ArisGlobal, a producer of software solutions geared toward automation of core drug development functions for global life sciences companies, has introduced LifeSphere Regulatory. The cloud-based platform is designed to help users handle their entire regulatory management process in one integrated suite.
The platform consists of two key parts. The LifeSphere RIMS component is engineered to manage core regulatory processes. LifeSphere Publishing is a submissions management system that reportedly lets life-science organizations compile, publish, and validate regulatory submissions with support for all major global eCTD requirements.
The LifeSphere Regulatory platform also is integrated with LifeSphere EasyDocs, a cloud document management platform that provides a single source of reference for data and documents across research and development (R&D) business processes.
Pratyusha Pallavi, head of regulatory product Management at ArisGlobal, said handling regulatory issues can be a formidable challenge for many life-science organizations.
“Regulatory teams face many challenges, including keeping global teams aligned, managing growing regulatory complexity, and siloed information that slows the R&D process,” Pallavi said. “LifeSphere Regulatory solves these challenges by providing an intuitive and flexible suite that’s focused on risk reduction, collaboration, and efficiency.”
According to the company, LifeSphere Regulatory is built to provide efficiency through automation capabilities, as well as an approach that allows regulatory tasks to be handled in one simple interface. The platform reduces risk and stays up to date with the latest regulations via modern cloud architecture that delivers free upgrades and future-proof compliance. Notably, unlike other RIMS applications, LifeSphere Regulatory comes Identification of Medicinal Products (IDMP)-ready.
Giving key stakeholders across an organization access to the same documents and data reportedly helps keep teams around the world aligned. The company reports the LifeSphere Regulatory platform enables teams to work together without having to resort to time-resuming workarounds.
DIA 2020 presentations
ArisGlobal will be presenting at two sessions during DIA 2020
- Leveraging Automation in PV, Monday June 15th at 10:15 am: Emmanuel Belabe, associate vice president of safety at ArisGlobal will walk attendees through a view of how organizations are approaching and implementing automation.
- The Evolving Role of CTMS in Risk Management, Tuesday June 16, 10:45 am: ArisGlobal’s senior director of clinical Sondra Pepe will explore how the CTMS footprint is evolving with the advent of a quality by design approach to clinical operations.