• Kivo GO is a new, unified platform for emerging life sciences companies who need to manage documents and processes across their Regulatory, Clinical and Quality teams.
• Designed and priced specifically for smaller teams, Kivo offers a best-in-class collaboration and compliance solution – at a fraction of the cost of today’s ‘enterprise’ systems.
• Key features of Kivo’s expanded platform include Quality Management (QMS) capabilities, integrated project management, and intelligent process automation.

 Kivo, the intuitive Document Management Solution for life sciences, today introduced Kivo GO, a unified platform for emerging life sciences teams who need to work together efficiently across all functions while maintaining compliance and security.

The majority of new drugs and devices in development today are being managed by emerging companies working carefully – and in compliance with regulatory authorities - through trials and approvals. This requires close collaboration between their Regulatory, Clinical, and Quality teams – and valuable time is often lost due to patchwork systems, manual processes and avoidable delays. In fact, a recent McKinsey study estimates the value of each day of delay at $1 million in lost revenue potential.

"When it comes to advancing a new treatment, time to market is critical - both for the patients who need it and the company sponsoring it", says Kivo’s CEO, Toban Zolman. "However, these smaller Regulatory, Clinical and Quality teams often don’t have the budget or admin resources for an ‘enterprise’ solution - so they lose a shocking amount of time trying to manage documents and processes in a compliant way."

Kivo offers these teams a fit-for-purpose solution to accelerate their timelines with the launch of Kivo GO - a compliant collaboration solution with built-in modules for every function including RIM, eTMF, and QMS. Key benefits of the Kivo solution include:

• Fast, Simple, Intuitive: Kivo GO allows Regulatory, Clinical, and Quality teams to work together easily - including with their partners and vendors - all in the same secure workspace. Functional modules such as eTMF, RIM, QMS, an eCTD viewer, and more are all part of the same platform - no integrations required.

• Designed (and Priced) for Smaller Teams: Scaling teams no longer need to choose between patchwork systems or a big-budget solution. With Kivo, everything is included for one affordable price - fast setup, lifetime updates, real-time support - and everyone on the team can access the same workspace and functional modules.

• Best-in-Class Security & Compliance: Kivo GO is Part 11 Compliant and Validated - with no local installation required and built-in support for Single Sign-On. Kivo is a fit-for-purpose, cloud-based system with automatic guardrails and audit trails to safeguard data and keep everyone in compliance.

• New Quality Management (QMS) Features: Today’s launch includes the expansion of Kivo’s QMS capabilities, with new modules for SOPs and Controlled Documents, Training, CAPAs, Vendor Management, Audits, and more. These all leverage the templates, workflows, reporting & project management built into the Kivo GO platform.

Several Kivo customers - including Hyloris Pharmaceuticals and Ventus Therapeutics - have been taking advantage of these new features prior to public launch and finding significant value in the combined platform.

"We have been using the Kivo platform from the moment we needed a QMS and started our first regulatory submissions. Kivo was an easy choice and has proven to be the right choice." said Seppe De Gelas, Dir of Regulatory Affairs and Quality Assurance at Hyloris Pharmaceuticals.

"Their intuitive interface has been adopted quickly by the entire development team - allowing both the CMC experts and the clinical team to seamlessly integrate internal documents, as well as controlled documents from external parties. Kivo allows the regulatory team to easily build submissions for different applications and regions, and now also provides training modules for our quality documents, and an eTMF module for our clinical trial management."

The Kivo GO platform also extends to vendors and partners, such as CROs and regulatory consultants. By leveraging Kivo across their sponsor projects, these services providers can standardize their process and project management - working more efficiently and consistently with their sponsor teams.