Program Management, Cross-Functional Project Teams, and Acquisition Support

Biostatistics

Clinical Operations

Data Management

Medical Writing

Quality Assurance

The Situation

A virtual company submitted their first IND and needed an effective and nimble project team to oversee their clinical program, develop clinical documents for regulatory submissions, and support overall business development.

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:

  • Developed Clinical Affairs SOPs
  • Developed randomization schemas and authored SAP
  • Professionals (Clinical Operations, Biostatistics, Quality Assurance) served as Management Team to develop actionable strategies to meet clinical and business objectives.
  • Managed Ph1 and Ph2 studies, including training, monitoring, and oversight
  • Managed vendors and clinical monitoring activity, performing services as the primary point of contact for clinical operations.
  • Facilitated DSMB meetings
  • Participated in Type C and EOP2 meetings
  • Authored protocol and IB updates, clinical sections of all regulatory submissions, and CSR
  • Contributed to the development of press releases and business development presentations
  • Presented program for investment bankers and potential acquirers

The Results

Our client met all internal timelines with their clinical studies and business objectives, and sold one of their assets to a private, specialty pharmaceutical company.