Our Team at B2 Research has over 40 years of experience in pharmaceutical and medical device product development. We have taken numerous products from Concept to Approval both here in the US and in Europe. Whether you need help filling a resource gap or just don't have the capacity to execute on your plans, B2 Research can provide a wide range of skills to assist you.
Strategy & Organization
Strategic planning along with organizational capabilities are critical to the success of any business. Our experience in working with both small start-up organizations along with running large departments (>25 people) at large multi-national corporations gives us a strong back ground in how to align the business strategies and organization capabilities across your company. We can assist your team in aligning these to insure a clear strategy for project execution moving forward.
In order to have regulatory success today, your company needs to tell their story in a clear, simple and concise manner. Most engineers and researchers struggle with the simplification that is needed to explain complicated topics. Having written and reviewed hundreds of protocols (clinical, design verification/validation, pre-clinical, etc.) and reports, our team can help assist yours in conveying your message and information in a way that can be digested by external reviewers such as the FDA and Notified Bodies. Whether it is consolidating the various ideas from your clinicians into your clinical protocol or explaining difficulties you had during verification/validation, our team can assist you with these efforts.
Clinical trial success can only be accomplished with a well organized Clinical Operations plan. From aligning the protocol with the data management plan, to site monitoring and reporting, we have >15yrs experience in running both pharmaceutical and medical device studies. This includes international studies and FDA PMA studies in excess of 2,000 patients. We can help set your clinical team up for success by providing the key planning tools and deliverables to make your trials the best in the industry
The key to most business plans is "time to market". The one item that continually delays that timeline is all of the Product Development activities. We have experience developing large and small volume parenteral injectables, implantable medical devices as well as combination products (drug/device). We understand the critical studies that need to be conducted to reduce the risk to the overall program timeline insuring the fastest possible "time to market".
Good Project Management can insure that all the pieces of the complex puzzle in Product Development are put in the right place. We have over 40 yrs of combined Project Management experience where we have managed multiple programs in excess of $100MM in annual R&D spending. Your team needs to focus on their deliverables and B2 Research can keep the Project on track with our ability to see the big picture and insure that deliverables and contingency plans are established and remain on time.
Quality System Support
Whether it is an ISO 13485 audit, an FDA Pre-approval inspection or BIMO audit, we have prepared for and participated in >20 on-site audits with various regulatory agencies and internal audit teams. Our experience in both Product Development and Clinical Operations has always been focused on putting Quality at the forefront of all systems and decision making processes. We can help identify the gaps in your systems or highlight the key areas to make your systems more robust to the scrutiny in todays complicated regulatory environment.