Next-Generation Clinical Trial Management Software (CTMS) & eSource Platform
Accelerate study execution from protocol design to FDA/GCP inspection. Automate participant recruitment from active hospital EHR charts, capture clinical data with zero double-entry via native eSource, ensure 21 CFR Part 11 eConsent, and prevent protocol deviations through conversational WhatsApp patient retention.
From Protocol Conception to Study Lock & Regulatory Closeout
Click through each phase of study execution to see how ReyanLabs replaces fragmented spreadsheets with an intelligent, connected eClinical operating system.
Protocol Modeling & Visit Schedule Matrix
Configure complex multi-arm protocols, inclusion/exclusion matrices, treatment cohorts, and acceptable visit window tolerances (+/- days) in minutes.
- Visual protocol builder supporting randomized, double-blind, crossover, and adaptive trials
- Configurable visit window tolerances (e.g. Day 14 ± 2 days) with automatic calendar clash resolution
- Centralized IRB/IEC regulatory document binder with digital version control and amendment tracking
Nine Mission-Critical Modules Built into One Unified CTMS
Everything hospital clinical research sites, academic investigators, and contract research organizations (CROs) need to conduct flawless trials.
AI Patient Recruitment & EHR Matching
Accelerate trial enrollment by 40%. Automatically search hospital EMR datasets to find eligible participants matching complex inclusion and exclusion criteria.
- Deep EHR scanning of unstructured doctor notes & labs
- Automated candidate ranking & eligibility scoring
- WhatsApp pre-screening & consent invitation pipelines
- Multi-site referral portal for external community clinics
21 CFR Part 11 Digital eConsent
Paperless, legally compliant informed consent. Supports multilingual patient comprehension quizzes, video walk-throughs, and instant protocol amendment re-consents.
- Cryptographic signatures with IP, timestamp & device audit
- Multilingual video explanations & comprehension tests
- Automated re-consent on protocol amendment approval
- Parental/Legally Authorized Representative (LAR) workflows
Direct EHR-to-EDC eSource Capture
Eliminate double data entry. Clinical encounter data, vital signs, and laboratory feeds flow directly into electronic case report forms (eCRFs) without manual transcription.
- Real-time automated sync with hospital EMR & LIS systems
- Built-in range checks, validation rules & query flags
- Eliminates coordinator manual data entry fatigue
- CDISC ODM and HL7 FHIR R4 compliant export formats
Visit Window & Retention Copilot
Prevent protocol deviations. Intelligent algorithms calculate precise visit tolerance windows (+/- days) and proactively nudge participants via conversational WhatsApp reminders.
- Protocol tolerance window calculator (+/- days)
- Automated WhatsApp appointment confirmations & directions
- Pre-visit fasting instructions & medication hold reminders
- Travel coordination & participant milestone incentives
IMP Drug Accountability & RTSM
End-to-end investigational product tracking. Manage randomization, barcode kit dispensing, temperature tracking for biologics, and empty vial reconciliation.
- Interactive Randomization & Trial Supply Management (RTSM)
- Barcode kit scanning for zero-error blinded dispensing
- Real-time cold-chain temperature telemetry logs
- Pharmacy destruction & return reconciliation records
Pharmacovigilance & Safety Escalation
Real-time safety surveillance. Automatically flag potential adverse events from clinical notes, calculate CTCAE grades, and trigger 24-hour expedited SAE alerts to DSMB.
- CTCAE v5.0 severity classification & MedDRA mapping
- 24-hour automated expedited SAE alerts to DSMB & IRB
- Pre-filled CIOMS I and MedWatch 3500A draft generation
- Independent safety committee portal with blinded data views
ePRO & eCOA Mobile Diaries
High-compliance participant outcome reporting. Collect patient-reported outcomes, symptom severity logs, and quality-of-life surveys over WhatsApp and responsive web.
- Zero app downloads needed — runs on WhatsApp or web browser
- Automated daily/weekly prompts for missing entries
- Visual pain scales, PROMIS, and SF-36 questionnaire templates
- Real-time alert dispatch if severe symptoms are reported
Site Financials & Milestone Invoicing
Automate clinical research finances. Trigger sponsor invoicing upon completed subject visits, manage pass-through laboratory costs, and track investigator grant payouts.
- Per-visit procedure budget tracking & split-fee billing
- Automated sponsor milestone invoice generation
- Pass-through scan & pharmacy cost reconciliation
- Transparent site financial health & budget margin reporting
Inspection-Ready eTMF & Audit Trail
Maintain permanent regulatory inspection readiness. Centralized electronic trial master file structured according to the DIA TMF Reference Model with complete audit histories.
- Immutable chronological audit trail (Who, What, When, Why)
- DIA TMF Reference Model 3.2.0 folder hierarchy
- Role-based permissions for auditors, sponsors, and PIs
- One-click inspection export package with certified PDFs
Engineered for High-Complexity Clinical Research Specialties
Pre-configured protocol matrices, RECIST 1.1 tracking, and endpoint assessments tailored for the world's most demanding clinical specialties.
Oncology & Immunotherapy
RECIST 1.1 tumor burden scoring, biomarker subgroup stratification, chemotherapy day-care infusion synchronization, and ANC/platelet gating.
Cardiology & Medical Devices
Longitudinal 12-lead ECG and 2D-Echo endpoint uploads, NYHA functional classifications, telemetry integration, and device implant registry tracking.
Neurology & CNS
Mobile digital seizure diaries via WhatsApp, cognitive batteries (MMSE, MoCA), EDSS scores for Multiple Sclerosis, and caregiver proxy reporting.
Vaccines & Infectious Disease
High-volume enrollment workflows, reactogenicity electronic diary reminders, cold-chain temperature telemetry, and biospecimen blood draw custody.
