Startup
Activation Blockers Surface Late
IRB submissions, contracts and credentials move in parallel across sites. Without one view, the blocker is usually found after the escalation meeting.
Clinical Trial Management System
Plan, Track and Manage Study Operations End to End With Clinera CTMS.
Operational visibility across multi-center trials, from site activation and milestones to monitoring visits, investigator payments and cross-site analytics.
- IRB / EC Submission Tracking
- Planned vs Actual Milestones
- Electronic MVR Sign-Off
- Milestone-Triggered Payments
Operations Dashboard Active Study View
The Operational Gap
Why Study Status Is Always Out of Date.
Multi-center trial operations usually live across a startup tracker, monitoring folder, payments workbook and inbox. Clinera CTMS turns those fragments into one operational record.
Monitoring
Visit Reports Sit in Drafts
Monitoring reports are written, circulated and closed weeks after the visit. Findings that should trigger action stay buried in unsigned documents.
Inspection
Evidence Has to Be Assembled
Activation dates, signed visit reports and payment triggers are reconstructed from trackers, folders and mailboxes when teams need them most.
One Operational Record
Centralize Startup, Milestones, Monitoring and Site Financials.
Clinera CTMS keeps operational status readable from the system rather than compiled for every meeting. It connects with the Clinera platform so site status and enrollment stay aligned.
01
Startup in One Pipeline
IRB and EC submissions, contracts, activation checklists and investigator credentials tracked per site.
02
Planned Against Actual
Study milestones carry target and actual dates, so slippage is visible while it can still be recovered.
03
Visits That Close
Pre-study, initiation, interim and close-out visits are scheduled, documented and signed electronically.
04
Payments With Evidence
Milestone-triggered payment rules keep site financials tied to the operational record.
Capabilities
Core CTMS Features and Capabilities.
Five modules cover the operational lifecycle: site onboarding, milestone tracking, monitoring visits, site financials and cross-site analytics.
Feature 01
Site Onboarding and Regulatory Submission Pipeline
Keep every site's route to activation visible while it is still being walked.
- IRB and Ethics Committee tracking - Submission dates, meeting dates, queries and approvals recorded per site.
- Contract execution - CTA status tracked beside the regulatory route, so blockers are clear.
- Activation checklists - Outstanding items shown against activation criteria instead of private notes.
- Investigator credentials - CVs, licences, training records and delegation logs stored by site and individual.
Startup Pipeline
Site Activation
SiteStageStatus
Apollo HospitalIRB ApprovedReady
KokilabenContract ReviewBlocked
FortisCredentialsOpen
Max Super SpecialityActivatedLive
One delayed contract is visible beside regulatory status, credentials and activation criteria.
Feature 02
Milestone and Timeline Management
Track planned against actual on the milestones that decide whether a study is on schedule.
- Study-level milestones - First patient in, 50% enrollment, last patient last visit and database lock.
- Variance visibility - Date gaps are shown as they open, when a recovery plan is still useful.
- Site-level rollup - Study timelines reflect real site performance rather than a separate forecast.
Milestone Timeline
Planned vs Actual
FPIOn Track
50% Enrollment7d Risk
LPLVPlanned
DB LockPlanned
24
Active Sites
83%
Target Achieved
36
Open Queries
Feature 03
Monitoring Visit Management
Schedule the visit, write the report and close it out in the same place.
- Full visit coverage - Pre-study, initiation, interim monitoring and close-out visits with the right report structure.
- Electronic sign-off - PI and clinical project manager signatures captured inside the system.
- Findings that carry forward - Actions stay open against the site until they are closed.
Monitoring Visit Report
Site 04 - Interim Visit
Open Findings
Consent version mismatch
Drug accountability follow-up
Source note correction
Sign-Off Route
CRA ReportComplete
PI SignatureSigned
CPM ReviewPending
Feature 04
Site Financials and Investigator Payments
Connect what a site did to what it gets paid, with the evidence attached.
- Site budget models - Per-visit and per-procedure budgets managed per site.
- Milestone-triggered rules - Payments release on defined study events instead of manual reminders.
- Invoice tracking - Site invoices tracked against the budget and the triggering milestone.
- Financial audit logs - Every payment records what triggered it, who approved it and when.
Site Financials
Milestone-Triggered Payment
Screening VisitTriggeredApproved
RandomizationTriggeredReview
Interim MonitoringNot TriggeredWaiting
Audit Trail
Trigger, invoice, approver and timestamp stay attached to the payment record.
Feature 05
Executive Dashboards and Cross-Site Analytics
Read study health from the operational record rather than from a status deck.
- Enrollment heatmaps - Under-performing centers become visible before the shortfall is structural.
