The Situation
An emerging oncology company that relied heavily on outsourcing was moving into phase 3 of their first clinical program. They needed a plan and processes to develop and sustain proper oversight of key functional areas of their phase 3 program to prepare for a successful marketing submission and for future programs in their pipeline.
The Solution
BioBridges provided the functional expertise necessary for our client to develop and successfully execute outsourced and insourced functionality across biostatistics, clinical operations, data management, medical writing, and quality assurance.
The BioBridges team provided the following:
- Assisted in moving the data management functionality in-house and supported subsequent activities during that transition
- Audited, trained, and supported the development of a quality group that was initially primarily experienced in GMP and helped to expand their GCP capabilities
- Created and implemented essential SOPs
- Collaborated with the client teams to develop, write, and execute statistical analysis plans, clinical study reports, and manuscripts
- Acted as liaison and oversaw CRO activity
The Results
Our client received approval to launch their first product to market and ultimately initiated and executed multiple successful clinical programs.
At BioBridges, we have highly skilled consultants with extensive experience in the biotech, pharmaceutical, and medical device industry. With a wide range of expertise, these life science consultants are incredibly well suited to step in and immediately provide valuable contributions to your development programs. Whether you are an emerging start-up or an established company, looking for individuals or functional teams, BioBridges' consultants provide guidance and support to accomplish the objectives across all areas of clinical development. You can accomplish the work with experienced professionals whose passion is to focus on programs that inspire them, move important work forward, and make an impact. Engaging BioBridges gives you the ability to accomplish the work at hand.
Service Areas
Clinical experts can help you bridge the gap between your life's work and a healthier world.