Case Study: How a Better Biostatistics Fractional Biostatistician Saved a Sponsor Hundreds of Thousands of Dollars

At a glance

This case is a clear example of the power of adding biostatistical leadership, not just programming support. When a Sponsor lacks internal statistical expertise, even the best CRO can struggle. By placing a fractional biostatistician from Better Biostatistics into the study team, we turned around performance, prevented a costly CRO switch, and kept the trial on track.

Why It Worked

A fractional biostatistician bridges the gap between sponsor and CRO by providing leadership, oversight, and scientific direction without the full-time cost of hiring internally. For small and emerging biotechs, this model delivers:

Improved CRO accountability, partnership, and performance

Strategic statistical leadership without the overhead of a full- time hire. Faster decision making and higher quality submissions.

  • The Industry’s Best Biometrics Consultants
  • https://betterbiostatistics.com/
  • info@betterbiostats.com

CHALLENGES

A small biotechnology company was conducting a clinical study and had fully outsourced their biometrics function (biostatistics, programming, and data management) to a global CRO. Without an internal biostatistician to guide strategy or review the CRO’s work, the sponsor found themselves facing delays, increasing costs, and declining confidence in study execution.

SOLUTIONS

Better Biostatistics was able to provide a highly experienced biostatistician as the sponsor’s fractional biostatistician. This person acts as the company’s in-house statistical leader, but on a part-time, flexible basis. The fractional Biostatistician:

CHALLENGES

Better Biostatistics was able to provide a highly experienced biostatistician as the sponsor’s fractional biostatistician. This person acts as the company’s in-house statistical leader, but on a part-time, flexible basis. The fractional Biostatistician:

Provided technical review of all statistical deliverables and ensured they met regulatory expectations.

Aligned the CRO and sponsor teams on design decisions, data expectations, and statistical strategies.

Clarified requirements, answered scientific questions, and unblocked decisionmaking.

RESULTS

1

Re-established trust and clear communication between the sponsor and CRO. The CRO immediately began meeting timelines and delivering high-quality outputs.

2

Cost Savings. The Sponsor did not need to terminate the CRO or pay for a vendor transition, thereby avoiding hundreds of thousands of dollars in additional costs

3

Successful Study Delivery. All future deliverables were submitted on time and on budget. The study got back on track and never became a “rescue study”.