Clinical Development Guidance and Support

Clinical Development

Clinical Operations

Data Management

Quality Assurance

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.