Documents for EMA Policy 0070 and Health Canada PRCI

The scale, efficiency and agility to meet your most stringent regulatory deadlines

Under Pressure

Anonymizing any personal information contained in your trial documents prior to their publication is now required by multiple regulators.

You may have only weeks to provide a regulator with an assessment of how this data will be anonymized. This holds true for EMA Policy 0070 and Health Canada PRCI, for example.

How can your team rise to the challenge?

Evolving beyond redaction

A common approach to anonymization has been to simply redact patient information, using a rules-based method. This approach, however, destroys data utility and limits transparency.

Redaction is becoming increasingly unacceptable to regulators and the broader research community.

See how Privacy Analytics can help your organization achieve true trial transparency

The benefits of risk-based anonymization

Our health data experts, in conjunction with Privacy Analytics’ software, anonymize your documents using a risk-based approach.
You get:

Rich Data

Data transformation methods preserve patient privacy while maintaining the highest possible degree of data utility. Data is transformed only where necessary.

Defensible Results

Our statistical approach to re-identification risk measurement provides a numeric result which can be easily demonstrated to fall below regulatory thresholds.


The most up-to-date, internationally recognized approach to anonymization helps you earn trust as regulatory bodies move away from accepting qualitative methods.

Client Success

  • 100% of a global sponsor’s dossiers were delivered on time and accepted by regulators.
  • Over 90 clinical study reports of varying formats and complexities –anonymized.

Still not convinced?

Learn more about the complex regulatory challenges that clinical trial sponsors face and how our methodology and expertise take this burden from your team’s shoulders.

Let’s talk

Let’s help you meet regulatory and privacy obligations while
fulfilling expectations for sharing clinical trial documents.

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Archiving / Destroying

Are you unleashing the full value of data you retain?

Your Challenges

Do you need help...


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.


Are you achieving intended outcomes from data?

Your Challenge

Do you need help...


Unbiased Results

Client Success


Situation:’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.


Do the right people have the right data?

Your Challenges

Do you need help...


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.



Are you empowering people to safely leverage trusted data?

Your Challenges

Do you need help...


Security / compliance efficiency


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

Do you need help...


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. 



Are You Effectively Planning for Success?

Your Challenges

Do you need help...


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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