CO-AIAP SRS
Reimagining Trials Through AI Integration
Project Overview
Vision: A Unified Clinical Trial Ecosystem
The Clinical Operations & AI-driven Analytics Platform (CO-AIAP) is a unified, cloud-based Software-as-a-Service (SaaS) platform engineered to revolutionize the execution and management of clinical trials. It is a ground-up replacement designed to consolidate and replace the current fragmented landscape of disparate clinical technologies into a single, cohesive, and intelligent ecosystem. This application provides an interactive summary of the platform's Software Requirements Specification (SRS), designed to give stakeholders a clear and explorable view of the project's goals, users, and functionalities.
Reduce Trial Timelines
Leverage AI and automation to accelerate time-consuming processes like site selection and data cleaning, enabling faster access to new therapies for patients.
Enhance Data Quality & Integrity
Enforce CDISC standards at data collection, implement real-time validation, and utilize AI-powered anomaly detection for high-quality, "submission-ready" data.
Improve Operational Efficiency & Site Burden
Provide a single, intuitive, role-based interface to eliminate multiple logins and automate administrative tasks, allowing site personnel to focus on patient care.
Ensure "Audit-Ready" Compliance
Architected from the ground up to ensure continuous compliance with global regulations like GCP and 21 CFR Part 11, embedding controls into core functionality.
Provide Actionable, Predictive Insights
Move beyond data management to serve as an intelligence engine, leveraging AI/ML for enrollment forecasting, risk detection, and proactive decision-making.
Market Differentiators & Competitive Edge
The CO-AIAP directly addresses common user frustrations with incumbent platforms like Medidata Rave and Oracle's clinical suites, which often suffer from technological fragmentation, login fatigue, and redundant data entry. Our platform distinguishes itself by offering:
- Superior, Role-Based User Experience: Designed specifically to alleviate the "escape room" experience at clinical trial sites by providing a single, intuitive interface tailored to each user's needs, reducing administrative burden and login fatigue.
- Truly Integrated Data Model: Eliminates the need for redundant data entry by consolidating functionalities of EDC, CTMS, eTMF, and financial management into a single, seamless data ecosystem. This contrasts with disconnected systems that require repetitive information input.
- Deeply Embedded AI Capabilities: Moves beyond simple data collection and descriptive reports. Our platform provides predictive and actionable insights through AI and Machine Learning models, offering capabilities like AI-driven site selection, automated invoice processing, and real-time anomaly detection for proactive decision-making.
- "Audit-Ready" Regulatory Compliance by Design: Compliance with GCP and 21 CFR Part 11 is built into the core functionality, ensuring continuous adherence to regulations rather than being an afterthought or requiring extensive manual processes.
While existing solutions may offer some of these features, CO-AIAP's unique value lies in their comprehensive integration and the pervasive application of AI to solve long-standing inefficiencies, promising faster, higher-quality, and more cost-effective clinical trials.
Key User Personas
Click on a persona to explore their goals and frustrations.
Dr. Anya Sharma
Principal Investigator
A tech-savvy clinician-researcher focused on patient safety and scientific integrity.
David Chen
Clinical Research Coordinator
Site-level linchpin managing visits, data entry, and documentation.
Maria Rodriguez
Clinical Data Manager
Data-focused expert responsible for clean, compliant datasets.
Samuel Jones
CRA / Monitor
On-the-road auditor verifying site and data compliance.
Chloe Dubois
Clinical Trial Project Manager
Oversees scope, budget, and timelines for complex trials.
Core Modules
Explore functional areas spanning the clinical trial lifecycle.
A Unified and Intelligent Foundation
These requirements define the core, platform-wide functionalities that provide a unified and efficient experience for all users across the CO-AIAP system, addressing common pain points of fragmented legacy systems.
- FR-SYS-001 (Single Sign-On - SSO): Allows authenticated users to access all studies and modules with one set of credentials, eliminating login fatigue.
- FR-SYS-002 (Unified Dashboard): Personalized, role-based homepage with tasks and KPIs.
- FR-SYS-003 (Global Search): Cross-platform search bar with secure access filtering.
- FR-SYS-004 (Notification Center): Consolidated system alerts and study communications.
Key Metrics & Performance Targets
The platform is built on a foundation of high performance, robust security, and strict regulatory compliance. The following visualizations represent key non-functional requirements and access controls that govern the system's operational excellence.
Performance Targets (NFRs)
The system is designed for high concurrency and rapid response times to ensure a smooth user experience. These targets quantify the minimum performance standards.
