PHASTAR 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.

Integrated Summary of Safety

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)

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Production of ISS/ISE Package

PHASTAR was contracted to assist a global pharmaceutical company with their integrated summary of safety and efficacy for a regulat...

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Functional Service Provision

PHASTAR has a number of sponsor relationships where we provide teams of statisticians and statistical programmers (S&P) to augment the...

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Event Prediction to Guide Clinical Study Design

Following the completion of an early phase clinical trial, the sponsor was planning a larger phase IIb study with the same compound but wanted to...

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Interim Analysis and DMC

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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Preferred Partnership

PHASTAR started a relationship with a top ten pharmaceutical company carrying out statistical consultancy and were subsequently were asked...

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PHASE III Asthma Study

PHASTAR was engaged to rescue another CRO’s reporting of a large phase III study in mild asthmatics to evaluate the efficacy and safety of the experimental compound. With a primary objective to prove superiority in asthma control, analyses consisted of a complex primary endpoint and a broad range of secondary endpoints which are typically observed in respiratory.

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Sample size for a diagnostic study

Recently PHASTAR aided on design input and sample size calculations for a study using a new diagnostic test to detect sepsis in blood samples...

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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 initial phase I escalation followed by a phase II...

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Rare Disease Reporting and Regulatory Support

PHASTAR provided a team of statisticians and programmers to deliver the analysis...

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Data Management Oversight

PHASTAR is currently conducting oversight of data management activities on behalf of one of our established clients, a large pharmaceutical company...

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