New Delhi, 18 May 2022: APCER Life Sciences, the preferred pharmacovigilance (PV) services provider for pharmaceutical and biotech companies seeking compliance and safety management solutions across the product life cycle, has adopted Oracle Argus Cloud Service to deliver Integrated PV services.
Argus is a leading SaaS solution for processing, analyzing, and reporting adverse event cases originating for pre/post market drugs, biologics, vaccines, devices, and combination products. Its built-in automation, integration, and usability capabilities reduce manual tasks and maximize efficiency.
Emphasizing the alliance significance, Mr. Gopal Menon, Vice Chairman, APC Group said, “We take a strategic view of how technology enabled products and services can serve as a core foundation to our patient safety service offerings. Having Oracle as a trusted technology partner is a critical step towards achieving our vision of delivering cutting edge scientific expertise.”
“Argus augments APCER’s best-in-class technologies portfolio for delivering holistic and high-quality compliance for our customers, globally. The platform allows us the ability to offer choice of safety databases to biopharma companies looking to gain from scalable, secure, technology-driven scientific effectiveness,” said, Dr. Vineet Kacker, Managing Director and Global Technical Head, APCER Life Sciences.
“Industry-proven technology is pivotal to helping CROs provide services that meet the needs of their customers today and tomorrow,” said Henry McNamara, senior vice president and general manager, Oracle Health Sciences. “We are delighted that APCER Life Sciences has joined the growing number of CROs using Argus to optimize their safety case processing at scale and with the flexibility to meet the continuous regulatory changes we see within our industry.”
APCER has been processing safety cases on client-hosted Argus instances for years. This new relationship strengthens APCER’s Argus administrator and user expertise to transform:
- Global compliance towards drug, vaccine, and device regulations, including E2B(R3), E2B(R2), eVAERS, eMDR(R2), MIR, and IDMP.
- Automation for intake, case prioritization, field validations, safety communications, coding, listedness, narrative, case lock, submission, and archiving – reducing manual work significantly.
- Flexibility and customizability with out-of-the-box integrations for safety case intake, signal detection, and clinical trial solutions.
APCER Life Sciences (an APC Group company) www.apcerls.com:
APCER brings medicinal / scientific expertise through its healthcare professionals & physicians to address full pharmacovigilance requirements, with global offices and 800+ employees. APCER’s clients benefit from vast experience in regulatory submissions across 100+ countries and consultative approach towards audit /inspection readiness.