be challenging in terms of patient recruitment and study efficiency. Metabolic studies demand rigorous attention to regulatory strategies and safety data. With over a decade of expertise in metabolic diseases ensures the highest standards are applied for the design, conduct and analysis of all studies. Our team has hands-on experience with a wide range of testing procedures and models to detect early signals of safety or efficacy that support better decision making and delivery of efficient drug development programs for you. Specifically, our in-depth knowledge of diabetes and obesity studies ensures best practices are applied, to provide high-quality data that adheres to FDA and EMA guidelines to support regulatory filings.
BBMCT leverages complex predictive models that allow signals of safety and efficacy to be detected in an early phase setting, empowering clients to make better decisions earlier in the drug development process. Anti-diabetic drug development is also burdened with mandated late phase cardiovascular risk assessments. BBMCT provides our customers with an early phase solution for de-risking potential failure of a compound in late phase due to CV risk assessment allowing for the early detection of cardiovascular risk signal, enabling better decision making earlier in the drug development process.
- Diabetes and diabetic complications
- Growth hormone disorders
- Kidney disease
- Metabolic syndrome
- Rare metabolic diseases
Our experience has enabled our endocrinology experts to create strategy plans that expedite timelines and deliver superb data quality, all while maintaining strict adherence to sponsors’ budgets.
We have dedicated staff with years of experience in medical leadership, project management and clinical operations who can execute endocrinology studies with proven effective strategies, wherever in the world, whatever the indication. This leads to rapid study start up timelines, on time deliverables, proactive risk management and quality data delivery, achieving study timelines within projected budgets.
Metabolic studies can be challenging in terms of patient recruitment and study efficiency. Metabolic studies demand rigorous attention to regulatory strategies and safety data. BBMCT successfully navigates the complexities and regulatory scrutiny of endocrine/metabolic development programs.