Contract Research Orgs Services

Challenge

• Many contract research and manufacturing organizations are burdened with paper-based processes that slow down services and hamper sponsor satisfaction.
• Costly quality management platforms require custom engineering and constant revalidation.

Challenge

• Many contract research and manufacturing organizations are burdened with paper-based processes that slow down services and hamper sponsor satisfaction.
• Costly quality management platforms require custom engineering and constant revalidation.

Manage quality processes in one place

• Embed quality and GxP with an all-in-one platform that scales as you add new clients
• Unite people, suppliers, and change control across your entire business in real time
• Gain comprehensive visibility into your processes and proactively identify risks and opportunities

Focus on sponsor projects, not admin

• Get up and running fast with simple onboarding for everyone on your team
• Execute guided workflows for drafting, reviewing, approving and retiring documents
• Use templates and workflows that make CAPA management easy

Comply with any regulatory standard you need to

• Meet the requirements of FDA 21 CFR Part 210/211, ICH E6 (R2) and ISO 14155 with ease and consistency
• Capture and manage events like non-conformances, deviations and complaints and generate detailed reporting on training, audit trails, change control and more
• Drive closed-loop quality for all contract projects with end-to-end traceability