Blog: Setting a New Standard in Safety Signal Analytics

ArisGlobal Announces the Launch of LifeSphere Clarity 

As a pharmacovigilance professional working in life sciences today, you know that the safety signal analytics process can present a myriad of roadblocks and obstacles. Safety signal validation and assessment—particularly for serial case assessments—is a time, cost, and labor-intensive process that slows down your operations, delays time to insight, and adds to risk physician burnout.

Now, there is a better way.

Picking Up Where Traditional Signal Detection Ends

The backbone of traditional signal detection includes statistical analysis across multiple data sets. Most methods focus on disproportionality, highlighting correlations between the suspect drug and an adverse event that are higher than expected. As any statistic professional knows, correlation does not imply causation. It is here that signal detection ends, leaving the causal analysis across a series of cases largely up to the individual physician. The physician must form hypothesis after hypothesis about the cause of the event and seek information to prove or discredit the hypothesis. Which possible causes are considered will be up to the individual physician.

LifeSphere Clarity brings an innovative technology shift to how signal data is collected, processed, and presented. Organizations will now be able to identify risk and derive insights faster, mitigating the downstream impact of signal issues both in clinical trials and post-marketing settings to improve patient safety, reduce risk, create a more efficient safety team, driving cost savings.

How efficient? Consider this: with LifeSphere Clarity, a physician could see in a literal instant that, for example, 76% of the 2,000 cases they are reviewing include a specific medical event, or more likely, a class of medical events, which are known by the broader medical community to cause the adverse event in question. That’s a powerful confounder that was uncovered in seconds, not weeks, all hypothesis-free. What’s more, this is the same for any physician looking at the case series, regardless of their clinical background, education level, or experience.

A Boon for Regulators

Once a signal is detected and analyzed, the sponsor will share the results with regulators (through SAR, PSUR), physicians (through dear doctor letters and Investigators brochure) and patients (change in protocol). If a CRO has been contracted to share information, they will also participate in conjunction with the sponsor’s regulatory department.

Being on the receiving end of these results as a regulator calls for the ability to quickly digest the information and make a judgment on the depth of analysis and appropriateness of action recommended. Often there is a lengthy back-and-forth required for the receiver to gain a full understanding of how the analysis was completed and what possible causes were and were not considered.

LifeSphere Clarity offers transparency and standardization of signal assessments, easing the burden of regulators who review assessments.

When a sponsor uses LifeSphere Clarity, regulators can be assured that every possible causal pathway surfaced by LifeSphere Clarity’s knowledge base was considered, not just the ones the physician formed their own hypothesis about in the timeframe allotted for the assessment. LifeSphere Clarity makes it easy to include standard statistics for not only the entire case series but for any stratification the physician has done during analysis. Causal pathway distributions can also be added to the results, all in a standard format.

Sponsors benefit alongside regulators from the ease of communication, spending less time discussing assessments and more time focused on the next breakthrough.

The Next Step of Life Sciences Evolution 

Having a robust data and analytics platform is no longer an option, it is a mandatory function for organizations within the life sciences industry. With LifeSphere Clarity, the power returns to the organization with better insight into the safety benefit-risk profile that can drive processing faster while also reducing costs. As the safety signaling model evolves, LifeSphere Clarity evolves alongside organizations to provide insights where and when they need them. The result is pioneering a new industry standard in safety signal analysis with a proven technology that powers the future of life sciences for more rapid growth and opportunity.  

Want to learn more? Speak to an ArisGlobal representative today about the groundbreaking edge that LifeSphere Clarity can provide for your organization.