Build
Rapid Study Onboarding
Go from protocol to live with a guided Study Builder. Define phases, sites, arms and visit schedules with zero-code validation.
Clinera Product Suite
Electronic Data Capture Built for the Whole Study.
Clinera EDC unifies data capture, randomization, supply, ePRO, safety tracking and team communication on one platform and one database—keeping studies clean, connected and inspection-ready from enrollment to lock.
No Sales Deck. A Working Study, On Screen, in 30 Minutes.
- 21 CFR Part 11
- ICH-GCP
- GDPR
- HIPAA
- CDISC SDTM Exports
Live Study Overview Inspection Ready
Why Clinera EDC
Four Things Fragmented Clinical Stacks Cannot Do.
Most trials run across an EDC, a separate randomization tool, a safety mailbox and a messaging app. Clinera brings those workflows into one governed environment.
Randomize
Unified RTSM and Supply
Run blocked, minimization and adaptive randomization with real-time kit inventory inside the same platform and database.
Collaborate
Clinical Communication Hub
Discuss participants, queries and safety events in study-scoped channels with a complete, Part 11-ready record.
Comply
Audit-First, ALCOA+ Data
Protect every field-level change with electronic signatures and a chained SHA-256 audit history that remains inspection-ready.
Inside the Platform
Everything a Data Manager Needs. Nothing Bolted On.
Capture, clean, randomize, resupply, track safety and hear from patients—each module purpose-built, all of it one connected system.
Electronic Data Capture
Build CRFs in an Afternoon. Lock Data Without the Chase.
Give data managers a governed path from form design to clean, signed and export-ready study data.
- Intuitive CRF Builder — Drag-and-drop forms with conditional logic, cross-field validation and CDISC SDTM auto-mapping.
- Integrated Query Management — Threaded resolution between sites and monitors shortens data-cleaning cycles.
- Clear Workflow Stages — Every visit moves through data entry, SDV, PI sign-off, freeze and lock.
Data Entry
SDV
PI Sign-Off
Freeze
Lock
CRF Builder
Visit 04 · Vital Signs
Demographics
Vitals
Medical History
Lab Results
Adverse Events
Systolic BP
118
Diastolic BP
76
Heart Rate
72 bpm
Temperature
36.8 °C
All Validation Rules Passed
RTSM and Supply Chain
Randomization and Resupply That Never Fall Out of Sync.
Allocation, inventory and governed unblinding stay connected to the same participants and sites as your EDC data.
- Intelligent Resupply — Automated site restock triggers based on par levels and enrollment velocity.
- Cold-Chain Integrity — Temperature excursion logging and kit-level quarantine workflows are built in.
- Blinded Logistics — Emergency unblinding follows controlled, multi-step approvals without side channels.
RTSM Inventory
Site Supply Overview
248
Available
32
Assigned
04
Quarantine
KitSiteStatus
KT-01842Pune-04Available
KT-01843Pune-04Assigned
KT-01844Delhi-02Quarantine
KT-01845Mumbai-07Available
Clinical Communication Hub
The Conversation About the Data Lives With the Data.
Coordinators, monitors and investigators work in study-scoped channels rather than personal messaging apps.
- Study-Scoped Channels — Conversations stay inside the study boundary and visible only to authorized roles.
- Context Attached — Threads link directly to the participant, query or safety event they concern.
- Fully Audited — Discussion history is retained with the same inspection discipline as the study data.
Study Channel
# site-04-data-review
MC
Monitor
10:42Query Linked to Participant 004-018
SC
Site Coordinator
10:48Source Reviewed. Updating the Visit Form Now.
PI
Principal Investigator
11:03Confirmed and Signed. Ready for SDV.
Safety and ePRO
Safety Events Reach the Right People in Minutes, Not Meetings.
Connect participant reporting, safety review and follow-up without making sites reconcile separate systems.
- SAE Tracker — Capture serious adverse events with automated dispatch over SMS, email and WhatsApp.
- Mobile ePRO — Collect patient-reported outcomes through secure, mobile-optimized forms.
- Multi-Channel Reminders — Prompt patients and sites through the channels they already use.
Patient Experience
Daily Symptom Diary
Today · Visit 04
How Are You Feeling?
No Symptoms
Mild
Moderate
Severe
Submit Response
Study Design Library
From First-in-Human to Post-Market—One Structured Foundation.
Clinera EDC supports clinical study designs across five practical clusters. Every design uses the same audit chain, exports and connected platform.
01
Core Clinical Development
Phase I–IV Clinical Trials
Support safety, dose, exploratory efficacy, confirmatory and post-marketing studies across the clinical development lifecycle.
Randomised Controlled Trials
Run parallel, placebo-controlled, active-comparator, superiority, non-inferiority, equivalence, cluster and platform trial designs.
Open-Label and Blinded Studies
Configure open-label, single-, double-, triple- and assessor-blinded studies with controlled treatment visibility.
Crossover Studies
Manage treatment sequences, periods, washouts, dosing and carryover assessments for within-participant comparisons.
Adaptive Clinical Trials
Support preplanned adaptations such as sample-size changes, dose changes, arm decisions and interim review workflows.
Master Protocol Studies
Coordinate basket, umbrella and platform studies with dynamic arms, cohorts and reusable study components.