- Monitoring velocity - CRA visit throughput tracked against the operating plan.
- Query backlog and SLA - Open queries measured against target resolution times.
- Study health scores - A comparable portfolio read across enrollment, monitoring and data metrics.
Executive Dashboard
Study Health
Enrollment
On Plan
Monitoring
At Risk
Queries
Improving
Workflow
From Site Selection to Database Lock.
The study moves through four operational stages, and the record from each one stays available for the next.
01
Select and Activate
Selected sites enter the startup pipeline, where submissions, contracts, checklists and credentials are tracked to activation.
02
Plan the Timeline
Study milestones are set with planned dates, from first patient in through database lock.
03
Monitor and Sign Off
Visits are scheduled, documented and electronically signed by the PI and project manager.
04
Pay and Report
Milestone rules release site payments while dashboards read live from the same data.
Use Cases
Where Teams Put Clinera CTMS to Work.
Recurring operational jobs across running studies and portfolios.
Faster Activation
Multi-Center Study Startup
Run activation across sites with blockers visible per site, so escalation goes where it is needed.
Real Oversight
Sponsor Oversight of a CRO
Sponsors see monitoring completion, enrollment and query backlog directly from the study record.
Inspection Ready
Inspection Preparation
Activation dates, signed visit reports and payment approvals are already in one controlled record.
Comparable Status
Portfolio Review
Study health scores and milestone variance give operations leadership a comparable read on every active study.
Role Benefits
Role-Based Workflow and Benefits.
Four roles work the same operational record from different ends: startup, monitoring, site delivery and oversight.
RoleKey Capabilities in Clinera CTMSKey Benefit
Clinical Ops Lead
Run the startup pipeline, set milestones and track planned against actual across sites.
Slippage visible while there is still time to act on it.
CRA / Monitor
Schedule monitoring visits, document reports, raise findings and close follow-up actions.
Visit reports close in days instead of sitting unsigned.
Principal Investigator
Review and sign visit reports, track site milestones and see payment status.
Clear view of what the site owes and what it is owed.
Sponsor / CRO Lead
Read cross-site enrollment, monitoring velocity, query backlog and study health scores.
Oversight from live data rather than a compiled report.
Why Clinera CTMS
What Makes Clinera CTMS Different.
01
Operations Next to the Data
CTMS and EDC share the Clinera platform, so operational dashboards read from the same study foundation instead of a weekly export.
02
Financials Tied to Evidence
A payment is linked to the milestone that triggered it and the approval that released it, creating a record finance and audit teams can follow.
03
Sized for Real Studies
Built for sponsors, CROs and research institutions that need control without the weight of an enterprise CTMS rollout.
Specifications
Platform and Compliance.
Clinera CTMS is deployed as part of the Clinera platform and inherits its security, audit and access-control model.
- Modules
- Site onboarding, regulatory submissions, milestone tracking, monitoring visits, site financials and executive dashboards.
- Electronic Signature
- PI and clinical project manager sign-off on monitoring visit reports with signer identity, role and timestamp.
- Audit Logging
- Operational and financial audit trails for status changes, milestone updates, visit report sign-off and payment approvals.
- Platform Integration
- Shares the study record with Clinera EDC and connects with Clinera Survey and Clinera Communications.
- Access Control
- Role-based permissions across sponsor, CRO, monitor, investigator and site staff, applied per study and site.
- Visit Types Supported
- Pre-study, site initiation, interim monitoring and close-out visits with report templates and sign-off routes.
FAQ
Frequently Asked Questions.
If We Have a CTMS, Do We Still Need an eTMF?+
Yes. The CTMS is the operational system of record for site status, milestone dates, visit completion and payment triggers. The eTMF holds the documented evidence filed for inspection.
How Do You Avoid Entering the Same Information Into CTMS and EDC Twice?+
Clinera assigns one system of record per data domain. Subject and visit data belongs to the EDC and is read by the CTMS. Site status, milestones and financials belong to the CTMS.
Does Electronic Sign-Off on a Monitoring Visit Report Support 21 CFR Part 11?+
Sign-off captures signer identity, role, intent and timestamp against the specific report version. Compliance also depends on your validation and procedures, so validation documentation is provided for quality review.
How Are Investigator Payments Triggered?+
Payments are released by rules tied to defined milestones, such as a completed visit or enrollment threshold. Each release is checked against prior payments on that budget line.
Can We Bring a Study Across Mid-Flight?+
Yes. Active studies can be onboarded with historical site status, milestone dates and payment position. Source-data gaps are identified during migration mapping.
Next Step
Schedule a Clinera CTMS Demo.
Bring your current startup tracker and one site budget. We will show how the same information looks once activation, milestones and payments read from a single record.