With an influx of technology on the horizon, now is the time for life sciences companies to modernize compliance systems. Pharmaceutical, medical device, and dental companies all have a stake in automating data collection, transparency reporting, and analytics. Organizations need to be able to easily look backward, so they can then plan effectively forward.
Finding the best way to modernize compliance was a highlight of “Analytics with Reference to Transparency and/or Monitoring,” a panel discussion I participated in during the 13th Annual GHC International Pharmaceutical and Medical Device Compliance Congress on April 9 in Athens, Greece.
The panel concluded that life sciences organizations should consider the following when innovating compliance:
Move Away from Manual Systems
Life sciences companies should consider automated systems for transparency reporting data collection with embedded analytics, the likes of which is available on MediSpend. This system allows for data to be compiled in the cloud. In this case, life sciences companies can normalize the data and access the data lake.
Customize the System
One of the concerns of those in the life sciences compliance sector is that buying an off-the-shelf, automated platform means purchasing a more generic product that satisfies the needs of many. But that’s simply not true. We build custom dashboards to assist companies and their specific needs. Then, they can use their unique data, along with CMS public data, to help them gain a competitive edge. The data also serves as a foundation for making decisions regarding HCP engagements.
Ask the Right Questions
The key to effective data monitoring, reporting, and analyzing is data capture. Of course, this also means validation of the data to mitigate any input errors. Once you are confident in the data, you have to make sense of it. There’s so much information that it can be overwhelming.
However, those who ask the right questions can quickly ascertain their objective. Perhaps, an organization seeks to identify outliers or risk indicators to weed out patterns of bad behavior. Others might want to look at performance indicators to determine best practices.
Users should look for patterns. Life sciences companies need a flexible system that allow them to see the data at different levels, so they can mitigate risk, conduct efficient transparency reporting, and utilize predictive analytics.
By nature, compliance officers are risk averse. Indeed, they should be cautious on a few fronts. To start, they must validate data. A compliance system should provide a means to check the accuracy of the compiled information. Second, compliance officers must consider privacy laws around the world, such as the European Union’s General Data Protection Regulation (GDPR). As a result, they must ascertain consent.
What many life sciences companies fail to realize is that privacy laws do not necessarily prevent them from analyzing certain data. After all, it is possible to anonymize an individual, so they cannot be identified within an automated compliance system. Finally, life sciences organizations should manage the permission levels of those who have access to see different kinds of data. This is manageable on an automated platform.
Look to the Future
Compliance systems have to evolve to respond to the latest in technology and the ever-changing regulatory landscape. For instance, the next advancement in technology will be built-in algorithms. Compliance officers have to stay on top of what’s coming next. Above all, life sciences organizations that have not already done so must take down first-generation legacy systems. They should move to more efficient, automated systems. They may have to transition region by region and employ additional training to ensure all stakeholders know how to use a modern compliance system. Life sciences organizations must remember this is a long journey. It will not happen overnight, but it will be worth it in the end because the future is upon us.