PERSPECTIVES

Is It Time to Transform and Innovate Around Regulatory Intelligence?

2020-01-07


The largely manual process of collecting actionable regulatory intelligence is weighing down large and medium-sized life sciences companies. What’s needed is a modern cloud infrastructure that automates data collections and access and provides controls for security and data privacy requirements.

Life sciences organizations employ dedicated regulatory intelligence (RI) professionals who continuously monitor the landscape for pertinent news and information. It’s vital that these businesses monitor the news for relevant regulatory changes in the ever-evolving, globally oriented pharmaceuticals market.

Typically, the regulatory experts scour the internet, internal regulatory databases, and third-party intelligence subscription databases seeking actionable RI. This intelligence is then shared within the organization via email newsletters or posted in a common folder accessible via the company intranet.

Depending on its nature, each piece of intelligence may be actionable by different teams — and may need to be known by still other teams within the organization. The data may pertain to Regulatory Affairs procedural elements, competitive situations, due diligence requirements, strict regulatory compliance, or some combination of multiple categories.

As might be imagined, this highly manual approach is complex, error-prone and expensive. On average, large and medium-sized life sciences companies employ approximately 20 full-time equivalents (FTEs) yearly, spending about $800,000 on RI services, according to research from Boston Consulting Group. That figure doesn’t include subscriptions to databases, newsletters, blogs, etc. Based on RI collection solutions available today, we estimate the RI spend for the top 500 life sciences companies to be $3.3 billion — that’s 5% of the total regulatory affairs budget.

Moreover, given country-by-country regulatory changes, this approach doesn’t scale well, nor does it enable relevant information to be easily shared within an organization or among concerned parties within evolving ecosystems. It also offers limited opportunity for information re-use and keeps the organization in a reactive mode, therefore putting its regulatory strategy and product success at risk.

Tapping the cloud

To reduce costs and create much-needed operational efficiency, we suggest that life sciences companies consider using a validated (i.e. GxP-compliant) cloud infrastructure with the necessary controls for security and data privacy to comply with HIPAA, GxP and other regulations. Our proposed solution includes five key building blocks:

Figure 1

We believe the solution we’ve outlined could automate the following processes and more, easing the RI team’s manual burden:

  • Publishing periodic RI updates.
  • Identifying and communicating any regulatory mandates.
  • Dispatching alerts based on anomalies detected in safety data.
  • Providing recommendations and suggestions based on a user's past activity.
  • Supporting ad hoc secondary research requests.

The tool is filling an existing gap where RI is meaningfully integrated with internal knowledge, such that actionable insights are generated in an automated fashion to reduce cost and risk.

Looking ahead

Companies across industries are perpetually pushing to process higher volumes of information — in a shorter time period, amid shrinking budgets. The solution proposed here would help life sciences organizations navigate a world that is increasingly defined by boundary-less information sharing, in which key information must be consumed in real time to help businesses stay ahead of ever-changing regulatory requirements.

This article was authored by Cognizant’s Venugopal Mallarapu, Director and Global Market Lead, Life Sciences R&D Center of Excellence; Abha Gupta, Manager of Life Sciences Consulting; and Vibhor Madan, Senior Consultant, Life Sciences Consulting.

To learn more, visit the Life Sciences section of our website or contact us.