Protocols, digitized.
Definitions, centralized.
Systems,
connected.
On your cloud.
Revectra turns every clinical protocol — legacy or new — into a structured CDISC USDM 4.0 study definition, centralizes it, activates it across every downstream system through a single API, and generates study documents with AI. One source of truth. Zero re-keying. Deployed on your cloud. Purpose-built for clinical teams adopting Digital Data Flow.
Every clinical trial begins with a protocol - the single document that defines objectives, endpoints, arms, visits, eligibility criteria, and the full schedule of activities. It contains everything every downstream system needs. And yet, that information remains locked inside a PDF.
So every team interprets it again. EDC rebuilds the schedule. CTMS re-keys the visits. IWRS reconfigures the arms. Medical writing starts the monitoring plan from a blank page. The same protocol data is re-read, re-typed, and re-verified across three-to-five systems per trial - each introducing its own errors, its own delays, and its own version of the truth.
What this actually costs you.
Weeks of manual interpretation before a single downstream system can be configured.
Inconsistent study designs across teams that trigger rework, protocol amendments, and regulatory queries.
Study data scattered across PDFs, spreadsheets, and siloed tools - with no version-controlled source of truth.
Monitoring plans, data management plans, and PI/PD plans rewritten from scratch for every trial.
Entire legacy libraries - every completed and ongoing trial - locked in PDFs that can't feed a modern, digital trial operation.
The infrastructure layer that turns a static document into the connective tissue of your entire trial. Revectra solves the hardest, most overlooked problem in Digital Data Flow - what happens after the protocol is finalized.
It digitizes every protocol you have - legacy or new - into a structured, version-controlled study blueprint. One definition, centrally stored, available to every team and every system that needs it. Medical writing, data management, clinical operations, vendor partners - all reading from the same source of truth, with full audit trails, and without ever moving your data outside your environment.
Your protocols are your most sensitive pre-submission IP. Revectra is engineered to run inside your environment - your trial data never leaves your boundary, your compliance posture never changes, and your IT team never has to file another SaaS exception.
Upload one protocol or a library of them. Clinical AI agents extract every study design element and map them to CDISC USDM 4.0 - every extraction confidence-scored and surfaced for human review. What used to take weeks takes a working session.
Every digitized study definition lives in a centralized, version-controlled repository - CDISC-validated, amendment-tracked, and ready for every downstream system. EDC, CTMS, IWRS, eCOA, central labs - they self-serve when they need it.
Generate PI/PD plans, Central Monitoring Plans, and Data Management Plans directly from your digitized protocol - not from generic templates. Every generated element traces back to the source definition. Your team reviews and refines instead of writing from scratch. Medical writing time compresses. Consistency across trials goes up.
You bring the protocol. Revectra does the heavy lifting - while your team stays in control of every decision that matters.
One protocol, or your entire legacy library in bulk. No pre-processing, no manual tagging.
Clinical AI agents read the protocol the way an experienced data manager would - identifying objectives, endpoints, arms, visits, activities, and eligibility - and structure them into a CDISC-compliant study definition.
Every extraction comes with a confidence score. Reviewers approve, edit, or reject in a single clean interface. You stay in control of what gets published.
The validated definition becomes the single source of truth - instantly available to every downstream team and system, and ready to generate study documents on demand.
Every element traces back to the source protocol. Every action is logged. The entire pipeline is auditable end-to-end - built for 21 CFR Part 11 and ICH E6(R3) readiness from day one.
Upload a protocol PDF or Word document - single or in bulk. Purpose-built clinical AI extracts every study design element (objectives, endpoints, arms, epochs, visits, activities, eligibility), maps it to CDISC USDM 4.0, and surfaces every extraction for human review with confidence scoring and transparent quality metrics.
Every digitized study definition lives in a centralized, version-controlled repository - CDISC-validated, amendment-tracked, and built for 21 CFR Part 11 and ICH E6(R3) readiness. Complexity scoring, schedule-of-activities mapping, and protocol summaries, all in one place.
Expose validated study definitions to every downstream system in your stack via a standards-based API - EDC, CTMS, IWRS, eCOA, central labs, and your own internal platforms. Bulk ingestion and flexible export ensure Revectra fits the way your trial operations already work.
Generate PI/PD plans, Central Monitoring Plans, and Data Management Plans directly from your structured study definitions - grounded in your digitized protocol data, not generic templates. Every element is traceable to its source.
Standardize biomedical terminology across your trials, compare protocol versions to identify amendment changes, and validate extracted definitions against public trial registries for consistency between your internal and external protocol information.
Deploys inside your AWS, Azure, or GCP environment. Protocol IP and study data never leave your infrastructure - no multi-tenant SaaS, no compliance trade-offs.
Revectra is engineered around the standards your regulators, auditors, and IT security teams expect.
A guided walkthrough of the platform - from protocol upload to structured, API-accessible study definition, through AI-generated documents and full traceability. Built around the questions your team is actually asking.