CHICAGO, July 26, 2017 /PRNewswire/ --
Over 200 Life Sciences organizations worldwide are adopting ArisGlobal's LifeSphere Safety™ multi-tenant cloud platform to achieve E2B(R3) compliance by November 2017 EMA deadline. Within that platform, ArisGlobal's LifeSphere Safety MultiVigilance™ solution leads the way in transforming safety case management through technology and regulatory expertise.
ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences, today announced that LifeSphere Safety™ is the first fully E2B R3 compliant cloud-based safety platform to provide regulatory authorities, biopharmaceutical companies, and contract research organizations full compliance with both E2B(R3) import and export functionalities to comply with the November 21, 2017 deadline of the European Medicines Agency.
Released on June 30th, the LifeSphere Safety platform complies with the latest domestic and global safety reporting obligations from FDA, EMA and PMDA for drugs, devices, cosmetics, vaccines and biologics.
"ArisGlobal is the first software provider to offer fully compliant E2B(R3) support, leading the market in meeting regulatory compliance at the same time as giving our customers reduced total cost of ownership through our pre-validated, multi-tenant platform, which future-proofs them against changing regulations, upgrade and maintenance costs," said Bharathish Rao, Director, LifeSphere Safety Services, ArisGlobal.
LifeSphere Safety MultiVigilance™ is based on a standardized implementation of industry standard practices (ISPs) for case processing and global regulatory compliance obligations.
The platform solution offers a number of key features to handle today's complex compliance pharmacovigilance requirements:
- Multi-tenancy deployment using ISP-configured screens reduces data entry time, thereby improving efficiencies. ArisGlobal's standard 'out-of-box' offering configuration based on ISP supports quicker set-up and addresses core processing needs thereby eliminating the need for any customization
- Powerful out-of-the-box reporting offers a wide variety of ad hoc, expedited and aggregate reports with no need of additional reporting tools, resulting in greater efficiency and better decision making
- LifeSphere services methodology enables rapid upgrades/migrations within weeks
- Optical Character Recognition leads to seamless automated data population into the fields from any structured data format
- Built-in quality scoring of cases and quality-monitoring mechanisms facilitate a better control of your service provider partner's quality performance
- Open architecture enables easy integration with regulatory, clinical, document management and medical information management systems for improved collaboration with off-the-shelf connectors/APIs to streamline integration
"LifeSphere Safety MultiVigilance is a prime example of how our LifeSphere Safety platform delivers significant benefits," said Sankesh Abbhi, Managing Director, ArisGlobal. "Case-processing time has been reduced by as much as 25%, as validated by an independent contract research organization. That level of efficiency, coupled with the appeal of scalable, transaction-based pricing, is very attractive to any life sciences organization, but especially to those faced with resource constraints. LifeSphere Safety MultiVigilance is also proving to be the preferred choice for a growing number of CROs who must meet the varying needs and requirements of multiple clients."
For more on LifeSphere Safety MultiVigilance, http://bit.ly/2tHNzPF
ArisGlobal is the visionary technology company that's transforming the way today's most successful Life Sciences companies develop breakthroughs, and bring new products to market. Our cognitive technology platform, LifeSphere, integrates machine learning capabilities to automate all core functions of the product lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, our cognitive platform delivers actionable insights, boosts efficiency, ensures compliance, and lowers total cost of ownership through multi-tenancy.