Sponsor Type: Biotech Start-up
Trial Phase: Phase I
Region: Australia
Functions Supported: Regulatory, Site Engagement, Clinical Operations, Project Management, Medical Writing.

The Challenge:

Phase I study data integrity at risk due to an inexperienced Sponsor and poor communication advice. Critical internal audit finding necessitated CRO change.

Our Solution:

• Deployed fractional project director, quality manager, medical writer, CRA and CTA, each within less than a week of identifying the need
• Implemented a QMS with company SOPs
• Contracted an experienced DM & Stats company to hit the ground running – a pragmatic decision, as quicker than setting up the team
• Initially reassured sites that the issues identified were being addressed
• Once eTMF and eCRF transfer had occurred, re-engaged with sites to re-monitor
• Data set was confirmed to be reliable and data base lock occurred
• Medical writer drafted shell CSR to shorten report writing timeline

The Outcome:

ClinFlex Partner team implemented new company process structure and closed out the study with confidence in data integrity.