Tap into extensive expertise and a wide range of experiences from a journey of more than twenty-five years in clinical information delivery that remains active in ensuring the bringing of new medicines to the market on time and the enhancement of the potential of existing marketed medicines.
Consultancy Services on Offer
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Design, development, deployment, implementation and support of new computing platforms and other tools used for clinical information delivery.
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Data standardisation using CDISC data standards like SDTM and ADaM that are documented using Define-XML and Data Reviewer’s Guides.
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Delivery of clinical information across all phases of clinical development from Phase I to Phase IV together with regulatory submissions that result in successful new medicine registrations.
Recent Successes
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Successful delivery of RECIST data checking tool for use by study programmers, which included checking of investigator assessments against derived counterparts for target lesion and overall visit responses.
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Empowered development of migration strategy for SAS macro libraries from entimICE to LSAF by providing critical expertise on macro selection for migration versus archival, and guiding team members unfamiliar with historical macro usage.
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Ported and implemented SAS environment setup macro suite to LSAF, determining optimal system macro placement for universal access while adapting to platform differences.
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Reconciled conflicting requirements to develop and test a standardised log checking macro across multiple therapeutic areas. Implemented testing via Xray plugin on JIRA, enabling successful release for widespread usage.
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Updated global SAS macros during entimICE migration to in-house systems, creating and refining Microfocus ALM test scripts to validate macro performance across scenarios.
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Developed automated low-code toolkit for producing FDA OSI BIMO regulatory submission data listings from ADaM datasets. Aligned standardised outputs with stakeholders and refined through pilot testing.
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Eliminated manual work in creating regulatory and business presentations by developing a validated SAS macro suite that integrated tabular and graphical outputs while maintaining the context of presented data.
A Solid Track Record
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Successful delivery of dozens of study analyses across a range of therapeutic areas that includes oncology, CNS, CV and urology.
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Supported numerous successful regulatory submissions using extensive programming and CDISC expertise.
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Training of multiple regulatory submission teams on the use of SDTM and ADaM.
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Development of the following components for a statistical computing environment:
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Program building component of its CDISC study data mapping tool.
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Output consolidation tool that combined textual and graphical study analysis output into the same bookmarked PDF file in order of section and output number, along with a table of contents.
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Continually expanding expertise of a range of technologies that includes SAS, R, Python, Julia and XML with knowledge of other technologies constantly being added.