Late phase is an exciting stage of your clinical development as it transitions from testing to commercialization. A highly qualified team of executives and specialists leads our Real World Evidence (RWE) and Late Phase Research efforts with years of clinical, observational, and economic research experience. Marketing authorization is in progress, and we’re ready to help you connect the dots and sustain momentum. Stakeholders including regulators, payers, physicians, and patients all need to be satisfied that your drug or device is safe, effective, and offers greater value or benefit than current standard of care. BBMCT’s Regulatory & Access consulting organization – an elite team of 500+ consultants help clients chart the best, most-efficient, course through global regulatory, market access and commercial hurdles.
We’ve integrated regulatory and market access expertise to provide a source of disruptive innovation for clients looking for competitive advantage across every step of their development programs. Our Regulatory & Access consulting organization includes ~100 former regulators and HTA assessors to share innovative thinking, and practical, actionable insights. Because they wrote the guidance yesterday, our consultants know exactly how to interpret it today to give you a strategic advantage.
BBMCT’s Real-World Evidence (RWE) experts help companies explore the impact of a therapy and/or disease in a real-world setting and generate real-world data that can support your proposition to regulators, payers, physicians and patients. We understand the need for interconnected, patient-specific that’s longitudinal in order to track outcomes over time, and we are helping many companies solve this challenge including with the use of hybrid prospective/retrospective RWE studies.
As the market access landscape continues to evolve, the timing of RWE and Late Phase Research is becoming increasingly important. Drawing upon our experience and expertise, BBMCT can help you determine the best timing for initiating analyses earlier in the product development cycle and planning for later phase and post-marketing analyses. Whether it be earlier or later in the development cycle, BBMCT can generate relevant evidence through the design and execution of prospective and retrospective observational studies including registries, safety studies, and expanded access programs. In addition, BBMCT also has the capability to conduct standalone or piggyback economic analyses, such as cost-minimization and cost-effectiveness analyses, budget impact modeling, and evaluation of health-related quality of life (QOL) and other patient-reported outcomes (PROs).
- Expertise, resources and infrastructure to conduct earlier phase trials while designing and implementing plans for RWE and late phase research in support of your product
- Develop post-approval strategies that are well-integrated with early-stage clinical development plans
- Medical, regulatory, clinical, and RWE and late phase experts are deeply embedded in your studies to provide strategic and operational leadership
- Breadth of resources to conduct global research yet an agile culture that enables rapid adaptability as study requirements shift
- Targeted site selection reflecting real world drug and medical device use
- Dedicated submissions team to accelerate startup
- Global and localized regulatory leadership from early phase through late phase
- Late phase randomized clinical trials (IIIb and IV)
- Observational epidemiologic studies
- Post-authorization safety studies
- Expanded access programs
- Health economics and outcomes research
- Competitive marketing claims studies