REQUEST FOR PROPOSALS: Design, Development and Implementation of a Digital Research Ethics evaluate System for the Rwanda National Research Ethics Committee (RNEC)

1. Background

The Centre for Impact, Innovation and Capacity building for Health Information Systems and Nutrition (CIIC-HIN), coordinating the TRACE Project in Rwanda, on behalf of the Rwanda National Research Ethics Committee (RNEC), invites eligible firms to submit proposals for the design, development, and implementation of a Research Ethics evaluate System for RNEC and Institutional evaluate Boards (IRBs) in Rwanda.

The TRACE Project (Trial Regulation and Clinical Ethics Optimization), funded by the Gates Foundation, is supporting Rwanda in strengthening its ethics and regulatory systems through digital transformation and institutional capacity building. RNEC is mandated by the Ministry of Health to oversee the ethical perform of health research in Rwanda. The current platform used for protocol submission and evaluate has operational and compliance limitations, while most IRBs in Rwanda operate using manual or semi-digital processes. This has resulted in inefficiencies in submission, evaluate timelines, communication, monitoring, and reporting.

Following a comprehensive needs assessment that was conducted, RNEC intends to procure a qualified firm to design, create, and execute a Research Ethics evaluate System that will assist RNEC and IRBs through a shared application portal and a multi-tenant evaluate platform. The new system will enhance efficiency, transparency, compliance, reporting, and overall management of research ethics evaluate processes in Rwanda.

2. Objective of the Assignment

The objective of this assignment is to design, create, and execute a Research Ethics evaluate System that will assist the submission, evaluate and notification, approval, certification, and monitoring of research protocols for RNEC and IRBs in Rwanda.

The system will deliver a single shared online application portal for applicants and a multi-tenant environment that allows RNEC and each IRB to oversee their evaluate processes independently. The 

system will also assist digital payments, digital ethical clearance certificates, reporting, communication, document management, and integration with other relevant national systems where applicable.

3. Scope of Work

The selected vendor will be tasked with the design, development, implementation, and assist of a Research Ethics evaluate System that will assist the Rwanda National Research Ethics Committee (RNEC) and Institutional evaluate Boards (IRBs) from initial application, screening, evaluate and monitoring of the study.

The system shall be developed as a single shared online application portal for applicants and a multi-tenant platform that allows RNEC and each IRB to oversee their evaluate processes independently within the same system.

The system shall include, but not be limited to, the following modules and functionalities:

3.1 Shared Applicant Portal

A single online portal shall be developed for all applicants submitting research protocols in Rwanda. Applicants shall create and oversee a single account, submit applications, select the institution to which the application is being submitted, track application status, respond to queries, upload additional documents, and receive decisions, certificates, and notifications through the portal.

3.2 Submission and Application Workflow Management

The system shall assist online submission of research protocols and related documents, including new applications, amendments, renewals, progress reports, adverse event (AE) and serious adverse event (SAE) reports, protocol deviations, and study closure reports. The system shall assist document upload, completing the required forms, completeness checks, application tracking, resubmission, revision workflows and notifications. Each application shall be assigned a unique reference number. 

3.3 Integrated Digital Payment

The system shall assist application fee management, invoice generation, online payment integration, receipt generation, and payment verification. The system shall be integrated with an approved payment aggregator to assist multiple payment methods, including mobile money, debit/credit cards, and bank payments.

3.4 Review Management

The system shall assist administrative screening, reviewer assignment, protocol evaluate, reviewer comments, query management, evaluate tracking, and meeting preparation. The workflow shall be configurable to accommodate different evaluate processes for RNEC and each IRB, including full evaluate, expedited evaluate, and exempt evaluate where applicable.

The system shall incorporate AI-assisted screening capabilities to assist administrative pre-screening of submitted protocols. This shall include, but not be limited to:

• OCR-based detection of missing mandatory sections and required attachments prior to administrative screening.
• Smart validation to flag logical inconsistencies within submission content before the application enters the formal screening queue.
• Auto-classification of amendments as minor or major based on content analysis to assist efficient routing and evaluate.

3.5 Decision and Digital Certification

The system shall assist the recording of committee decisions and the automatic generation of decision letters and digital ethical clearance certificates. The system shall assist digital signatures and verifiable certificates, such as QR codes or verification numbers.

3.6 Monitoring and Compliance

The system shall assist post-approval monitoring, including submission of progress reports, amendments, adverse event (AE) and serious adverse event (SAE) reports, protocol deviations, renewals, and study closure reports. The system shall assist tracking of protocol status and compliance monitoring.

