Thousands of TMF documents across multiple sponsors. ICH-GCP compliance tracked in spreadsheets. Regulatory submission packages assembled manually for every country filing. Site monitoring reports taking days to process. DxLogic builds AI workflows that automate the documentation overhead — so your clinical operations teams focus on trial execution, not paperwork.
Book Your AI Assessment →Purpose-built automation for full-service CROs, functional service providers, and site management organizations.
AI monitors TMF completeness across every study and every sponsor in real-time. Tracks essential documents against ICH-GCP reference models, flags missing artifacts the day they’re due, and maintains audit-ready status continuously — across hundreds of concurrent trials.
AI processes monitoring visit reports from every CRA across every site. Extracts findings, flags protocol deviations, tracks action item resolution, and generates trend analysis across your entire site portfolio. Your clinical operations team manages by exception, not by report review.
AI assembles regulatory submission packages — CTAs, INDs, safety updates, and country-specific filings. Cross-references against FDA, EMA, and ICH requirements per jurisdiction. Your regulatory affairs team reviews complete packages instead of assembling from scratch across multi-country trials.
AI monitors adverse event data across trials and sponsors. Detects signals, validates reporting timelines against ICH E2B requirements, and generates safety narratives. Flags potential expedited reporting obligations before deadlines are breached. Your PV team acts on signals, not spreadsheet reviews.
AI consolidates data from CTMS, EDC, eTMF, and safety databases into sponsor-ready dashboards and reports. Enrollment status, site performance, protocol deviations, and financial metrics — delivered on schedule without manual compilation. Every sponsor gets their data in their format.
AI tracks essential document collection across sites — IRB/IEC approvals, regulatory authority notifications, investigator CVs, lab certifications, insurance certificates. Flags missing documents per site, per country, per sponsor requirement. Your startup team activates sites faster.
How enterprise CROs eliminated documentation bottlenecks and saw measurable ROI.
If any of these describe your organization, we built this for you.
Dozens of sponsors, hundreds of sites, multi-jurisdiction regulatory filings. AI unifies the documentation flowing between clinical operations, regulatory affairs, pharmacovigilance, and quality — giving leadership real-time visibility across the entire trial portfolio.
Embedded in sponsor teams with different CTMS, eTMF, and safety systems. AI normalizes data across sponsor platforms so your teams deliver consistent quality and reporting — regardless of the sponsor’s technology stack or process requirements.
Managing investigator sites across multiple CROs and sponsors. AI tracks essential documents, regulatory submissions, and enrollment metrics per site — giving your operations team a unified view instead of logging into 15 different sponsor portals.
Book a free 30-minute AI Assessment. We’ll map your highest-volume documentation workflows, identify where manual processes are costing you millions in overhead, and show you the 3 workflows with the highest ROI.
First workflow live in 60 days. Cancel the retainer with 30 days notice. No lock-in.