Every Study in View.Every Trial File Inspection-Ready.
Agents classify and check every trial document, draft monitoring reports, find site issues as they emerge and keep each study’s trial master file ready for inspection. Your teams see the whole portfolio in one place and approve every result.
A sample clinical operations view. All studies, sites and numbers are made up.
One Governed Architecture for Every Study
Agents read across the trial systems you already run, share one controlled knowledge base and work under one governance layer. Every result goes to the person who owns the decision.
Your trial systems
Your people decide
For the Teams Who Keep Trials Inspection-Ready
Whether you run one study or a global portfolio, in-house or through partners, agents take the filing, checking and cross-referencing and your teams keep the judgment.
Heads of Clinical Operations
The health of every study in one view: TMF, monitoring, queries and site issues, with the evidence behind every score.
Study and Program Managers
Issues that repeat across sites surface early, with the action to take at each one.
TMF Leads and Specialists
Documents classified and checked as they arrive, so your team handles only what needs judgment.
CRAs and Monitors
Visit reports drafted the day of the visit from your notes and the data, ready for you to edit and sign.
Clinical Quality Assurance
Inspection readiness checked continuously, with findings traced to the document and the procedure.
Sponsor Oversight
The same view across every partner and vendor, so oversight does not depend on monthly reports.
Every Trial Document Filed in Minutes
Documents arrive from sites, vendors and study teams. Agents classify each one to your TMF model, extract its metadata, check its quality and file it, with anything uncertain held for a TMF specialist.
Your TMF Model
Documents are classified to the zones and artifacts of the TMF model you use.
Checked on Filing
Signatures, dates, versions and site details are checked before a document is filed.
Specialists Where It Matters
Low-confidence and failed documents go to a TMF specialist with the reason.
Monitoring Visit Report · Site 112
Findings and Follow-Up
Source data verification was completed for 8 of 8 enrolled subjects.12 Two follow-up items from the January visit remain open: a missing ECG and a late SAE report.3
Subject 1110 signed consent version 3 after version 4 was approved, and was reconsented on March 12.4 The site will close both open items before the next visit on April 20.13
Visit Reports Drafted From the Visit
Monitors spend hours writing up each visit. Agents draft the report from the visit notes, the EDC data and the open issues list, with every statement linked to its source, and the monitor edits and signs it.
Drafted the Same Day
Reports are ready for review the day of the visit, not a week later.
Every Statement Sourced
Each sentence links to the visit note, the EDC record or the issue it came from.
Signed by the Monitor
The monitor reviews, edits and signs every report.
Queries, deviations, emailsLive
Subject signed consent v3 after v4 approval
Consent versionConsent date before amendment approval
Consent versionWhich consent version should we use now?
Consent versionReconsent not documented, site 121
Consent versionConsent version field blank
Consent version- All 9 issues involve consent version 3
- All 4 sites are in the second wave
- No issues at first-wave sites
- Recommended actions
- Send the version 4 notice to second-wave sites
- Schedule reconsent for 6 subjects
- Add a version check to site activation
Issues Across Sites, Found as They Emerge
Queries, deviations, monitoring findings and site emails are read together across the study. Related issues are grouped as they happen, with the likely cause and the action that fixes it at every site.
Every Source Together
Queries, deviations, findings and site communications, read in one view.
Patterns Across Sites
An issue that looks local at one site is grouped when it repeats at others.
Fixed Everywhere
Each issue comes with the action to take at every affected site.
Inspection-Ready Every Day, Not Just Before the Inspection
Agents check each study’s TMF against its plan as documents arrive, so readiness is a state you keep, not a project you run.
- Continuously1
Completeness and Timeliness
Every study is checked against its expected document list, with missing and late documents raised the day they are due.
- Before the inspection2
Readiness Package
Gaps, late filings and their explanations assembled for each study, country and site.
- During the inspection3
Requests Answered
Inspector requests answered from the TMF in minutes, with the filed document on screen.
- After the inspection4
Findings to CAPAs
Findings turned into draft responses and CAPAs, tracked until each one is closed.
AI You Can Defend to an Inspector
Every agent is qualified before use and monitored after, under the same quality system as the rest of your computerized systems.
Qualified Before Use
Each agent version is tested on cases your experts graded and must meet your acceptance criteria before release.
Calibrated to Your Experts
Agent classifications and findings are compared with your TMF and quality reviewers, and agreement is reported for every version.
Part 11 Audit Trail
Every input, output, change and signature is recorded, retained and exported for your validation package.
Aligned to the Standards You Answer To
Agents work from your procedures, your TMF plan and the regulations your studies follow.
GCP and Trial Conduct
- ICH E6(R3) Good Clinical Practice
- 21 CFR Parts 50, 56 and 312
- EU Clinical Trials Regulation 536/2014
Trial Master File
- TMF Reference Model
- EMA guideline on the TMF
- Your TMF plan and index
Records and Systems
- 21 CFR Part 11
- EU GMP Annex 11
- ALCOA+ data integrity
ThinkTrends checks your documents against the procedures and plans you provide. Inspection outcomes remain with the regulator.
Built for Clinical Operations
ThinkTrends runs in your environment, keeps a qualified person on every decision, and keeps your data out of model training.
Your Team Approves Every Filing
Agents classify, check and draft. TMF specialists, monitors and study managers decide, and every decision is recorded.
Your Data Never Trains a Model
Cases, labels, trial data and documents are used to do the work and nothing else.
Runs in Your Environment
Deploy in your cloud or data center, with patient and product data kept inside your boundary.
Validation Evidence Included
Each agent version is tested against your acceptance criteria, and the results are ready for your validation file.
21 CFR Part 11 Aligned
An audit trail no one can edit, electronic signatures with their meaning, and access by role.
Configured, Not Coded
Rules, routes, checks and thresholds are settings your administrators can read and change.
Related Modules
The platform modules these solutions are built on.
Frequently Asked Questions
Common questions about ThinkTrends Clinical Operations.
What does ThinkTrends offer for clinical operations?
+
ThinkTrends offers agentic AI for clinical operations teams at sponsors and research organizations. Agents classify and quality-check every trial document to your TMF model, draft monitoring reports from visit notes, group site issues as they emerge and keep each study inspection-ready, with the whole portfolio in one view. Your teams approve every result.
How is ThinkTrends different from eTMF or CTMS automation?
+
eTMF and CTMS systems store and track trial documents and activities. ThinkTrends reads the content across them: it classifies and checks each document before filing, drafts monitoring reports, groups related issues across sites and checks completeness against your TMF plan, then files results into the systems you already use.
How does ThinkTrends keep a trial inspection-ready?
+
Each study is checked against its expected document list as documents arrive, so missing and late documents are raised the day they are due. Before an inspection, agents assemble gaps and explanations by study, country and site, and during it, requests are answered from the TMF with the filed document shown.
Can sponsors use ThinkTrends to oversee partners and vendors?
+
Yes. ThinkTrends gives sponsors the same view of TMF health, monitoring and site issues across every partner and vendor, built from the documents and data themselves rather than monthly status reports.
Which TMF model does ThinkTrends use?
+
The one you use. Documents are classified to your zones and artifacts, following the TMF Reference Model or your own.
Does ThinkTrends replace our eTMF?
+
No. It classifies, checks and files documents into the eTMF you already use.
Who signs ThinkTrends monitoring reports?
+
The monitor. Agents draft the report from the visit notes and data, and the monitor reviews, edits and signs it.
Is our data used to train AI models?
+
No. ThinkTrends uses trial documents only to do the work, inside your own environment. Your data is never used to train, tune or evaluate a model.