Development of a Digital Contract and Site Management Platform for Clinical Trials

The client faces challenges with lengthy legal and contractual processes in clinical trials, resulting in operational delays and increased administrative overhead. They aim to enhance transparency and decision-making at the site level for budgets, contracts, and informed consent forms, thereby improving collaboration with Contract Research Organizations (CROs) and accelerating trial timelines.

A large pharmaceutical company seeking to optimize clinical trial operations and contractual workflows across multiple sites and CRO partnerships.

• Develop a tailored digital platform to streamline legal and contractual processes in clinical trials.
• Enable real-time, site-level decision-making for budgets, contracts, and informed consent documentation.
• Reduce process bottlenecks and operational delays associated with manual contract management.
• Improve transparency and collaboration with CROs and internal stakeholders.
• Establish a scalable, user-friendly system that minimizes training requirements and promotes adoption.
• Enhance compliance and security of sensitive clinical trial data.

• Workflow automation for contract approval, amendments, and renewals.
• Module for capturing and translating business processes into digital workflows.
• Dashboard for real-time tracking and status updates at the site and sponsor levels.
• Role-based access control to ensure secure handling of sensitive information.
• Integration of electronic signature capabilities for contract signing.
• Notification and alert system for pending actions and deadlines.
• Analytics and reporting tools for operational oversight and compliance monitoring.

• Existing enterprise data systems for patient and trial information
• Electronic signature platforms for contract authorization
• Financial systems for budget management and payments
• Regulatory compliance modules for audit trails

• System availability targeting 99.9% uptime
• Response time under 2 seconds for key user interactions
• Data security compliant with industry standards (e.g., HIPAA, GDPR)
• Ability to handle at least 100 simultaneous users without performance degradation
• Scalability to support expansion across additional trial sites and regions

Implementing this digital platform aims to significantly reduce contract onboarding times, enhance operational transparency, and improve trial efficiency. Expected outcomes include faster site activation, lower administrative costs, and improved compliance, ultimately accelerating clinical trial timelines and fostering stronger CRO partnerships.