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Services

Phase 1 to submission

A highly skilled team supporting clinical programs across statistical programming, CDISC transformation, computing environments, and data management — with DoLoup's agentic automation behind every deliverable.

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CDISC services

SDTM and ADaM data transformation, define.xml data definition documentation, controlled terminology, and compliance checks against your selected IG version — submission-ready, every time.

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SAS & R programming

Analysis datasets, tables, listings, and figures in SAS 9.4 or R. Programs are drafted, run, and log-cleaned through DoLoup's agentic loop, then independently QC'd.

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Biostatistics

Statistical analysis planning, review, and support for electronic submissions — grounded in decades of regulatory experience.

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Statistical computing environment

SAS 9.4 server installation on-premise or in the cloud, programming-environment configuration (Pinnacle 21, R and packages, comparison tools), and IQ/OQ/PQ validation documentation ready for regulatory review.

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Data management

CRF design, custom database builds, data entry, discrepancy management, monitoring reports, and delivery in CDISC models.

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Project management

CRO process management, budgets, timelines and deliverables, RFP production and bid review.

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Custom software solutions

Purpose-built clinical software with 21 CFR Part 11 compliance and complete validation documentation.

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Training

CDISC implementation, data definition documentation, SAS validation, and thesaurus coding — delivered for your team, on your data.

Next step

Bring the loop to your study

Every service we deliver is accelerated by DoLoup — our agentic automation platform for clinical SAS programming.

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