AI-Assisted Site Feasibility (Simulated)
The integrated AI/ML model analyzes historical data to predict the best-performing investigator sites for new studies based on various criteria.
Role-Based Access Control (RBAC) Matrix
This matrix defines what actions each user role can take across the system's core features.
| Feature / Functionality | PI | CRC | CDM | CRA | CTPM | Admin |
|---|---|---|---|---|---|---|
| User Management: Create/Deactivate User | None | None | None | None | R | C,R,U,D |
| User Management: Assign User Roles/Permissions | None | None | None | None | R | C,R,U,D |
| Study Setup: Create New Study | None | None | R | R | C,R,U | C,R,U,D |
| Study Setup: Design eCRF | R | R | C,R,U,D | R | R | R |
| Study Setup: Configure Edit Checks | R | R | C,R,U,D | R | R | R |
| Study Setup: Configure Site Budget | R | R | R | R | C,R,U | C,R,U,D |
| Subject Management: Add New Subject Record | None | C,R,U | R | R | R | R |
| Subject Management: Perform Randomization | R | E | R | R | R | R |
| Data Management: Enter/Update eCRF Data | None | C,R,U | U (with query) | R | R | R |
| Data Management: Raise Data Query | R | R | C,R,U | C,R,U | R | R |
| Data Management: Answer Data Query | None | U | R | R | None | R |
| Data Management: Perform Medical Coding | R | R | C,R,U,D | R | R | R |
| Data Management: Lock/Unlock Database | A | None | E | None | A | E |
| Monitoring: Create/Submit Visit Report | None | None | None | C,R,U | A | R |
| Monitoring: Verify Source Data (SDV) | None | R | R | U (mark as verified) | R | R |
| Financials: View Site Payment Status | R | R | None | R | C,R,U | R |
| Financials: Approve Site Payments | None | None | None | None | A | R |
| Document Management (eTMF): Upload Document | R | C,R,U | R | C,R,U | R | R,U,D |
| Document Management (eTMF): E-sign Document | A | A | A | A | A | None |
| Legend: C = Create, R = Read, U = Update, D = Delete, E = Execute, A = Approve | ||||||
Regulatory & Data Standards Compliance
Compliance with international and national regulations, alongside adherence to industry data standards, is a fundamental architectural principle of the CO-AIAP—not merely an optional feature. The system is built from the ground up with specific, verifiable controls to ensure data integrity, authenticity, and traceability.
21 CFR Part 11 Compliance (NFR-REG-001)
Adherence to U.S. FDA's regulations for electronic records and electronic signatures.
- Immutable Audit Trails (NFR-REG-001.1): Secure, computer-generated, time-stamped, non-modifiable audit trails for every action (create, modify, delete) on electronic records, recording user, date/time, and old/new values.
- Compliant Electronic Signatures (NFR-REG-001.2): Cryptographically bound to records, requiring re-authentication, and clearly displaying signer's name, date/time, and meaning of signature.
- System Validation (NFR-REG-001.3): Comprehensive validation under a formal Quality Management System (QMS) to provide documented evidence of consistent, intended performance.
Good Clinical Practice (GCP) Compliance (NFR-REG-002)
Designed to inherently support and enforce ICH E6(R2) principles for ethical and scientific quality of trials.
- Facilitates strict protocol adherence.
- Protects rights and safety of human subjects (e.g., robust eConsent, safety reporting).
- Ensures absolute integrity of collected clinical data.
Data Standards Adherence (CDISC)
Rigorous adherence to CDISC standards for data interoperability, reusability, and streamlined regulatory review.
- CDASH Conformance (NFR-DATA-001): eCRF design and standard form library strictly conform to CDISC CDASH Implementation Guide for standardized data collection.
- SDTM Conformance (NFR-DATA-002): Data export functionality generates datasets conforming to CDISC SDTM Implementation Guide for regulatory submissions (e.g., FDA, PMDA).
- ADaM Conformance (NFR-DATA-003): Provides tools and structures to support creation of analysis-ready datasets conforming to CDISC ADaM Implementation Guide, with clear traceability to source SDTM data.
HIPAA Compliance (COMP-01)
The system's architecture, development practices, operational procedures, and data handling are fully compliant with all technical, physical, and administrative safeguards stipulated by the Health Insurance Portability and Accountability Act (HIPAA) Security and Privacy Rules for Protected Health Information (PHI).
- All PHI is encrypted at rest and in transit (NFR-SEC-002).
- Strict Role-Based Access Control ensures only authorized personnel access PHI (NFR-SEC-001).
- Comprehensive, immutable audit logs track all access and modifications to PHI (NFR-SEC-001.1, SEC-03).