Data management oversight

CASE STUDY

PHASTAR is currently conducting oversight of data management activities on behalf of one of our established clients, a large pharmaceutical company. After acquisition of a biotechnology company our client requested our support to manage two ongoing pharmacokinetic studies in oncology and rheumatology.

Both studies were conducted using Medidata Rave and were fully outsourced to a large CRO. The studies had suffered due to limited oversight by the previous sponsor and as a result the studies lacked any consistency in their approach and management.

PHASTAR took on oversight of the CRO for both studies to ensure the data management, analysis and reporting deliverables were produced successfully – within the expected timescales and to a high level of quality. PHASTAR reviewed procedural documentation and data management plans, as well as monitoring the data management and quality control processes.

PHASTAR reviewed the deliverables for database lock of the first study and have successfully seen that take place. Subsequently PHASTAR conducted a gap analysis and a lesson learned assessment to improve the conduct of the second study.

The feedback PHASTAR received from the sponsor was that our service had provided “exceptional input and added value”.

Production of ISS/SE Package

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Interim Analysis and DMC

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Phase I/II Oncology Study

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Functional Service Provision

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