Electronic Consent (eConsent) for BA/BE Studies
Electronic Consents
Transform Informed Consent into a Secure, Digital Experience
Electronic Consent (eConsent) streamlines the informed consent process for Bioavailability (BA) and Bioequivalence (BE) studies by replacing paper-based documentation with a secure, compliant and participant-friendly digital workflow.
Designed specifically for Clinical Research Organizations (CROs), BA/BE centers, and pharmaceutical companies, the solution enables investigators to obtain, manage, and track informed consent electronically while maintaining regulatory compliance, complete traceability and data integrity.
Whether conducted onsite or remotely (where permitted), eConsent improves participant understanding, reduces administrative effort and simplifies consent management throughout the study lifecycle.
Challenges in BABE studies
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Manual Paper-Based Documentation:
- Managing printed consent forms across multiple studies and participants is time-consuming and prone to errors.
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Incomplete or Missing Signatures:
- Missing participant, investigator, or witness signatures can delay enrollment and create compliance concerns during audits.
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Consent Version Management:
- Protocol amendments often require updated consent forms. Ensuring every participant signs the latest approved version can be difficult with paper records.
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Time-Consuming Audits:
- Retrieving paper records, verifying signatures, and demonstrating document traceability requires significant administrative effort.
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Delayed Participant Enrollment:
- Manual consent review, signing, and verification increase the time required to enroll volunteers.
Our Solution
Neopharmtech's Electronic Consent (eConsent) solution digitizes the entire informed consent process, enabling CROs and BA/BE centers to obtain, manage, and maintain participant consent through a secure, compliant, and intuitive digital platform.
From participant registration to electronic signature and secure document archival, the system streamlines every stage of the consent workflow while supporting regulatory compliance and improving participant engagement.
The solution integrates seamlessly with clinical workflows, reducing paperwork, minimizing documentation errors, and providing complete traceability through automated audit trails.
Key Features & Benefits
Electronic Informed Consent
Feature: Create, distribute, review and manage study-specific consent forms electronically with secure digital signatures.
Benefit: Eliminates paper-based documentation and accelerates participant enrollment.
Secure Electronic Signatures
Feature: Maintain multiple versions of consent documents with automatic version tracking and controlled release.
Benefit: Ensures participants always sign the latest approved consent form.
Automated Audit Trail
Feature: Automatically record every consent-related activity, including document access, signatures, version changes and approvals.
Benefit: Provides complete traceability for inspections and audits.
Identity Verification
Feature: Verify participant identity before consent is signed using configurable authentication methods.
Benefit: Improves data integrity and reduces the risk of unauthorized consent.
Re-Consent Management
Feature: Automatically identify participants who require re-consent following protocol amendments and track completion status.
Benefit: Simplifies compliance with updated study requirements.
Centralized Document Repository
Feature: Store all consent documents securely in a centralized digital repository with advanced search and retrieval capabilities.
Benefit: Eliminates physical storage requirements and enables instant document access.
Why Choose eConsent?
Improve Regulatory Compliance
Electronic Consent (eConsent) is designed to support regulatory expectations by ensuring that informed consent is captured, managed, and maintained in a secure, controlled, and fully traceable digital environment. The platform helps organizations maintain data integrity, participant confidentiality and complete documentation throughout the consent lifecycle.
Our approach to improving regulatory compliance includes:
- Compliance with 21 CFR Part 11 Requirements
- Consent Version Control & Document History
- Participant Identity Verification
- Role-Based Access Control
Accelerate Participant Enrollment
Electronic Consent (eConsent) streamlines the participant onboarding process by replacing time-consuming paper-based consent workflows with a fast, secure and intuitive digital experience. By reducing manual steps and simplifying consent management, study teams can enroll participants more efficiently while maintaining compliance and data integrity.
Our approach to accelerating participant enrollment includes:
- Paperless Digital Consent Process
- Faster Review & Electronic Signatures
- Instant Access to Documents
- Reduced Administrative Delays
Reduce Administrative Burden
Electronic Consent (eConsent) eliminates manual, paper-based consent processes by digitizing document management, approvals, and participant signatures. This enables clinical teams to spend less time on administrative tasks and more time on study execution and participant care.
Our approach to reducing administrative burden includes::
- Reduced Printing, Scanning & Physical Storage
- Automated Consent Version Control
- Electronic Signatures & Timestamping
- Faster Participant Enrollment
Strengthen Data Integrity
Electronic Consent (eConsent) helps ensure the accuracy, completeness, and reliability of informed consent records by replacing manual paper-based processes with secure digital workflows. Every consent activity is recorded, controlled and traceable, reducing the risk of errors while supporting regulatory compliance throughout the study lifecycle.
Our approach to strengthening data integrity includes:
- Accurate Electronic Data Capture
- Secure Electronic Signatures & Timestamping
- Controlled Consent Version Management
- Role-Based Access Control
- Participant Identity Verification
Ready to Modernize Your Informed Consent Process?
Request a Demo Today and discover how Neopharmtech can help you transform informed consent into a seamless digital experience.
Neopharmtech India Private Limited
Madhava Nagar Colony,
Miyapur, Hyderabad, Telangana 500049