Document Management System for Life Sciences Collaboration and Compliance
Oct 18 2023
Kivo has introduced Kivo GO, a unified platform designed to facilitate efficient collaboration for emerging life sciences teams while maintaining compliance and security.
Emerging companies managing new drugs and devices often find themselves navigating a complex landscape of trials and approvals, with stringent compliance requirements from regulatory authorities. Their Regulatory, Clinical, and Quality teams face significant challenges due to patchwork systems, manual processes, and unnecessary delays. A recent McKinsey study has quantified the cost of each day of delay at $1 million in lost potential revenue.
Toban Zolman, the CEO of Kivo, emphasises the critical importance of time-to-market for new treatments, both for the patients who need them and the companies sponsoring these innovations. Smaller Regulatory, Clinical, and Quality teams often lack the budget and administrative resources for large-scale enterprise solutions, leading to considerable time losses in managing documents and processes compliantly.
To address these challenges, Kivo GO offers a compliant collaboration solution equipped with integrated modules for functions such as RIM, eTMF, and QMS. Kivo GO offers several significant advantages.
Kivo GO streamlines collaboration for Regulatory, Clinical, and Quality teams, as well as partners and vendors, within a secure workspace, eliminating the need for complex integrations. Designed and priced with smaller teams in mind, Kivo GO provides an all-in-one solution at an affordable price, offering fast setup, lifetime updates, and real-time support. Every team member can access the same workspace and functional modules. Kivo GO places a strong emphasis on best-in-class security and compliance. It is Part 11 Compliant and Validated, requiring no local installation and offering built-in support for Single Sign-On. Kivo, as a fit-for-purpose, cloud-based system, is equipped with automatic guardrails and audit trails to ensure data integrity and compliance.
The launch of Kivo GO also marks the expansion of Kivo's Quality Management (QMS) capabilities, introducing new modules for SOPs, Controlled Documents, Training, CAPAs, Vendor Management, Audits, and more. These modules leverage templates, workflows, reporting, and project management features integrated into the Kivo GO platform.
Kivo GO is not limited to in-house teams. It extends its capabilities to vendors and partners, allowing CROs and regulatory consultants to standardise their process and project management. This enables them to work more efficiently and consistently with sponsor teams.
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