Objective

A small oncology biotech company with an expanding pipeline required a flexible resourcing model of statistical programmers to address their immediate priorities. One crucial need was supporting database lock (DBL) and Clinical Study Report (CSR) activities for a Phase 2 solid tumor study while developing project timelines for key objectives. The Inference team prepared a comprehensive project plan to support these requirements.

Sponsor’s priorities included

  1. Dedicated resources within 3 months
  2. Addressing all statistical activities for regulatory submission (including ISS/ISE)
  3. Establishing systematic processes to have quality RECIST data
  4. Implementing CDISC-compliant standards

Approach

The sponsor selected Inference for expertise in Health Authority submissions and statistical programming. For the Phase 2 study, Inference began with an experienced Lead Programmer and resources from the US-based office, and augmenting with a hybrid US-India team. The team of statistical programmers:

Implemented RECIST Checks

  • Developed an automated programmatic approach to check RECIST data
  • Created concordance analysis between investigator and derived responses
  • Performed concordance analysis between investigator response and BICR data
  • Supported the primary endpoint of Progression-Free Survival by:
    • Forecasting PFS events for Final Analysis timelines
    • Identifying DBL timing and aligning resources accordingly
  • Generated analysis datasets and summary tables for disease progression metrics

Enhanced Data Quality

  • Developed a programmatic approach to check source data quality
  • Implemented automated monthly data quality checks
  • Collaborated with Clinical Operations to identify sites with low compliance in data capture which supported their Clinical Research Associates (CRAs) in source data verification
  • Ensured CDISC compliance for SDTM/ADaM deliverables

Results

1. Efficient Study Execution

    • Met aggressive timelines for database lock (DBL) and on-time delivery of CSR deliverables
    • Established a dedicated programming team for Health Authority submission preparation

2. Enhanced Programming Methodology

  • Implemented automated tools that reduced error risk and helped develop quality CSR deliverables
  • Ensured CDISC compliance for regulatory submissions

3. Scalable Partnership

  • Identified quality process improvements
  • Established regular data concordance reviews
  • Provided flexible resources for pipeline growth

Key Takeaway

Inference delivered high-quality statistical programming solutions tailored to the sponsor’s objectives. The sponsor met their timelines with confidence and remained on track for Health Authority submission. Inference’s flexible resource model helped the sponsor meet their needs efficiently, providing agility and experience to deliver quality CSR deliverables for the Health Authority submission.

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