02
Specialised Drug Development
Bioequivalence Studies
Capture period and sequence data, dense sampling schedules, dosing, fasting conditions and bioanalytical lab imports.
Biosimilar Studies
Support comparative PK/PD, efficacy, safety, immunogenicity and long-term follow-up programmes.
Pharmacokinetic & Pharmacodynamic Studies
Manage dose cohorts, exact dosing times, timed collection, concentration imports and biomarker assessments.
Dose-Escalation & First-in-Human Studies
Coordinate cohort opening, dose-limiting toxicity windows, safety review, stopping rules and escalation approvals.
Vaccine Studies
Support immunogenicity, booster, lot-consistency, safety follow-up and vaccine-effectiveness study workflows.
Oncology Clinical Trials
Capture regimen cycles, toxicity grading, imaging, biomarkers, progression, survival and quality-of-life endpoints.
03
Medical Devices & Diagnostics
Medical-Device Clinical Investigations
Capture device, procedure, operator, malfunction, reintervention and device-related safety data.
SaMD & Digital Therapeutic Studies
Evaluate clinical validation, algorithm performance, remote monitoring, adherence and digital biomarkers.
Diagnostic Accuracy Studies
Record index and reference-test results, blinded assessment, sample tracking and central adjudication.
IVD Clinical Performance Studies
Support clinical and analytical performance, specimen chain-of-custody, reconciliation and comparator studies.
04
Investigator & Academic Research
Investigator-Initiated Studies
Give hospitals, investigators and academic teams a flexible environment for interventional or observational research.
Academic Clinical Studies
Enable thesis, fellowship, department, society and multicentre academic research with analysis-ready exports.
Pilot & Proof-of-Concept Studies
Test recruitment, intervention acceptability, workflows, site readiness and endpoint suitability before scaling.
Feasibility Studies
Assess whether an intervention, recruitment plan, visit schedule or operational model can work in practice.
Methodology & Validation Studies
Validate questionnaires, clinical outcome assessments, measurements, wearables, imaging or digital biomarkers.
05
Post-Authorisation & Modern Delivery
Post-Authorisation Safety Studies
Support targeted safety surveillance, registries, risk-minimisation studies and long-term follow-up.
Post-Authorisation Efficacy Studies
Generate additional evidence on clinical outcomes, effectiveness, patient subgroups and patient-reported outcomes.
PMS & PMCF Studies
Run post-market surveillance and clinical follow-up for devices, including registries and complaint follow-up.
Decentralised Clinical Trials
Connect remote consent, ePRO, eDiaries, teleconsultations, home visits, wearables and safety follow-up.
Hybrid Clinical Trials
Blend on-site assessment and treatment with remote consent, ePRO, follow-up and central monitoring.
Pragmatic Clinical Trials
Study interventions in routine-care conditions using broader eligibility, real-world sites and meaningful outcomes.
Long-Term Extension Studies
Carry participants and selected data forward to assess long-term safety, effectiveness and continued exposure.
Compassionate Use & Expanded Access
Capture eligibility, treatment exposure, safety events, outcomes and regulatory documentation outside conventional trials.
The Clinera Difference
A Faster System With Fewer Seams.
< 100ms
High Performance
Fast API responses keep large studies responsive for coordinators, monitors and data managers.
One DB
No Synchronization Gaps
EDC, randomization and supply share one cohesive data foundation instead of exchanging fragile copies.
SHA-256
Audit-First Design
A cryptographically chained history makes every material action traceable and tamper-evident.
Technical Specifications
The One-Glance Summary.
- Compliance
- 21 CFR Part 11 · ICH-GCP · GDPR · HIPAA
- Export Formats
- CDISC SDTM CSV · SAS-ready datasets · JSON · PDF case books
- Authentication
- Multi-factor authentication · Granular role-based access control
- Randomization
- Blocked · Minimization · Adaptive · Kit-level RTSM
- Patient Channels
- Mobile ePRO · Secure patient portal · Email, SMS and WhatsApp alerts
- Infrastructure
- High-availability cloud hosting · Controlled document storage
FAQ
Frequently Asked Questions.
How Long Does It Take to Set Up a New Clinical Study in Clinera EDC?+
Thanks to our pre-built Category-B CRF catalog and no-code drag-and-drop builder, standard Phase I-III study builds take between 3 to 10 business days compared to 6-12 weeks on traditional legacy platforms.
Does Clinera EDC Support Mid-Study Protocol Amendments?+
Yes. Clinera EDC features seamless protocol version control. You can add new fields, update visit schedules, or modify validation rules without invalidating existing subject data or breaking historical audit trails.
How Are Data Queries Managed in Clinera EDC?+
Queries are generated automatically when programmatic edit checks fail or manually by CRAs during monitoring. System-wide notification badges and email alerts notify site coordinators, who can respond directly within the form workspace.
Is Clinera EDC Fully 21 CFR Part 11 Compliant?+
Yes. Clinera EDC includes complete Part 11 compliance controls, including cryptographic digital signatures, forced password rotation, session timeouts, role-based permissions, and an unalterable, append-only audit trail.
Next Step
See Capture, Randomization and the Audit Trail in One Live Study.
Bring your protocol. We will walk it through the Study Builder on the call.