We understand the need to maximize success while minimizing time and costs. That’s why we strategically positioned our laboratories within close proximity to our clinical research units and developed our Fast Track approach—an efficient and powerful process that can save you six to 12 months on your entire Phase I-IIa development program. We’ve achieved a 95% on-time study start and completion rate through our innovative application of technology, integration of clinical and bioanalytical services, and unique access to patients.
Pressure to contain the rising costs of drug development continues to force biopharmaceutical sponsors to find ways to inject efficiencies into the research process. As a result, early phase study design and its effect on predicting late phase research outcomes is critical.
BBMCT early phase teams provide innovations in translational medicine techniques – bench to bedside strategies – supporting success early on. BBMCT offers comprehensive services for the outset, incorporating comprehensive services to ensure success.
Termed Translational or “bench to bedside” medicine, the concept forms the initial basis for evidence-based practice and clinical guidelines. In the case of drug discovery and development, translational research typically refers to the translation of non-human research finding, from the laboratory and from animal studies, into therapies for patients. BBMCT Early Phase uses many facets of translational medicine to facilitate the interaction between basic research and clinical medicine to design and conduct clinical trials including use of biomarker endpoints, bioanalytical methods, adaptive trial design and collaborative scientific teams over multiple disciplines.
This thoughtful design of studies in the Early Phase translates to efficiencies through-out late phase studies, affecting success rates of bringing promising compounds to a successful approval status.
From protocol design to Clinical Study Report (CSR) delivery, we can meet the needs of essentially any early phase study for healthy volunteers, special populations, and early patient trials, including:
- Supporting the manufacturing and Qualified Person (QP) release of any formulation of a drug.
- Providing real-time support for pharmacokinetics (PK) and biomarker analysis.
- Facilitating shortened timelines in early development.
- Converting raw data into decision-point data for our clients.
Our early development solutions include drug development programs, exploratory clinical trials, fast track development, pain studies, patient pharmacology, and target product profiles.