Background:
Bay area based sponsor was developing oncology treatments for unmet needs. The company’s lead Phase II product candidates were being investigated for their potential to provide improved survival rates for multiple indications.
Key Issue:
Manage multiple, complex statistical analysis deliverables for multiple studies, CDISC compliant outputs, and data pooling for NDA submission to the FDA with minimal sponsor oversight.
Project Details:
- Ephicacy leverages a team of 20 programmers and 4 statisticians to support the pivotal Phase 2b and 3 studies
- For the pivotal studies, Ephicacy provided CDISC compliant datasets
- In preparation for submission, Ephicacy CDISC experts prepared a gap analysis reviewing the SDTM compliance
- Ephicacy provided SDTM conversion for the legacy studies for which CDISC compliant datasets were not created
- Ephicacy statisticians prepared the Statistical Analysis Plan for ISE
- Ephicacy provided standardization across studies for the ISS and performed the data pooling for the ISS/ISE from the individual study SDTMs to ADaMs
- Reviewer’s Guides, both for SDTM (cSDRG) and ADaM (ADRG), were prepared for the studies
Success Factors:
- Communication
- Close communication was established both within the project team and with the sponsor Lead Statistician
- Expertise
- Ephicacy CDISC subject matter expert and biostatistician were appointed as project leads to ensure effective coordination and adherence to CDISC guidelines.
- Flexibility
- Ephicacy had a global team available to work around the clock and meet tight delivery timelines.
- Experience
- This was a high visibility project for the sponsor and Ephicacy proactively interacted with sponsor’s senior management
- Efficiency
- A streamlined approach was created across study specific deliverables creating efficiencies, supporting delivery timelines