Study Start-Up

Overview

Study Start-Up, or SSU, is the phase that prepares clinical trial sites for activation. It involves completing regulatory approvals, collecting essential documents, finalizing site readiness, and coordinating across multiple teams and systems—all while ensuring speed, accuracy, and compliance.

Traditionally, Study Start-Up is highly manual and fragmented. The following are some challenges encountered with these traditional methods:

• Manual Authoring of many complex documents, such as Study Protocol document, Form 1572, and many other regulatory submission documents, making it a highly manual, error-prone, and inefficient process, leading to risks of delays.
• High regulatory burden and country-specific variability. Each country has its own regulations, formats, and compliance requirements, making global Study Start-Up difficult to standardize and even harder to scale.
• Manual follow-ups with the document owners to complete their documents on time. Potential delays go unnoticed until it is too late, leading to delayed submissions to health authorities.
• Reliance on emails, spreadsheets, and disconnected systems to track site visit plans, and IMP green light milestones. As a result, many SSU processes become person-dependent— relying heavily on individual expertise and tribal knowledge.

Key Features & Functionality

The Study Start-Up solution uses Process Automation and Agentic AI to bring structure, intelligence, and transparency into the entire SSU lifecycle. It automates the generation of complex SSU documents, adapts to country-specific regulations through configurable business rules, and proactively manages milestones and risks using AI Agents—delivering faster, more compliant, and scalable Study Start-Up across global clinical trials.

By combining Process Automation and Agentic AI, SSU brings structure, intelligence, and transparency into the entire Study Start-Up lifecycle. Here are some of the highlights of the solution.

• Agentic AI for Document Generation
  • AI Agents for generating SSU documents, pulling data from various systems
• Process Automation
  • End-to-end Automation with flexible and dynamic workflows, leveraging existing systems
• Agentic AI for Process Monitoring
  • AI Agents to monitor potential delays, scalate, follow up and take actions
• Flexible Business Rules
  • Business Rules to configure Regulatory requirements
• Digital Signatures
  • Digital Signatures on approved documents for better auditability and compliance
• Process Analytics
  • Deep process analytics to identify process bottlenecks and area of improvement