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AI-Enabled Clinical Data Solutions

Applying AI and automation across data management, biostatistics, and other functional services — scoped to what your program actually needs.

AI and Automation, Scoped to Your Program

Every sponsor's systems, data volumes, and workflows are different, so there's no single fixed AI product we sell. Instead, we assess where automation can genuinely reduce cycle time or manual effort within your existing data management, biostatistics, coding, or safety processes, then build and validate a solution scoped to that specific need. All AI-assisted output remains subject to the same GCP-aligned review and QC as our standard deliverables.

Where Automation Can Help

  • Data Cleaning & Discrepancy Triage: Automated flagging of likely data issues and outliers to help prioritize manual review, on top of standard edit checks.
  • Coding Acceleration: AI-assisted synonym/verbatim matching for MedDRA and WHO Drug coding, with coder review on every assignment.
  • Programming Support: Assistance with SDTM/ADaM mapping specifications and repetitive TLF shell generation, validated through standard double-programming QC.
  • Document Drafting Support: First-pass drafting assistance for repetitive narrative sections (e.g., standard safety narratives), reviewed and finalized by medical writers.
  • Signal & Literature Screening: Automated first-pass screening of literature and case volume for pharmacovigilance, with PV specialists confirming all findings.

How an Engagement Is Scoped

  • Assessment: We review your current systems, EDC platform, data volumes, and where manual effort is concentrated.
  • Prioritization: We identify the highest-value automation opportunities for your specific program rather than applying a generic template.
  • Build & Validate: Solutions are configured and tested against your data before go-live, with defined QC checkpoints throughout.
  • Integrate: Automation is layered into our existing full-service or FSP delivery model — it supplements our core services rather than replacing the people responsible for them.

Human Oversight, Always

AI accelerates specific, well-defined tasks; it does not replace clinical judgment, coder review, statistical sign-off, or medical writing oversight. Every AI-assisted output passes through the same GCP-aligned QC and human review as the rest of our deliverables, consistent with data integrity principles like ALCOA+.

Curious Where Automation Could Help Your Program?

Tell us about your current workflows and systems, and we'll assess where AI-enabled support could genuinely save time without compromising data integrity.

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