ECONSENT SOFTWARE FOR CLINICAL TRIALS: YOUR DIGITAL INFORMED CONSENT PLATFORM
eConsent software for clinical trials
oomnia eConsent software is an electronic informed consent solution designed for seamless participant consent capture within a fully unified clinical research information system (CRIS).
Unified data capture
What is oomnia eConsent and how does it support electronic informed consent?
oomnia eConsent software is an electronic informed consent solution designed to streamline participant consent capture within a unified clinical research information system (CRIS). It enables participants to review study information and provide consent remotely, without requiring on‑site visits.
oomnia eConsent removes the need for separate systems by delivering a seamless, integrated digital consenting experience. This reduces manual oversight, minimizes site workload, and ensures teams have immediate visibility into participant consent status.
CLINICAL DATA
What is oomnia eConsent used for?
oomnia eConsent is designed to digitize and simplify the informed consent process in clinical trials, ensuring that participants receive, understand, and sign consent documents in a fully compliant and user-friendly environment.
oomnia eConsent supports:
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Unified consent experience across all study sites and participants, fully integrated within the oomnia platform
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Real‑time visibility of consent status synchronized instantly with study data
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Automated version control and consistency checks built directly into the platform
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Guided workflows that reduce site workload and minimize consent deviations
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Multilingual and multimedia support designed for global studies and diverse populations
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Continuous compliance monitoring through a single audit trail
Key Capabilities
Key capabilities of oomnia eConsent software
| Aspect | Modular eClinical system | Unified clinical trial software (oomnia) |
|---|---|---|
| System architecture | Separate eConsent software connected to EDC or CTMS through multiple integrations | Unified CRIS with consent workflows, participant records, and study documents stored in one connected environment |
| Participant access | External portals or PDF‑based processes requiring manual distribution | Direct access through the unified CRIS interface with mobile‑ and web‑friendly review and signing |
| Document availability | Consent forms must be uploaded, shared, or reconciled manually | Instant availability of the latest consent version across all relevant study modules, sites, and participant profiles |
| Consent content management | Vendor‑managed updates or limited customization | Configurable templates, embedded guidance, multimedia support, and centralized version control within CRIS |
| Participant engagement | Manual coordination for re‑consent, paper handling, or in‑person signatures | Automated reminders, guided steps for re‑consent, and remote signing options to support decentralized workflows |
| Integration with study database | Requires manual reconciliation or file uploads into EDC or CTMS | Automatically integrated with the unified study database, ensuring consistent consent status across all systems |
| Remote consenting | Limited remote options; often requires on‑site confirmation | Full remote consenting from any device, including document review, comprehension checks, and digital signatures |
| Device flexibility | Inconsistent support for personal devices; often tied to hardware or PDF workflows | Bring‑Your‑Own‑Device support with optimized experience across mobile, tablet, and desktop |
| Consent workflow flexibility | Hybrid electronic and paper consent handled manually or across separate systems | Support for hybrid consent workflows where electronic and paper consent can coexist while sites transition to digital processes |
Regulatory Readiness
Compliance and regulatory readiness
The oomnia clinical trial software is built to support regulated clinical research environments, helping biopharma teams maintain compliance, streamline documentation, and stay inspection-ready through every phase of the trial:
Aligned with GxP principles
Supports GxP-aligned processes across all clinical research operations
Supports compliance with 21 CFR Part 11
Fully compatible with 21 CFR Part 11 electronic records and signature requirements
ICH-GCP-compliant workflows and oversight controls
Workflows structured in accordance with ICH-GCP standards and oversight principles
GDPR-aligned data handling and privacy safeguards
GDPR-compliant data handling and privacy protection across all study environments
Built-in audit trails and full data traceability
Automatic audit trails and complete data traceability across all study operations
Validation documentation and continuous system compliance support
Clear validation documentation and ongoing support to keep the system compliant
How It Works
How oomnia eConsent works inside a unified clinical trial software?
