Early Clinical Development Support

Biostatistics

Clinical Operations

Medical Writing

Quality Assurance

Safety/Pharmacovigilance

The Situation

An emerging cellular therapeutics company was entering phase 1 clinical testing for their lead hematology candidate based on their antibody-coupled T-cell receptor (ACTR) technology. In order to move their vision for a singular therapeutic platform approach to treat many different cancers through the development process, they needed a plan, processes and hands-on support.

The Solution

BioBridges provided the key functional expertise necessary in biostatistics, clinical operations, medical writing, pharmacovigilance, and quality assurance.

The BioBridges team provided the following:

  • Contributed to and supported the writing and QC of early phase documents related to their IND submission; protocols, briefing documents, investigator’s brochures (IB), development safety update reports (DSURs)
  • Provided strategic biostatistics support and assisted in developing statistical analysis plan (SAP), determining endpoints, and patient populations
  • Provided an Interim Head of Quality upon departure of Full-Time Head of Quality
  • Liaised with FDA for queries
  • Developed and implemented a company-wide program for budget reporting and invoice review and approval
  • Assessed existing pharmacovigilance (PV) processes and supported the creation and/or enhancement of PV procedures, PV compliance structure, PV system capabilities, and PV resourcing model
  • Developed clinical operations SOPs
  • Assisted in completing a competitive landscape analysis, KOL selection, and clinical site evaluation

The Results

Our client was able to achieve an IND submission within corporate timelines and has since used the same structure for 2 additional, successful IND submissions.