Data management oversight

CASE STUDY

PHASTAR was engaged to conduct 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 performed an evaluation of the data cleaning, query management and quality control processes. The provision of data from 3rd party suppliers was assessed and reconciliation issues identified and communicated to all parties. We performed review of dictionary coded terms and coordinated the Sponsor and CRO teams and Medical Representative to resolve inconsistencies.

PHASTAR reviewed the deliverables for database lock of the first study which included adjudication of protocol deviations, targeted spot checks on key data and deep-dive interrogations into data to address anomalies. Subsequently PHASTAR conducted a gap analysis of electronic edit checks and implemented remedial processes to ensure key data critical to endpoints and safety were adequate to deliver the quality and integrity for reliable analysis. We hosted a lessons learned assessment to ensure process improvements were adopted during the conduct of the second study.

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

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