Simulate Your Clinical Trial Speed & Coordinator Time Savings
Adjust your study parameters below to see estimated coordinator data entry reductions, recruitment acceleration, and trial cost savings.
Why Modern Clinical Sites Choose ReyanLabs CTMS
See how ReyanLabs outperforms outdated legacy EDC tools and disconnected Excel spreadsheets.
| Feature & Capability | Reyan Clinical Trials™ | Legacy EDC / CTMS | Excel & Paper Binders |
|---|---|---|---|
| Direct Hospital EHR eSource Sync | Automated HL7/FHIR Sync (Zero double entry) | Manual Double Data Entry Required | Paper Charting & Manual Typing |
| Participant Mobile Engagement | Native WhatsApp & Web (Zero app download) | Third-party app or SMS only | Manual Phone Calls by Coordinators |
| FDA 21 CFR Part 11 eConsent | Built-in with Comprehension Video & Quizzes | Costly separate add-on module | Paper Informed Consent Forms |
| Protocol Tolerance Window Management | Automated ± Day Calculations & Calendar Locks | Static dates without automated alerts | Manual Coordinator Calendar Calculation |
| Pharmacovigilance & 24h SAE Escalation | AI CTCAE triage & automated DSMB dispatch | Manual data entry by safety staff | Fax / Email Paper Incident Forms |
| Audit-Ready DIA eTMF Vault | Included with 1-click inspection export | Expensive third-party eTMF integration | Physical Physical Ring Binders in Storage |
| Study Setup & Deployment Timeline | 5 to 10 Business Days | 8 to 16 Weeks Custom Coding | Ad-hoc spreadsheet creation |
Built to Withstand the World's Most Rigorous Audits
Engineered from the ground up for strict alignment with FDA, EMA, MHRA, and CDSCO regulatory mandates.
Cryptographic audit trails, non-repudiable electronic signatures, system access controls, and operational system checks.
Comprehensive investigator oversight, risk-based monitoring enablement, and verified data integrity standards.
AES-256 data encryption at rest, TLS 1.3 in transit, strict de-identification rules, and patient data rights controls.
Compliant with Indian New Drugs and Clinical Trials Rules, audio-video consent verification, and Ethics Committee reporting.
Everything You Need to Know About ReyanLabs CTMS
Have questions regarding clinical site onboarding, EHR bridging, or regulatory compliance? We have answers.
What is Clinical Trial Management Software (CTMS), and how does ReyanLabs differ?
A Clinical Trial Management System (CTMS) is enterprise software used by research sites, academic medical centers, sponsors, and CROs to plan, coordinate, and track clinical research studies. Unlike legacy CTMS platforms that act as isolated administrative spreadsheets, ReyanLabs bridges the gap between the clinical hospital EMR and clinical research operations. We provide native EHR-to-EDC eSource data capture, conversational WhatsApp participant retention, 21 CFR Part 11 eConsent, and real-time pharmacovigilance safety triage in one unified platform.
How does the direct EHR eSource integration eliminate double data entry?
In traditional clinical trials, study coordinators must manually transcribe patient data from the hospital EMR into an external EDC system—introducing transcription errors, query backlogs, and coordinator burnout. ReyanLabs natively connects to hospital EHR, LIS (Laboratory Information Systems), and PACS imaging via HL7 FHIR and secure APIs. When a trial participant undergoes routine vitals, lab work, or consultations, the validated data flows directly into the study eCRF, saving hundreds of coordinator hours per trial.
Is ReyanLabs CTMS compliant with US FDA 21 CFR Part 11 and ICH GCP guidelines?
Yes, fully. ReyanLabs is engineered to meet and exceed FDA 21 CFR Part 11, ICH GCP E6(R2) & E6(R3), HIPAA, EU GDPR, and CDSCO New Drugs & Clinical Trials Rules (2019). The platform includes immutable cryptographic audit trails, dual-authentication digital signatures, rigorous role-based access controls, automated data backup with AES-256 encryption, and full electronic record versioning.
How does the platform prevent clinical trial protocol deviations?
Protocol deviations—specifically missed visit windows, unauthorized dispensing, or skipped safety assessments—are the leading causes of regulatory citations and study delays. ReyanLabs features an intelligent protocol matrix calculator that automatically computes allowable visit windows (+/- days), generates automated WhatsApp visit reminders with fasting instructions, and locks eCRF data entry if procedures are attempted outside protocol boundaries without PI sign-off.
Can ReyanLabs assist in patient recruitment for hard-to-enroll clinical trials?
Yes. Slow recruitment delays 80% of clinical trials. ReyanLabs AI Candidate Matching scans your institution's historic and active EMR patient records, analyzing doctor notes, pathology results, genomic flags, and comorbidities against complex inclusion/exclusion criteria. Coordinators receive a pre-screened list of qualified candidates with match percentages and can initiate automated WhatsApp invitations with a single click.
Does ReyanLabs support decentralized (DCT) and hybrid clinical trials?
Yes. ReyanLabs supports fully decentralized and hybrid study models. Participants can complete 21 CFR Part 11 eConsent from home, log daily ePRO/eCOA symptoms and medication compliance via mobile WhatsApp chat without downloading an app, receive video consultations from investigators, and have laboratory samples collected through mobile phlebotomy integration.
How quickly can a new clinical trial protocol be configured and launched?
While legacy systems often require 8 to 16 weeks of expensive database programming, ReyanLabs modular study design templates allow research coordinators and CRO teams to set up a full protocol—including eCRFs, visit schedule matrix, inclusion/exclusion criteria, and eConsent forms—in as little as 5 to 10 business days.