Technology can help with many things, but we need to remember that humans created the technology, and humans make mistakes. When we create complex systems, it can be challenging to keep track of where everything is, how it should work, and how to spot errors that could cause harm to the business, or worse, to the patients.
Organizations are dedicated to ensuring that safety measures are in place for medical treatments and the medical devices and drug trials that come before and with those treatments. These organizations, such as the FDA, are in the business of monitoring, regulating, and controlling the innovations connected to the care being provided to patients, looking to identify and mitigate risk. One such case related directly to the innovations we are likely to see this year is decentralized clinical trials. The risks they are seeking in this instance are related to data quality. (1)
Hopefully, many life sciences organizations will do their part to control some of the risk themselves by leveraging trusted partners and essential skilled resources to help identify areas of complexity and exposure that need to be managed. Sadly, it’s not always the case, and regulatory measures have to be put in place. We can expect to match the levels of innovation and transformation this year; we will likely see numerous safety enforcements coming online this year for the life sciences sector, including cybersecurity and FCA risk. (2)
Transformation is upon us. It’s up to each organization to align their risk management operations to their innovation programs to ensure we keep what matters in sight: patient safety.
1 – “The case for cloud in life sciences,” McKinsey & Company, October 2021
2 – “What Healthcare Providers and Life Sciences Companies Can Expect for Enforcement in 2022,” Sidley, February 2022