Blog: Transforming Life Sciences Agility on Both Sides of the Regulatory/Safety Sphere: A Year of Health Authority Successes

Today, more than 15 health agencies globally are using ArisGlobal LifeSphere solutions to streamline a range of pharmacovigilance and regulatory processes, all to the benefit of patients.

Following a very busy year, we’re thrilled to report that ArisGlobal’s LifeSphere platform is now in active use by more than 15 global health agencies, including some of the world’s largest authorities, for regulatory and/or safety purposes.

This is hugely beneficial for the industry, and for patients. It means all stakeholders are striving toward the same goal (more process consistency, rigor, agility, and enhanced patient outcomes). It also means the industry will get there twice as fast because progress is being made at both ends – at the side of the regulating body and of the marketing authorization/drug license holder (more than 300 MAHs globally use our LifeSphere suite of safety solutions today).

Here’s a high-level roundup of the latest work we’ve been doing that has huge potential to transform critical Life Sciences safety and compliance processes – and, most importantly, the patient experience.

Cementing Safety Vigilance 

In a pharmacovigilance context, the world’s largest health agency – the US FDA – is actively leveraging LifeSphere MultiVigilance as its core transactional safety system.

In fact, we’ve been a trusted technology provider to the FDA since 2015, actively helping the agency to deliver its Technology Modernization Action Plan from a safety/adverse event reporting perspective. In due course, all ICSRs (individual case safety reports) coming into the FDA will be processed using LifeSphere MultiVigilance; the system is expected to handle more than 3 million safety data transactions each year.

In addition to the FDA, three other global leading health agencies are currently applying the LifeSphere Safety platform to improve their ICSR processes in many ways.

Reinforcing Regulatory Rigor 

In the regulatory domain, 12 health agencies are leveraging our specialized reference data management solution, SPORIFY. This is making it easier for those authorities to match, maintain, sync, and integrate reference data, harmonize data across systems and geographies, and keep pace with real-time SPOR updates with the phased implementation of ISO IDMP standards.

We also worked with the EU Substance Registration System (EU-SRS) project team to help create the initial EU-SRS data set. The EU-SRS gathers scientifically-sound data on substances used in medicines.

We expect 2024 to be no less busy, continuing to partner with health authorities across the world to innovate and keep patients safe.