For adverse event and serious adverse event management specifically, the system shall assist:

• Online submission of AE and SAE / SUSARs reports by principal investigators and study teams.
• Automated notifications to RNEC administrators and designated reviewers upon AE/SAE submission.
• Workflow-based follow-up tracking, including assignment of evaluate responsibility, query management, and resolution recording.
• Configurable escalation pathways for unresolved or high-severity SAEs, with automated alerts to RNEC leadership.
• Status tracking of each AE/SAE report through its full lifecycle (Submitted, Under evaluate, Resolved, Closed).
• A complete audit trail of all AE/SAE submissions, reviews, follow-up actions, and outcomes.

3.7 Communication and Notification

The system shall assist communication between applicants, reviewers, and administrators, including queries, responses, alerts, reminders, and automated notifications at different stages of the evaluate process.

3.8 Reporting and Dashboards

The system shall deliver dashboards and reports for monitoring submissions, evaluate timelines including clinical trials, approvals, workload, revenue from fees, and other key performance indicators for RNEC and IRBs. The system shall assist data export in standard formats such as Excel, CSV, and PDF.

3.9 Public Registry and Transparency

The system shall include a public-facing component to publish approved studies and selected non-confidential information in line with transparency requirements and institutional policies.

3.10 Multi-Tenant IRB Management

The system shall be designed as a multi-tenant platform where each IRB operates independently with its own users, workflows, and access to its own applications and data, while RNEC maintains national-level oversight and reporting capabilities.

3.11 User Management and Role-Based Access Control

The system shall assist different user roles, including applicants, reviewers, IRB administrators, RNEC administrators, finance users, chairpersons, and system administrators, with appropriate role-based access controls.

3.12 Integration and Interoperability

The system shall assist integration and data exchange with other relevant national systems where applicable through secure APIs.

3.13 Audit Trail and System Logs

The system shall keep a complete audit trail of all system activities, including submissions, reviews, decisions, payments, evaluate timelines per type of studies and user activities, for compliance and accountability purposes.

3.14 Hosting, Security, and Data Protection

The system shall be designed for secure hosting in Rwanda in compliance with National Data Protection and Privacy Laws. The vendor shall propose system architecture, hosting requirements, backup mechanisms, disaster recovery, and security measures. The developer shall handover clean source codes to RNEC for its own management after the period of handover as it will be stipulated in the contract.

3.15 Search and Cross-Application Intelligence

The system shall deliver a robust search and cross-application intelligence capability accessible only to institutional users, including RNEC administrators and secretariat staff, IRB coordinators and chairs within their own institution scope, and reviewers within protocols assigned to them. 

This capability shall include:

• Full-text search across all application records, decisions, reviewer comments, and protocol documents within a user's authorized scope.
• Filtering by institution, date range, study type, status, principal investigator, timelines from submission to final decision and research area.
• Automatic surfacing of related applications when a new submission is opened, including same principal investigator, same institution, similar study area, and prior amendments or renewals.
• Cross-application intelligence to help reviewers detect precedent decisions, recurring issues, and research alignment across the portfolio.
• Enables identification of trends, recurring issues, and performance metrics across applications, supporting informed decisions. 
• Provides recommendations, anomaly detection, and automated linking of related submissions, boosting reviewer efficiency and consistency. 
• Ensures that sensitive information is only visible to authorized users and maintains an audit trail for compliance and traceability.

3.16 Data Migration

The vendor shall be tasked with the migration of validated historical data from the existing legacy ethics evaluate platform to the new system. This shall include data mapping, extraction, cleaning, transformation, validation in a staging environment, and production migration with RNEC sign-off. Only validated non-sensitive data shall be migrated. Legacy archives shall be retained for audit purposes.

3.17 Artificial Intelligence (AI) Integration

The system shall incorporate artificial intelligence capabilities to enhance the efficiency, accuracy, and analytical depth of ethics evaluate processes. AI integration shall be implemented in phases aligned with system maturity and data availability.

Phase 1 AI capabilities:

• OCR-based document pre-screening as referenced under Section 3.4.
• Smart form validation to detect logical inconsistencies within submission content.
• Auto-classification of amendments as minor or major based on content analysis.

4. Deliverables and Payment Milestones

Payment shall be made upon submission and approval of deliverables by RNEC and CIIC-HIN in accordance with the agreed milestones.

