CASE STUDIES

PHASTAR has a leading reputation for providing quality statistics, programming, data management and data science support.

Read from a selection of case studies below to find out more.

PHASTAR was contracted to assist a global pharmaceutical company with their integrated summary of safety and efficacy for a regulatory submission. The work started with assisting the sponsor in defining an integration strategy for approximately 20 phase I studies, six phase II studies and their corresponding extension as well as three phase III studies and their long-term follow-up study. It involved defining a set of relevant analyses sets and reporting periods for both safety and efficacy analyses, ahead of writing up the analysis plans for the phase II pooled analyses, and phase II & III pooled analyses.

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PHASTAR was contracted to assist a pharmaceutical company with the conversion of 16 Legacy studies to SDTM (2 SDTM “Like” phase II studies, 14 Legacy Phase I studies) and with the pooling and reporting activities of their Integrated Summary of Safety (ISS) for a regulatory submission. PHASTAR were supplied with legacy datasets of the 16 Phase I/II studies, Raw CRF, protocol and CSRs, alongside ISS SAP and Shells.

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PHASTAR began a relationship with a top ten pharmaceutical company carrying out statistical consultancy and were subsequently asked to bid to be a partner in a traditional outsourcing model (i.e. the reporting of clinical trials is done independently by PHASTAR using PHASTAR systems and processes). An RFI/RFP process was undertaken, and we responded, giving details of how we would deliver the results of the clinical trials and related deliverables. We were then selected to be one of two strategic partners after agreeing processes, pricing and governance structure. A two-layer governance structure was established, with a quarterly executive review.

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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.

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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.

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PHASTAR began a relationship with a top ten pharmaceutical company carrying out statistical consultancy and were subsequently asked to bid to be a partner in a traditional outsourcing model (i.e. the reporting of clinical trials is done independently by PHASTAR using PHASTAR systems and processes). An RFI/RFP process was undertaken, and we responded, giving details of how we would deliver the results of the clinical trials and related deliverables. We were then selected to be one of two strategic partners after agreeing processes, pricing and governance structure. A two-layer governance structure was established, with a quarterly executive review.

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Blinded outputs were programmed internally by a sponsor and we had an independent statistician who attended the meetings and gave statistical advice. The sponsor created blinded outputs outside of their standard reporting environment so that we could easily recreate outputs using a standalone SAS environment. We were supplied the DMC charter for review prior to finalization.

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PHASTAR was engaged to report a phase I/II oncology study in advanced NSCLC with an initial phase I escalation followed by a phase II expansion. The objectives covered defining the maximum tolerated dose and having a preliminary assessment of efficacy using RECIST 1.1 as well as PK/PD endpoints. For this study, PHASTAR was using the sponsor’s system – a UNIX based platform with a web-based front end to manage the SAS programming. The sponsor had dataset standards in place and we were required to have all non-standard variables approved by the sponsor’s standards committee. There were over 100 new variables added to the sponsor’s standards in this study. All dataset programming was validated using Pinnacle 21 tools.

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PHASTAR provided a team of statisticians and programmers to deliver the analysis and reporting of a program of four trials in a genetic rare disease, and the corresponding integrated summary of efficacy and safety, to support a regulatory submission to the FDA. There were four studies comprising twelve, one, two, and three patients. The one and two patient studies were pilot studies that included historical data from hospital notes that had been transcribed into a new clinical trials database (after obtaining informed consent from the patients). The three patient study was a compassionate use study that had been initiated due to patient requests.

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