Case History: Drug firm sees substantial ROI in productivity software for statistical analysis planning

The Problem

A major pharmaceutical company was faced with high costs for hiring outside contractors to write Statistical Analysis Plans (SAPs) for drug protocols.  Contractors are used because statisticians, overwhelmed with the analytical work required for drug studies, have little time for the difficult and intensive effort needed to write an SAP.

The company needed to find a way to improve the consistency of the plan organization, the writing quality, and the thinking behind the process itself.  It also wanted to take some of this work back in-house to save cost and time.  But the solution had to produce an immediate return, with a limited amount of effort from internal resources.  It also had to be a natural fit into the daily workflow and business processes.

The Solution

Over an eight-week period, Acappella^® Software consultants worked with three of the company's top statisticians, who each invested 3 to 4 hours per week.  Together the team developed a web-based application that allowed statisticians to generate a significant majority of the narrative for an SAP document in a matter of hours.

After only three months, the application was deployed to one of the company's statistical operations units.  The statisticians themselves are maintaining and evolving the application, without having to depend upon the IT department for making changes or updates.  The solution is being assessed for enterprise-wide deployment, including translations into other languages.

The Results

All performance objectives were either achieved or exceeded.  Turnaround time on SAP documents is much faster.  Quality is consistent.  Statisticians are getting the technology support they need.  Supervisors are spending more time mentoring and less time reading and rewriting SAP documents.

After spending two years on other attempts at a solution, the Acappella^® application was built in three only months.  There was very little disruption to normal workflow and the demand on internal resources was minimal.

The company reports a 63% savings in cost-to-decision - the real dollars expended to execute the SAP process and create the required report.  The company is estimating an ROI of 363% over the first year, 720% compounded over the first two years, and an anticipated three-year cost of ownership IRR of 449%.