FUNCTIONAL SERVICE PROVISION

CASE STUDY

PHASTAR has a number of sponsor relationships where we provide teams of statisticians, statistical programmers and/or data scientists to augment internal teams within medium and large pharma companies. These range in size from 3 to 60 individuals.

For example, we provide a large integrated production team of statisticians and statistical programmers to a global large pharma. The PHASTAR staff work both from our offices and the sponsor’s site supporting this company’s development projects across the full range of phase I to IV clinical trials, including submission support such as the creation of integrated efficacy and safety databases. This PHASTAR production team includes both management and technical oversight, ensuring the smooth running of the clinical projects and maintaining the highest quality standards. A structured governance process is used to provide oversight of the integration of the PHASTAR and sponsor teams, and share projections of forthcoming work and PHASTAR resources available.

Whilst we are comfortable using a variety of system configurations, in this example the programming work is conducted using PHASTAR laptops with a secure network connection to this sponsor’s web-based production systems. Sponsor SOP and system training is managed by PHASTAR so that each member of the PHASTAR production team is fully credentialed and trained on the sponsor’s systems and processes.

Technical oversight is provided by technical operations managers (management level statisticians and statistical programmers) that handle technical and resource review and oversight. These individuals provide key guidance to the integrated production teams in support of this sponsor’s needs. These individuals participate in the governance process with the sponsor. The PHASTAR account manager is responsible for business related issues with this sponsor.

When new requests for statisticians and statistical programmers arise, we submit proposals of suitably qualified and experienced personnel. We have a monthly governance committee to oversee the overall partnership, where we share available PHASTAR resources and present forthcoming requirements. PHASTAR’s account manager liaises with the sponsor’s managers to ensure all contracts are in place in a timely manner and that their expectations are being met. This relationship has been in place for a number of years and the size of the relationship is growing due to positive feedback on the quality of our work.

Production of ISS/SE Package

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Interim Analysis and DMC

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Phase I/II Oncology Study

PHASTAR were engaged to report a phase I/II oncology study in advanced NSCLC with an...

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Preferred Partnership

PHASTAR started a relationship with a top ten pharmaceutical company carrying out statistical consult...

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