Is Reprosia available now?
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Reprosia is currently in private early access. We are working with a small number of pharma and biotech teams to refine the platform before a wider release. Submit a request and we'll assess fit and timeline together.
Do I need to migrate away from my existing R setup?
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No. Reprosia wraps around your existing R environment — your scripts, packages, and data pipelines stay where they are. We add the audit, validation, and submission layer on top, not instead of what you already have.
How does Reprosia handle sensitive clinical trial data?
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Reprosia is operated by ReproStats BV, a Belgian-registered entity. All data processing occurs within EU jurisdiction, GDPR compliant by default. We support on-premise deployment options for teams with strict data residency requirements. Clinical data never leaves your controlled environment unless you explicitly choose to share it.
Is the IQ/OQ/PQ documentation acceptable to FDA and EMA?
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Reprosia generates validation documentation aligned with FDA 21 CFR Part 11, EMA Annex 11, and GAMP 5 computer system validation guidance. The documentation format is designed to satisfy regulatory reviewers. That said, acceptability ultimately depends on your specific regulatory context and submission, and we recommend review by your regulatory affairs team.
Can Reprosia help with SAS to R migration?
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Yes. This is one of our core use cases. Reprosia provides automated equivalence testing between SAS and R outputs, migration audit trails documenting every difference and its justification, and a parallel validation period where both environments run simultaneously. The migration package is designed to produce agency-acceptable evidence of the transition.
How is Reprosia different from just using renv and git?
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renv and git are excellent tools and Reprosia builds on them. The difference is the regulatory layer: IQ/OQ/PQ documentation, 21 CFR Part 11-compliant audit trails, electronic signatures, risk scoring, drift detection across environments, ICH E9(R1) estimand documentation, and eCTD-ready submission packaging. renv locks your packages; Reprosia certifies your environment and produces the evidence that regulators require.
What is the relationship between Reprosia and ReproStats?
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ReproStats (reprostats.org) is the open-source project — four R packages (reproducr, regulog, lineager, estimandr) available on CRAN and GitHub. Reprosia is the enterprise platform built on that foundation, adding the AI audit engine, environment management, submission tooling, and enterprise workflows. Both are operated by ReproStats BV. The open-source packages remain free and will always be maintained independently.