The Value of the Cloud for Multivigilance

Michael Braun-Boghos
Senior Director Safety Strategy, Oracle Health Sciences

Today’s safety professionals face a seismic wave of pressures that include increasing caseloads, changing regulations, and shrinking budgets. These developments are forcing them to seek new types of solutions that reduce costs while remaining compliant with fast-changing industry guidelines and standards. The issues stretch across the whole lifecycle -- from clinical trials through post-marketing surveillance-- of the various medicinal products (drugs, vaccines, devices, combination products, etc.) covered under the multivigilance umbrella.

A Perfect Storm of Problems

Inevitably exploding case volumes, increasing costs in the face of flat budgets, and a growing number of available big data sources (social media, literature articles, medical records, clinical narratives, administrative claims, etc.) are making case processing, safety data analysis, and signal detection more complex than ever.

Against this backdrop, safety regulations from the FDA, EMA, PMDA, and other health authorities around the world are changing and becoming more stringent, and the pace of these changes, different in every region, has dramatically increased.

These constantly changing regulatory requirements have not only necessitated that safety teams upgrade their systems more often, but have also driven up case volumes. For example, some safety departments have experienced an astounding 50 percent (50%) annual caseload increase. Many organizations have outsourced as much case processing as possible; but now, reducing costs with new approaches, such as moving to the cloud and adopting artificial intelligence, has become a priority.

The Direction of the Safety Industry

Though some safety professionals have taken a cautious approach to adopting new tools, citing the sensitive nature of drug safety data, skepticism about the maturity of the technology, and the belief that safety practices are unique to each individual company, others see the potential value of solutions that are advanced enough to address such concerns.

These safety professionals are exploring ways to automate business process workflows using natural language processing (NLP), machine learning (ML), and artificial intelligence (AI) to gain new efficiencies. Organizations are also turning to the cloud to lower their total cost of ownership (TCO), increase IT productivity, and enable faster implementations. The cloud also makes regulatory upgrades easier, quicker, and less costly to implement. Leveraging AI and the cloud, safety analytics teams are also discovering new possibilities for knowledge generation and insight from the data collected and processed.

Results from a recent Informa Engage / Pharma Intelligence survey of 153 safety professionals revealed that 62 percent (62%) of the respondents are actively implementing or planning to implement AI for case processing, 63 percent (63%) upgrade their safety systems at least every three years to maintain compliance, and 58 percent (58%) have some or all of their solutions in the cloud, or are planning to move there within the next two years.

Choosing an Advanced Safety Solution

Safety organizations don’t want to worry about patching tech stack components, keeping system module versions compatible, scaling up servers and memory, and testing disaster recovery. They want to focus on benefit-risk analysis, not IT issues – this is enabled by the cloud.

The Oracle Safety Cloud, designed by safety, AI, regulatory, and technology experts working in consultation with health authorities, addresses privacy, security, compliance, automation, and budget issues. It integrates Oracle Argus, the world’s number one safety case management system, with Oracle Empirica, the number one safety signal management solution worldwide, for unified, end-to-end, multivigilance throughout the entire lifecycle of a company’s products.

Backed by the scientists at Oracle Labs, over 200 years of the collective experience of Oracle safety professionals, and Oracle’s $6.1 billion annual investment in new technologies such as AI and cloud infrastructure, the Oracle Safety Cloud delivers world-class security, proven automation success, and best practices configurations. It’s designed to overcome the current obstacles that plague the safety departments of sponsors, manufacturers, and CROs; and it can deliver efficiency gains of up to 51 percent (51%) when implemented with workflow automation and optimization.

Offering out-of-the-box integration, the Oracle Safety Cloud provides a unified, cloud-based, SaaS solution that automates adverse event processing, reporting and analytics, as well as signal detection and signal management, without sacrificing quality, security, or data privacy. In addition, the new Oracle Argus Extensibility Framework allows even large companies to move to the Oracle Safety Cloud, as it supports read/write support into Oracle Argus and facilitates custom extensions, integrations, reporting, and database objects in a secure fashion.

A Peace of Mind Choice

Why do companies choose the Oracle Safety Cloud? Because its proven capabilities provide them with peace of mind. The Oracle Safety Cloud makes it easier to stay compliant with ever-changing regulatory requirements such as E2B(R3), eVAERS, eMDR, IDMP, and GVP Module IX, among others. It makes it less costly to implement and upgrade safety systems. TCO comparisons have shown that by moving to the Oracle Safety Cloud, companies can gain a savings of 40 to 50 percent (40-50%) over a three- to five-year period. And, it’s supported 24/7 by a team of specialists worldwide.

“We are committed to developing new cancer therapies that harness the selective power of the immune system that seek out and destroy tumor cells,” said Michelle Kim of the GemVax & KAEL Group, a novel therapeutic cancer vaccine company in South Korea. “We rely on technologies like Oracle Argus Cloud to help ensure that we are making safety decisions, reduce risk and help ensure global compliance, so that we can focus on delivering therapies that will improve the quality of life of patients.”

Exploding caseloads, missed signals, the rapid pace of regulatory changes, the status of budgets, concerns about data quality – all of these pressures motivate the movement toward finding more efficient methods of safety case and signal management.  The Oracle Safety Cloud provides safety teams with an integrated suite of the world’s leading safety solutions to automate safety processes, reduce processing costs, detect risks early, and increase compliance, while ensuring multivigilance across the entire lifecycle of their products.

Are you struggling with safety data management?  Contact us for a conversation today.

Michael Braun-Boghos is Director of Safety & Analytics for Oracle Health Sciences.

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