In this blog we share a case study of how we established and ramped up a functional service outsourcing partnership for biostatistics, programming and data management.
Background
Effective use of the right outsourcing solution can enable companies to respond to market needs and change course where necessary, while ensuring a pool of highly qualified personnel are available to work on their clinical trial projects. For a larger biopharma company the Functional Service Provider (FSP) model can be an attractive option, providing access to 100% dedicated resources to work across multiple programs while managing costs.
Challenge
Our client, a top 20 biopharmaceutical company, expected a significant increase in the number of clinical trials they would conduct. They therefore needed to exponentially increase data management, statistical analysis, and programming resources to support the clinical data analysis. They decided to transition from a tactical resourcing model to a dedicated FSP partnership that could better support their assertive ramp up plans.
Solution
Significant planning was conducted from both sides to ensure that strong communication, trust and shared objectives were in place from the outset.
To facilitate strong connections and communication between the Cytel FSP team members and their sponsor counterparts the team was established within the customer's region.
An assertive ramp-up of over 50 statisticians, and statistical programmers was targeted over 12 months to meet the client’s clinical trial plans.
A detailed operational plan for on-boarding was created and outlined that FSP personnel would initially work with sponsor leads before transitioning into functional study lead roles.
A governance plan was put in place defining clear communication pathways between the various stakeholders, and Key Performance Indicators to ensure that the partnership was kept on track.
Outcome
Cytel achieved ramp-up of the statistical programming requirement ahead of schedule and met an extended ramp-up plan inside 12 months.
The sponsor has benefited from streamlined communications, and a reduced administrative requirement.
The partnership has been able to develop pools of niche expertise based on the client’s pipeline of activity and area of focus.
Success Factors
Cytel’s dedicated recruitment resourcing team was able to use their combined years of headhunting experience to attract high quality talent to the partnership in a highly competitive marketplace.
A tailored recognition program was put in place to reward the partnership team members and promote team spirit.
Positive team spirit and collaboration creates the good will and flexibility necessary to meet the shifting timelines, priorities, and general demands of modern drug development.
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