Can You Comply Your Way to Greatness?

Can You Comply Your Way to Greatness?

An article by Sarah Lyons – Senior Director, Operations

I recently heard something that stuck with me:

“Nobody complies their way to greatness.”

An interesting comment, and a relevant one for all of us in the clinical trial transparency domain. But is there truth to it? Let’s take a closer look at what’s behind that statement.

The changing face of transparency compliance

Compliance is important, and the first step for many transparency programs needing to satisfy EMA Policy 0070 and new Health Canada guidance.

Transparency compliance, however, is not easy—as regulations continue to change, and tight deadlines create new demands for speed and scale. As Health Canada drives short turn-around deadlines and the EMA is poised to re-open, ensuring the capacity and capability to comply will remain front of mind.

But beyond meeting compliance obligations reliably, what can lead a transparency program to greatness?

Greater transparency builds trust and adds value

Beyond compliance, discretionary data sharing for research communities builds a transparent and trusting reputation, which contributes to brand-related outcomes like patient recruitment.

Even beyond transparency, there is great potential for anonymized trial data internally—as pharmaceutical companies look to innovate drug development. This means the same capabilities needed to meet regulatory requirements can be applied to other data sharing and uses, delivering high value to the enterprise.

Compliance is the starting point, but the realized value can be multi-fold.

Increasing value through anonymization

As an example, advancements in artificial intelligence and data science create new opportunities to innovate and differentiate drug development. Anonymization can unlock the value of clinical study data for internal analysis, research and innovation, with potentially high rewards for the enterprise.

A risk-based anonymization methodology preserves the utility of your data based on the context of use, delivering rich data for internal innovation. Because the same methodology and capability can be leveraged across a range of internal uses and external disclosures—regulatory, discretionary and strategic—Clinical Trial Transparency teams have an opportunity to deliver greater value to the enterprise.

Maximize ROI from your anonymization capability

Even if your focus is on compliance, the return on investment for a transparency program can be much greater if the same anonymization capabilities are leveraged to drive internal and external data sharing.

The risk-based, quantitative anonymization methodology promoted by EMA and Health Canada is consistent with emerging standards for anonymization around the world.  For example, a statistically defensible approach to de-identifying information is needed to achieve a level of anonymity under the General Data Protection Regulation (GDPR) and other regulations, such as the recent California Consumer Privacy Act (CCPA).

By getting ahead of the transparency curve, moving from redaction to anonymization, there is potential for economies of scale.

Share and innovate your way to greatness

Your takeaway? Consider external data sharing and internal innovation, such as those led by real-world evidence teams, when establishing your transparency delivery model and modelling your ROI.  Position your transparency team and function as a strategic corporate asset, bringing additional value to the enterprise.

Compliance can lead to greatness—with the right vision and follow-through.

Archiving / Destroying

Are you unleashing the full value of data you retain?

Your Challenges

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OUR SOLUTION

Value Retention

Client Success

Client: Comcast

Situation: California’s Consumer Privacy Act inspired Comcast to evolve the way in which they protect the privacy of customers who consent to share personal information with them.

Evaluating

Are you achieving intended outcomes from data?

Your Challenge

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OUR SOLUTION

Unbiased Results

Client Success

Client: Integrate.ai

Situation: Integrate.ai’s AI-powered tech helps clients improve their online experience by sharing signals about website visitor intent. They wanted to ensure privacy remained fully protected within the machine learning / AI context that produces these signals.

Accessing

Do the right people have the right data?

Your Challenges

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OUR SOLUTION

Usable and Reusable Data

Client Success

Client: Novartis

Situation: Novartis’ digital transformation in drug R&D drives their need to maximize value from vast stores of clinical study data for critical internal research enabled by their data42 platform.

 

Maintaining

Are you empowering people to safely leverage trusted data?

Your Challenges

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OUR SOLUTION

Security / compliance efficiency

CLIENT SUCCESS

Client: ASCO’s CancerLinQ

Situation: CancerLinQ™, a subsidiary of American Society of Clinical Oncology, is a rapid learning healthcare system that helps oncologists aggregate and analyze data on cancer patients to improve care. To achieve this goal, they must de-identify patient data provided by subscribing practices across the U.S.

 

Acquiring / Collecting

Are you acquiring the right data? Do you have appropriate consent?

Your Challenge

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OUR SOLUTIONS

Consent / Contracting strategy

Client Success

Client: IQVIA

Situation: Needed to ensure the primary market research process was fully compliant with internal policies and regulations such as GDPR. 

 

Planning

Are You Effectively Planning for Success?

Your Challenges

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OUR SOLUTION

Build privacy in by design

Client Success

Client: Nuance

Situation: Needed to enable AI-driven product innovation with a defensible governance program for the safe and responsible use
of voice-to-text data under Shrems II.

 

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