Why is governance in life sciences so difficult?

The obstacle of governing clinical trial analytics, data management, and broader life sciences functions lies in the growing complexity of the data and processes involved. Manual governance approaches — whether for quality control or policy enforcement — are increasingly inadequate in keeping pace with modern needs. As regulatory demands become more stringent and data becomes more decentralized, governance must evolve to be a proactive, integral part of operations rather than a reactionary afterthought. This shift can enable life sciences organizations to focus on their primary mission: advancing healthcare and improving patient outcomes. In this blog, we will explore why governance and policy creation in life sciences are so challenging today and how you can overcome these challenges to prepare for what's ahead.

Top governance challenges for life sciences organizations 

Despite the potential benefits of advanced governance technologies, many life sciences organizations continue to experience significant challenges, especially related to outdated, manual governance models. Here are a few examples of the most common challenges:

• Ensuring that policies are uniformly applied across various processes in a timely manner, without causing interruptions, all the while securing 100% data quality validation.
• Delayed nature of quality control (QC) checks. In many organizations, QC checks are carried out at the end of a task or project, leaving little room for proactive problem-solving. This delay not only leads to potential risks, but also stalls workflows as teams must pause to address issues only after they’ve occurred.
• Building custom governance systems to meet organizational needs has also proven to be either costly, inefficient, or both. Bespoke solutions are difficult to maintain and often can’t adapt quickly enough to changing regulations or new data environments. As a result, organizations are stuck with outdated processes that slow down their ability to respond effectively.

The need for innovative governance solutions

Incorporating modern technology into governance provides life sciences organizations with the tools needed to tackle the complexities of compliance and data management. By automating key processes like policy enforcement and quality control, advanced governance platforms can reduce the inefficiencies and inconsistencies that arise from manual workflows. This shift frees up valuable resources, allowing teams to focus more on innovation and less on compliance tasks.

A key benefit of these solutions is the ability to gain real-time visibility into governance. Organizations can monitor compliance as it happens, adjusting on the go and reducing the risk of non-compliance. These governance frameworks are also scalable, allowing organizations to adapt as regulations and internal or external policies evolve.

In life sciences, where the stakes are high and timelines are critical, governance solutions transform policy enforcement from a burden into an enabler. By streamlining workflows and ensuring that policies are adhered to consistently, organizations can mitigate risks without creating bottlenecks.

Embracing automated governance

Domino Governance plays a pivotal role in helping life sciences organizations navigate these challenges mentioned above. By automating QC processes and embedding governance directly into Statistical Computing Environment (SCE) workflows, Domino Governance not only mitigates risks but also accelerates trial speed by reducing unnecessary bottlenecks. The ability to maintain compliance without sacrificing speed or flexibility will be a critical advantage in the life sciences industry. As more organizations recognize the value of automated governance, we can expect to see a significant shift towards solutions that turn QC from a necessary obstacle into a catalyst for success.

Key takeaways

Governance in life sciences often comes with a set of real-world challenges that directly impact organizational performance. From ensuring regulatory compliance to maintaining data integrity, the pressure to manage these aspects effectively is immense. Relying on manual processes for policy enforcement and quality control frequently results in inefficiencies, inconsistent data practices, and delayed project timelines. On the flip side, by leveraging technology-driven governance solutions, such as Domino, life sciences organizations can move from a reactive to a proactive governance model. Automation ensures policies are consistently enforced, risks are identified early, and data integrity is maintained across processes, helping organizations stay ahead of challenges.

Join us for an upcoming webinar to learn more about the evolution, future, and governance of SCEs.