Our in-house medical, regulatory and operational experts work collaboratively to support your Phase IIb-III clinical trials. We combine scientific leadership with disciplined execution, global access to patients, and local and global regulatory expertise to accelerate your compound to approval.
- Full-time physicians provide strategic direction for study design and planning, train operations staff, work with primary investigators, provide medical monitoring, and meet with regulatory agencies
- Strategic regulatory leadership guides trial design and execution recommendations
- Long-standing interactions at the medical and operational levels with global key academic opinion leaders and key sites including preferred CRO status at specific sites
- Close collaborations and ongoing programs with high recruiting sites at academic, network, and independent centers
- Dedicated global regulatory submissions teams experienced in key therapeutic and specialty area trial application processes and site start-up
- In-house contract attorneys to expedite contract negotiations and final execution
- Proprietary, integrated clinical study management technology platform facilitates efficient execution of global trials
- Experienced in Data Safety Monitoring Committee management as well as providing ongoing statistical support
- Detailed country and site selection processes to use the best site mix for the program as well as ongoing tracking and site communication to maintain trial timelines
- Focused teams permit BBMCT to address each program’s specific needs and to provide consistent operational excellence
- Comprehensive and rigorous internal training program for CRAs
With comparable challenges always existed in novel drug development programs, our clinical design and operation teams are dedicated to advance and promote the program leveraging the successful experiences based on the completed clinical trials. Empowered by state-of-the-art facilities and experienced professionals, we are confident to be one of the most reliable, committed, flexible clinical partner to develop your clinical program and maximize your success.
- To enhance the success of phase III clinical trial, we will define clinically useful dose range and patient characteristics predictive of drug response.
- To meet specific patient populations intended for marketing, exclusions of screened subjects will be closely examined and carefully justified.
- To facilitate better estimates of drug safety and efficacy, we conduct the subject recruitment strictly, and offer the most experienced statistical experts to ensure the accurate data.
- To facilitate the market success, we can help our client plan the whole clinical trial lifecycle, explore market strategies and even phase IV studies.
- To meet multi-center requirements, we have capabilities to conduct clinical trials in multi-countries, or multi-sites in one country. Our clinical experts are familiar with culture, standards of care, regulatory guidelines of various countries.
- To fulfill different requirements of global agencies, we off a comprehensive suite of full services.
- To avoid any delays or reduce any risks, we plan on quality in every stage.
Phase IIb and phase III are the most crucial stages during the drug clinical development. We offer end-to-end suite of services, and relentlessly focus on your drug approval. Because the goal of regulatory approval is in sight, you need to outsource your clinical trial to an end-to-end partner. Our comprehensive suite of clinical phase IIb-III services will keep your study on track and accelerate the success of market approval.
- Clinical operations and monitoring
- Project management
- Medical monitoring
- Product safety and pharmacovigilance
- Biostatistics and statistical programming
- Clinical data management
- Regulatory operations
- Data standards and CDISC
- Regulatory and medical writing
- Quality assurance
- Clinical trial optimization
- Clinical trial management system
BBMCT is dedicated to working together with our clients to advance the phase IIb-III clinical trials. We combine scientific leadership with efficient execution, large database of subjects, and comprehensive regulatory expertise to accelerate your drug’s approval. Our experience advances your drug through the crucial phase IIb-III trials.