sustainable quality

The role of the Statistical Programmer is increasingly important in the overall clinical trial process.

statistical programming clinical trialsStatistical programming has become more of a niche role in which the programmer is tasked with turning data into comprehensive analysis and knowledge for the rest of the study team. Programmers are expected to not only have programming knowledge, but a basic – if not advanced knowledge – of statistics. In today’s clinical trial space, they are also expected to learn and become experts in industry standards such as CDISC mapping standards.

As clinical pipelines grow and the demand for programmers increases, how can Sponsors build a programming team delivering sustainable quality? More importantly, how can Sponsors stay within budget without sacrificing quality along the way?

The Functional Service Provision Model is an ideal solution for both large and small trial Sponsors looking to have control over their statistical programming outputs without carrying the burden of continous progress planning and training.

The FSP model facilitates a scalable and expert team of resources for a particular function, like statistical programming, to address specific challenges like maintaining quality, improving efficiency and continuous training. In this case, these tasks fall under the responsibility of the CRO.

Properly Managing the Team

Under the FSP model, the CRO delivers a dedicated FSP Manager, expert in biometrics data services, in order to:

  • Assign senior and principal level statistical programmers specialized in the study’s therapeutic area
  • Ensure sustainable quality through the assessment of programming KPIs
  • Periodically assess skills of the programmer and adjust training plans accordingly
  • Integrate and train the programmers on Sponsor’s SOPs and processes
  • Accurately forecast workload to be able to scale up quickly as needed

Considering the Human Resources Element

Sponsors can rely on a good FSP model to eliminate recruitment and human resources hassles and costs such as:

  • Finding a dedicated team of resources, since the CRO and its recruitment partners are responsible for providing the best team of resources based on a profile that matches the Sponsor’s needs
  • Delivery of an induction plan and target-setting to ensure employee progression
  • Implementing a mentoring system to guide new employees
  • Management of sick leave and holidays to ensure 100% coverage of forecasted workload
  • Evaluating the cultural fit in terms of geography and company culture

Multi-level Communication

FSP projects can contain large teams of statistical and SAS programmers or the relocation of teams to a Sponsor’s site. The CRO, under the responsibility of the FSP Manager, manages a detailed communication plan including:

  • Smooth integration of company culture, pipeline and development plans as well as team structure and responsibilities
  • Communication between FSP Manager and the programming team and the FSP Manager with the Sponsor’s PM
  • Project governance strategies to support successful oversight of the relationship
  • Delivery of metrics and KPIs as well as project status, milestones and other issues

Functional Service Provision programmingAll elements of a successful FSP plan based on sustainable quality also tie into pricing structures. The FSP model guarantees flexible, but stable, pricing models that do not fluctuate over time. Guaranteed coverage is built into the pricing models as well as human resource management and continuous training of resources.

When it comes to outsourcing a niche and expert role such as statistical programming, the Sponsor should ensure the CRO has a history of quality resources that meet the profile of the company requirements. The Sponsor maintains control over their statistical programming processes while  the CRO guarantees sustainable quality deliverables.