@@ -74,6 +74,9 @@ to replace SAS® with R, use both, or explore other alternatives like
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Python. Instead of adopting an either-or scenario, leveraging the
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strengths of each programming language for specific Data Science
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problems is recommended, recognizing that one size does not fit all.
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+ Despite the challenges early adopters of R have faced in regulatory compliance,
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+ there have been notable successes that highlight the benefits and potential of
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+ using R in regulated industries.
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Early adopters of R have faced challenges, with regulatory compliance
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for R packages being a common issue.
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@@ -100,7 +103,7 @@ The pharmaceutical industry has witnessed the emergence of various R
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packages tailored for Clinical Trial reporting. Examples include
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` {rtables} ` for creating tables for reporting clinical trials,
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` {admiral} ` for CDISC ADaM, ` {pkglite} ` to support eSubmission, and many
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- others. These packages cater to different aspects of clinical trial data
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+ others. Pharmaverse packages cater to different aspects of clinical trial data
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analysis, showcasing the versatility of R in this domain.
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This article talks more about use of R in clinical trials and how this
@@ -150,24 +153,14 @@ approach.
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Ensuring data quality, scientific integrity, and regulatory compliance
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through risk assessment frameworks, validation, and documentation are
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- imperative in this dynamic landscape. The pharmaceutical industry's
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- journey toward embracing R reflects the broader trend of industries
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- recognizing the value and potential of open-source tools in addressing
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- complex challenges.
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+ imperative in this dynamic landscape. Pharmaverse is also actively steering
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+ the pharmaceutical industry's path by pioneering connections and advocating
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+ for R, thus exemplifying the broader trend of industries acknowledging the
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+ value and potential of open-source tools in tackling complex challenges.
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![ Leveraging the Right Tools] ( RightTool.png ) {fig-align="center"}
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- ## Author
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-
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- Venkatesan Balu is the Associate Director, Global Data Sciences, Navitas
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- Life Sciences with 15+ years of experience in the Biostatistics domain,
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- and in Phase I to Phase IV Clinical Trials across various therapeutic
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- areas, BABE and PK studies. He has invaluable expertise in providing
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- inputs to study design, sample size, SAP, outlier evaluation, interim
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- analysis, complex statistical evaluation & model selection, and
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- regulatory requirement. He is a technical leader in drug development
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- strategy, adaptive design, portfolio optimization, and decision-making
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- in clinical trials.
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+
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<!-- ------------- appendices go here ----------------->
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