FUNCTIONAL SERVICE PROVISION

CASE STUDY

PHASTAR has a number of sponsor relationships where we provide teams of statisticians and statistical programmers to complement the internal teams within medium and large pharma companies.

For example, we provide a large integrated production team of statisticians and statistical programmers to a large global pharmaceutical company. The PHASTAR staff primarily work from our offices supporting this company’s development projects across the full range of phase I to IV clinical trials. This PHASTAR integrated production team includes both management and technical oversight. A structured Governance process is used to provide oversight of the integration of the PHASTAR and sponsor teams.

Work is conducted using PHASTAR laptops with a secure network connection to this sponsor’s 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 (senior 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. A dedicated 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 we continue to meet the sponsor’s expectations.

Production of ISS/SE Package

PHASTAR was contracted to assist a global pharmaceutical company with their integrated summary of safe...

Read More

Interim Analysis and DMC

Blinded outputs were programmed internally by a client and we had an independent statistician...

Read More

Phase I/II Oncology Study

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

Read More

Preferred Partnership

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

Read More