Cross-Functional Submission Preparedness

Biostatistics

Clinical Operations

Data Management

Quality Assurance

Safety/Pharmacovigilance

The Situation

An emerging oncology and rare disease company with little internal infrastructure was experiencing rapid growth after demonstrating potential efficacy in phase 1 of their first oncology indication and was moving towards a fast-track submission. As the company worked to expand their internal infrastructure, they needed functional expertise across disciplines to ensure development success.

The Solution

BioBridges provided the functional expertise necessary for our client to develop and successfully move their first oncology program through clinical trials and into submission. Support was provided in the following areas: biostatistics, clinical operations, data management, pharmacovigilance, and quality assurance.

The BioBridges team provided the following:

  • Oversaw CRO clinical operations, data management, pharmacovigilance, quality assurance, and SAS programming activities
  • Conducted vendor audits and prepared for inspection readiness
  • Assisted with SOP development, case processing, and vendor management
  • Engaged our medical writing function to create SOPs, CSRs, and protocols
  • Collaborated on SAS programming needs
  • Assessed PV technology
  • Provided mentoring and training to junior CRAs

The Results

Our client’s first oncology application was submitted for expedited approval. They have continued to build their program pipeline and are now running multiple programs with the support of BioBridges professionals.