Contributed Commentary by Michael Braun-Boghos

January 16, 2019 | Safety departments see themselves as invaluable protectors of patients’ health and well-being, while other departments often view these groups as necessary for compliance, but also cost centers that are expensive and slow down processes. So which view is correct? With the right strategy, safety departments can carry out their mission of multivigilance—monitoring and surveillance of different medicinal products including drugs, vaccines, medical devices, and combination products—while minimizing costs and speeding up activities that have traditionally been time drains.

Let’s look at how.

System Integration

Between the safety department and clinical R&D, many different applications are in use. These systems including electronic data capture, signal detection, and safety reporting systems were typically purchased separately without consideration for the bigger picture and have created a Frankenstein collection of point solutions that sit in silos and work independently of each other. A strategic approach, one where all corners of an organization uses integrated systems can save time, quicken processes, and reduce discrepancies. Here are four examples:

1. Integration of case management with signal management

Case management systems have a lot of adverse event (AE) information, while signaling systems have algorithms that can detect safety issues in various data sets. It’s really a no-brainer to connect the two, thereby increasing the chances of finding important product risks. Different algorithms can be used depending on the amount of cases in the data set, optimizing the chances of success while reducing time and effort spent switching between silo’d systems.

2. Integration of safety systems with analytics platforms

Traditionally, third-party, generic, reporting solutions have been customized to run reports on data in safety systems. Such customizations are often difficult and expensive to upgrade. A better approach is to use an analytics platform that’s integrated with the safety systems out-of-the-box, as this is optimized by the vendor and doesn’t break whenever there’s a new software release.

3. Integration of safety case management with clinical EDC

Although safety and clinical R&D are two separate departments, their processes are cross-functional. Unfortunately, their systems often remain siloed despite the connected business workflows. Integrating the safety case management system with the clinical EDC application makes double data entry obsolete, dramatically reduces the time for serious adverse events (SAEs) to reach the safety team, virtually eliminates discrepancies, and significantly simplifies reconciliation.

4. Integration of signal detection with clinical data warehouse

By having the signaling application directly access the full clinical trial data, product risks can be discovered earlier in the development process. This means that investment in unsafe products can be halted early, avoiding wasted efforts, unnecessary patient risk, and larger problems for the company downstream.

Cloud Deployment

The traditional approach to deploy safety systems on premise is starting to fall by the wayside. The cloud makes implementations and upgrades faster and easier. Upgrades are required more frequently than ever because regulations worldwide keep changing and becoming more stringent, so it’s important that they’re kept simple. The cloud means that safety department teams can let the technology vendor take care of the software and infrastructure, so that they can concentrate on multivigilance. And, since clinical systems are usually in the cloud already, having safety systems there, too, just makes integration easier and helps to ensure a smooth transition from pre- to post-marketing surveillance.

Automation and AI

The workflow for processing AE cases is typically full of inefficient manual steps. Adding fuel to the fire, caseloads are increasing up to an astounding 50% annually. Applications that offer built-in automation features can save the safety team a lot of time. Now artificial intelligence is also bringing automation to the next level by enabling even more manual work to be given to the computer. A strategy to focus automation and AI especially on “noise,” such as non-serious consumer reports allows safety departments to focus their valuable medical experts on the important cases that really matter, thus saving time and money.

Efficient and Effective Safety

Safety systems that are deployed in the cloud, utilize automation and AI, and integrate with other applications out-of-the-box allow multivigilance to be carried out in an efficient and effective fashion. Developing a strategy to move from “the way we’ve always done it” to next-generation technologies is key to taking advantage of these benefits.

Pharmaceutical companies are always looking for ways to cut costs. Turning safety reporting from a cost center to a cost saver is just one approach. Looking at eClinical systems that unify all processes, people and data is another.

Michael Braun-Boghos is Director of Safety & Analytics at Oracle Health Sciences. Michael has been working in medicinal product safety for 24 years. He spent 13 years in the European PV headquarters of Fujisawa and Astellas, ultimately leading the Safety Data and Quality Management group. Thereafter he joined Relsys, the developer of the Argus software, and finally came to Oracle Health Sciences with the Relsys acquisition in 2009. Currently he helps drive the product roadmap of the Oracle Health Sciences Safety Cloud and the Oracle IDMP Enterprise Foundation Suite. He can be reached at michael.braun-boghos@oracle.com.