Are You Ready for the EU Clinical Trials Regulation?

Are You Ready for the EU Clinical Trials Regulation?

Privacy Analytics’ Redaction-as-a-Service ensures fast, cost-effective clinical trial document submissions at scale

Reduces submission time from weeks to days using proprietary Mirage software – powered by natural language processing

On January 31st, 2022 the EU Clinical Trials Regulation (CTR) will come into effect, harmonizing assessment and supervision of EU-based trials through the Clinical Trials Information System (CTIS).

This will significantly affect how sponsors redact or anonymize clinical documents for regulatory submissions – and how quickly they need to get it done. Prior to 2022, sponsors were expected to publish clinical trial documents upon completion of the trial as part of their application for market approval. The impending adoption of EU CTR accelerates this data management timeline.

Sponsors must redact sooner

The new EU CTR includes requirements for many clinical trial documents, including clinical study reports, to be redacted as they are prepared for submission during the clinical trial life cycle.

Where initiatives like EMA Policy 0070 and Health Canada Public Release of Clinical Information (PRCI) focus on the publication of a subset of clinical documents, EU CTR aims to increase the scope of release to encompass all documents stored on CTIS. Personal and commercially confidential information must be protected, putting pressure on sponsors to proactively redact documents as they are submitted.

“Our clients are concerned about meeting redaction and anonymization requirements within increasingly tight deadlines in a cost-effective manner,” says Sarah Lyons, Head of Privacy Analytics.

Many sponsors who must prepare anonymized dossiers for publication under EMA Policy 0070 or Health Canada’s PRCI initiative lack the in-house resources for a full transparency solution. This challenge is exacerbated by unpredictable, retrospective requests from the public under PRCI. The timelines in the latter case can be very short, irrespective of the size of the package.

“These sponsors need a quick, responsive and cost-efficient solution that will meet requirements to get the documents successfully published,” Lyons says. “We listened to their concerns and developed Mirage software to make it easier for them to meet these regulatory demands.”

Get fast, cost-effective redaction

Find out how Redaction-as-a-Service reduces your time to submit clinical trial documents from weeks to days.

The technology delivering the speed you need

To help sponsors meet deadlines for EU CTR and other initiatives such as Health Canada PRCI and EMA Policy 0070, Privacy Analytics now offers Redaction-as-a-Service. In this engagement model, our team of over 100 clinical trial privacy experts leverage our fourth-generation document anonymization software called Mirage.

The latest release of Mirage unites our proven natural language processing technology with automated redaction. This extends Mirage’s existing statistical anonymization capabilities and provides customers with a seamless solution to meet all their evolving data privacy goals. This option is a good fit for sponsors looking to free their data experts to focus on more strategic tasks.

Alternatively, our clients can deploy Mirage software internally, providing their own data privacy experts with the technology necessary to rapidly complete all redaction tasks in line with regulatory requirements.

“Our clients can select the approach that best aligns with their unique business needs without sacrificing scale or quality,” Lyons says.

Get redaction that’s affordable

Privacy Analytics has been a trusted provider of clinical document anonymization services since EMA Policy 0070 was first launched in 2015. In that time, we have anonymized more than two million pages of clinical documents, supporting more than 40 successful regulatory submissions.

We understand the challenges our clients face in adapting to a constantly evolving regulatory environment. We use their feedback to inform our development strategies and to align solutions with their regulatory, financial, and business needs.

“The climate around data privacy continues to evolve, and regulators are holding organizations accountable for fast and thorough redaction of clinical documents,” Lyons concludes. “Redaction-as-a-Service allows pharmaceutical companies to protect patient privacy while minimizing costs.”

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