Situation:
Rapidly growing biopharma entering Global Phase 3 development without an appropriate clinical quality system and little internal expertise in clinical QA.
Solutions:
- Gap Analysis conducted by Halloran found that the Quality System was overly complicated and hard to manage, causing significant non-compliance by the team.
- Worked with the team to develop and implement a scalable quality infrastructure for growth plans.
- Managed vendor and clinical site audits as needed for the duration of the global Phase 3 program.
- When requested, Halloran provided regular Good Clinical Practice training to meet the qualification standards as defined by the company.
Value:
The company conserved internal resources and successfully avoided hiring additional clinical quality full time employees. They used Halloran for all quality activities throughout their pivotal program and subsequent initiative.