5. Implementation Timeline and Project Management

The assignment is expected to be completed within Three (3) months for system design, development, testing, and deployment, followed by six (6) months of post-implementation assist and maintenance.

The vendor shall propose a detailed implementation plan and timeline as part of their technical proposal.

Project Management

The vendor shall:

• Assign a dedicated project manager 
• perform stakeholder consultation workshops 
• deliver monthly progress reports 
• assist User Acceptance Testing 
• assist system deployment and training 
• deliver post-implementation assist 

Reporting

The vendor shall submit:

• Inception Report 
• SRS Document 
• System Design Documents 
• Development Progress Reports 
• Testing and UAT Report 
• Deployment/ Go-Live Report 
• Training Reports
• Final Project Reports
• Support Reports 

6. Non-Functional and Technical Requirements

The system shall meet the following requirements:

• Secure hosting environment 
• Role-based access control 
• Full audit trail 
• Data encryption 
• Backup and disaster recovery 
• High availability 
• Web-based system accessible via browsers 
• Mobile-friendly interface 
• API assist for integration 
• Data export (Excel, CSV, PDF) 
• Technical documentation and knowledge transfer 
• User Authentication mechanism (One Time Password (OTP), 2-Factors Based Authentication etc)

All source code and system documentation developed under this assignment shall become the property of RNEC.

7. Vendor Qualifications and Experience

Proposals will only be considered from vendors who meet all of the following eligibility requirements:

1. Legally registered company in Rwanda or in the region or with a demonstrable capacity to operate in Rwanda.
2. Qualification of the team: At least 2 software developers with Bachelor’s degree and above in Software engineering, computer Science, IT, or other related fields with proven experience in similar assignment.
3. For companies registered within the last five (5) years, the vendor shall submit CVs demonstrating that the proposed key team members individually possess at least five (5) years of relevant professional experience.
4. Relevant experience shall include proven experience in software development, health information systems, regulatory systems, or similar digital platforms.
5. Demonstrated experience in requirements gathering, gap analysis, system design, and full software development lifecycle delivery.
6. Demonstrated experience with system integrations and interoperability, including API-based data exchange within government or health sector institution.
7. Demonstrated capacity to incorporate AI or machine learning capabilities within digital platforms.
8. Experience in user training, and building internal digital capacity within government or health sector institutions.

8. Submission Proposal Requirements

All proposals must be submitted electronically in two separate files in PDF format 

File1: Technical Proposal

File2: Financial Proposal

Combined submissions will be disqualified.

8.1. Technical Proposal Contents

1. Cover letter confirming interest and eligibility.
2. Company profile and registration documents.
3. Understanding of the assignment: interpretation of the TOR and proposed approach.
4. Technical solution description covering system architecture, technology stack, security design, and hosting plan.
5. Methodology and implementation plan including phased work plan with milestones and timelines.
6. Team composition: CVs and roles of all key personnel.
7. Proof of at least two comparable completed/active projects with reference contacts.
8. A prototype design is encouraged in the submission.

8.2. Financial Proposal Contents

1. Detailed cost breakdown.
2. Payment schedule aligned to project milestones.
3. Annual maintenance and assist cost for Years 2 to 5.
4. Any assumptions or exclusions clearly stated.

All financial proposals must be submitted in RWF. Prices must be fixed and inclusive of all applicable taxes and fees.

Applicant with Financial proposal has arthimetic error will automatically be disqualified

9. Evaluation Criteria

Note: Pass mark to financial evaluation is 80%

10. Contract Duration

The contract duration shall be ten (8 months):

• 3 months of development 
• 5 months of maintenance and assist 

11. Submission Instructions

• If you meet the above requirements and are interested in learning more about the role and applying, please visit: https://ciichin.org/rfp-recruitment-of-sw-development-firm/
• All proposals must be submitted electronically to: administration@ciichin.org copying info@ciichin.org for reference. 
• The application deadline is Friday, 24th April 2026.
• Subject line must read: RFP CIIC-HIN/TRACE/2025/001 - [Vendor Name].
• Technical and financial proposals must be submitted as separate PDF or Word documents clearly labelled.
• Proposals submitted after the deadline will not be considered under any circumstances.

CIIC-HIN reserves the right to cancel this RFP, reject any or all proposals, and is not obliged to award a contract. CIIC-HIN will not be tasked with any costs incurred in preparing proposals.

Dr. Felix R. KITEMA

Managing Director

CIIC-HIN