The AI Orchestration Layer for Clinical Trials. From Protocol to Closeout.

Innovo Copilot is clinical trial AI software for sponsors and CROs. Role-trained AI agents plan studies, author documents, and monitor trial data, connected to your EDC, CTMS, and eTMF.

"The Innovo platform provides the executive-level visibility we need to ensure our global trials remain on schedule and compliant in every region."

Novo Nordisk

60,000+
Global Sites

800+
Global Trials

300,000+
Global Users

Trial Complexity Is Outpacing the Tools Built to Manage It.

Clinical trials today involve increasing regulatory requirements, complex protocols, and growing operational demands across global study sites. Organizations need smarter, more efficient ways to streamline processes, reduce delays, and accelerate study execution.

  • Protocol Complexity

    Design gaps in complex protocols lead to amendments and deviations that ripple through every downstream study document.

  • Study Startup Delays

    Fragmented systems and manual handoffs stall the path to first-patient-in.

  • Site Engagement Issues

    Disconnected communication and heavy document burden leave sites slow to respond and hard to support.

  • Monitoring Inefficiencies

    Without central monitoring across sponsor and CRO systems, risks surface late and oversight stays reactive.

The FDA found it.
Why didn't we?

The trial lifecycle was built as a sequence of handoffs, not a system, and intelligence is lost at every one. The regulatory bar has moved: oversight must be risk-based and technology-enabled.

ICH E6(R3) • GCP • FDA-ADOPTED SEP 2025

Risk-based, quality-by-design oversight

The first GCP overhaul in three decades — explicitly embracing modern technology, data governance, and risk-based monitoring across the trial.

FDA AI GUIDANCE • DRAFT • JAN 2025

AI must be credible & risk-assessed

The FDA’s first framework for AI in drug development sets a risk-based bar for the credibility of any model that informs a regulatory decision.

The Solution

One agent layer across the whole trial

A single layer of AI agents reasoning across every process, every source, and every system so intelligence never gets lost in the handoff.

Closed loop across the trial lifecycleAn outer loop Plan, Author, Monitor and Submit around five lifecycle stages: Design / Feasibility, Protocol, Study Startup / EDC Build, Conduct / RBM, CSR / Submissions.Design /FeasibilityProtocolStudy Startup /EDC BuildConduct /RBMCSR /SubmissionsPLANAUTHORMONITORSUBMITClosed loop

Plan → Author → Monitor

Every phase feeds the next. Intelligence accumulates across the trial lifecycle rather than resetting at each handoff.

  1. Plan

    “We amended three times. What were we designing against?”

    Evidence & feasibility, before you design. Design grounded in evidence from prior trials, real-world data, literature, and your own organizational memory.

    • Synthesizes prior trials, real-world data & literature
    • Validates I/E criteria against patient populations
    • 300M+ records for feasibility validation
    • Delivers a structured, evidence-grounded synopsis
  2. Author

    "We spent a million dollars fixing something that should never have been in the protocol."

    Protocols, plans & documents governed. AI‑backed drafting turns governance from a six‑week bottleneck into convergence.

    • Evidence-backed drafting with AI QC agents
    • Auto-drafts ICF, CRF & DMP from approved protocol
    • Generates RACT, TMP & SMP from the protocol
    • Amendment cascade push changes to every related doc
  3. Monitor

    "When did you know the trial was off track, and why are we only hearing about it now?"

    Risk-based, live, protocol-aware oversight. Oversight that surfaces risk as it emerges tied to its timeline impact, with the right action attached.

    • One live site-risk score across EDC / CTMS / eTMF
    • Breach → CAPA → verified closure, automatically
    • Role-based dashboards grounded in the plan
    • Every insight references the exact TMP / SMP section

One protocol. Every plan. Actionable intelligence. End to end.

Want to learn more about how clinical AI capabilities can supercharge your clinical operations? Contact us today with our “Request a Demo” form or email us at info@innovocommerce.com for more information. Our team is ready to answer your queries and help you make an informed decision.