Instead of working as a separate tool, oomnia eConsent software is built directly into the unified clinical research information system (CRIS). This means:
No separate consent platforms or external document portals
No manual upload, tracking, or reconciliation of consent forms
Shared data structures across participant records and study documentation
A unified audit trail for the entire consent journey
Elimination of cross‑system mismatches
Consistent terminology and document templates across study functions
Real‑time visibility into consent progress across all sites
Who This Is For
Who oomnia eConsent is for
oomnia eConsent software is designed for:
Sponsors seeking a compliant way to manage informed consent across global trials
CROs running decentralized, hybrid, or multi‑site studies that require remote consenting
Research teams looking to replace paper‑based consent workflows or disconnected document portals
Sites aiming to reduce administrative burden through automated version control and centralized tracking
Organizations prioritizing participant convenience with mobile‑friendly, remote consent options
The Platform
All clinical trial tools unified in one clinical trial platform
EDC software
Unified Electronic Data Capture system for compliant, real-time clinical data collection
CTMSCTMS software
Automated trial management solution designed to streamline study oversight
ETMFeTMF software
Digital workspace for storing, managing, and accessing trial master file documents
EPROePRO software
Real-time electronic patient-reported outcomes solution for patient data entry
ECOAeCOA software
Capture patient-reported outcomes, clinician assessments, and study data in real time without paper workflows
RTSMRTSM software
Randomization and Trial Supply Management system that automates treatment allocation and blinding in real-time
ESOURCEeSource clinical trials
Electronic source system that captures original site data in real time, fully validated and without manual transcription
Get Started
One unified view of your clinical trials
Move beyond disconnected systems to streamline data, minimize reconciliation effort, and maintain real‑time oversight from start to finish.
Talk to our teamFrequently asked questions
What is eConsent software in clinical trials?
eConsent (Electronic Informed Consent) software digitizes the informed consent process in clinical trials, replacing paper consent forms with interactive digital documents. Wemedoo's oomnia eConsent streamlines patient onboarding with multimedia content, multi-language support, and secure electronic signatures.
How does oomnia eConsent software improve participant onboarding?
oomnia eConsent software improves participant onboarding by enabling remote, mobile‑friendly electronic informed consent from any device. Participants can review documents, complete comprehension checks, and sign digitally without on‑site visits, making the process faster and more accessible.
Can participants consent remotely?
Yes. oomnia eConsent software supports full remote consenting from any device, including document review, comprehension steps, and secure digital signatures.
How does oomnia eConsent software integrate with the study database?
oomnia eConsent integrates with the study database through unified clinical trial software. All consent data automatically flows into participant records and study databases, and no manual uploads, reconciliation, or cross‑system checks are required.
How does oomnia eConsent software reduce site workload?
oomnia eConsent reduces site workload by eliminating manual document handling, removing the need for separate softwares, automating participant reminders, and seamlessly integrating consent status across all study modules.
How does eConsent improve clinical trial enrollment?
eConsent improves enrollment by making the informed consent process more accessible and engaging for patients. Interactive multimedia content helps patients understand complex trial information, remote consent enables participation from home, and the streamlined digital process reduces drop-off rates during the onboarding phase.
Is electronic informed consent legally valid?
Yes, electronic informed consent is legally valid and recognized by the FDA, EMA, and other regulatory authorities. oomnia eConsent complies with 21 CFR Part 11, ICH GCP, and EU Clinical Trials Regulation requirements, with complete audit trails and tamper-proof electronic signatures.
Can oomnia eConsent support multiple languages?
Yes, oomnia eConsent supports extensive multi-language options for global clinical trials. Consent documents can be presented in the patient's preferred language, ensuring proper understanding and compliance with local regulatory requirements across different countries.
How does eConsent integrate with EDC in oomnia?
oomnia eConsent is natively integrated with the EDC system, so consent status is automatically updated in the patient record. This eliminates manual tracking, ensures no data is collected before consent is obtained, and provides real-time visibility into enrollment progress across all sites.