Biotech & Clinical Research
Run every study from site activation to close-out with inspection-ready evidence.
Clinical operations applications and AI agents for study startup, site and participant management, monitoring, deviations, queries and the trial master file.
Built for biotechnology companies, CROs and research networks and clinical development teams.
Works alongside your EDC, IRT and validated eTMF. Round Infinity runs startup, sites, participants, monitoring and deviations around them. Clinical data stays in your EDC.
How Biotech & Clinical Research runs on Round Infinity
Each step shows what the AI agents do, where your team works, the workflow that keeps it controlled and what you track. People approve what matters, and every action is recorded.
Plan the study, sites, timeline and budget
Plan each study with clear milestones for every country and site. AI watches enrollment and site activity against the plan and warns you early about the places that are likely to fall behind.
Get sites activated and ready to enroll faster
Sites are chosen on evidence and activated faster. AI compares candidate sites on past enrollment and performance, and checks the documents each site sends for completeness before your team approves activation.
Keep participant visits and monitoring on schedule
Participants get reminders and preparation instructions in their own language, and answers to logistics questions. Coordinators can see which visits are coming up, which are overdue and where monitoring is needed.
Close queries and protocol deviations on time
Monitoring notes are read for likely protocol deviations, which are graded by severity. Open data queries are summarized by site and chased, and your team makes the call on each deviation.
Close out the study with an inspection-ready TMF
Incoming documents are filed to the TMF automatically, with quality issues flagged as they arrive. When the study ends, the file is already complete and ready for inspection.
Connects to EDC (Medidata Rave, Veeva EDC), IRT/RTSM, Safety databases and eConsent and document management.
See everything in the pack
Business applications
- Study & Milestone TrackerStudies, countries, sites, enrollment and milestones (CTMS).
- Study StartupFeasibility surveys, site scoring and activation checklists.
- Site PortalDocuments, training, safety letters and payments shared with sites.
- Participant EngagementVisit schedules, reminders, travel and stipends.
- Monitoring Visit ReportsVisit plans, findings, follow-up letters and actions.
- Trial Master File IndexExpected documents, completeness and QC status (eTMF).
AI agents
- Clinical Study Operations AI AgentMonitors milestones, enrollment and site activity across the study, predicts which countries and sites will slip, and drafts the weekly status summary for the study manager.
- Site Activation AI AgentReads essential documents submitted by sites, checks them against the country checklist for completeness, dates and signatures, and requests corrections directly from the site.
- Participant Engagement AI AgentSends visit reminders and preparation instructions in the participant's language, answers logistics questions, and reschedules visits within protocol windows.
- Protocol Deviation AI AgentReads monitoring notes and site reports, identifies likely protocol deviations, classifies them by severity, and drafts the deviation record for review.
- Site Query Resolution AI AgentSummarizes open data queries by site, drafts clear follow-up messages to coordinators, and escalates queries that are ageing toward database lock.
- TMF Quality AI AgentClassifies incoming documents to the TMF reference model, extracts metadata, checks quality issues such as missing signatures, and reports completeness gaps before inspection.
- Clinical Feasibility AI AgentScores candidate sites against enrollment history, patient density and past performance, and matches eligible patient pools to open protocols before the first site is selected.
Workflows
- Site feasibility and selectionSurvey, score and select sites.
- Essential-document collectionRequest, review and approve site documents.
- Site contract and budget approvalAgreements and fee schedules signed off.
- Monitoring visit to follow-upPlan, report, letter and action closure.
- Deviation to CAPAAssess impact and drive corrective action.
Reports and dashboards
- Site activation cycle timeBy country and site.
- Enrollment versus planScreened, randomized and drop-outs.
- Open queries and ageingBy site and data manager.
- TMF completeness and timelinessInspection readiness at a glance.
Add use cases for the rest of your operation
The pack covers Biotech & Clinical Research work. Service, scheduling, field service and finance come from use cases, each a separate line on your quote. Teams in this industry often add:
Included with every subscription
The pack and your use cases run on one platform, with one data model, one set of users and one audit trail.
See Biotech & Clinical Research running on your process
Price the pack with your use cases in two minutes, or let us show one priority workflow running with your systems.