Clinical trials transparency initiates aim to foster innovation, drive development and increase trust through responsible data sharing. Last year’s introduction of the European Medicines Agency’s (EMA) Policy 0070 has placed a renewed emphasis on clinical trial transparency. Privacy Analytics’ solutions ensure trial sponsors can safely share their data and remain compliant with regulators.

Leaders in De-identification

Standards chart 1

Privacy Analytics provides a risk-based methodology that offers high data quality aligned
with globally accepted regulations, standards and guidelines for de-identification. Learn more about how using risk-based de-identification can not only make your organization a world leader in transparency initiatives, but also compliance and privacy.

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When it comes to anonymizing clinical study reports, redaction obliterates data quality. In the end, there is nothing left to support research efforts while ensuring compliance. There is a better way.
Redcation isn’t Enough

Enabling Transparency

Privacy Analytics Solutions Allow Trial Sponsors to

Privacy Analytics solutions allow trial sponsors to:

  • Rapidly initiate or expand clinical trial transparency initiatives with minimal upfront investments;
  • Ensure greater legal certainty with datasets that are certified to have a low risk of re-identification;
  • Meet existing standards and guidelines for best practices around de-identification;
  • Gain high quality data for expanded research;
  • Achieve more predictable costs for trials transparency initiatives;
  • Scale de-identification efforts and investments based on demand for data; and,
  • De-identify both IPD and CSR data using the same vendor and same risk-based approach.
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Clinical trial data will allow researchers to unlock more insights in treatment and care than ever before. In order to share this data, we must understand the risk of re-identification and ensure we use methods that are demonstrated to protect clinical trial participants’ privacy.
- Robin Jenkins, Senior Director Program Management, Clinical Trial Data Sharing, Sanofi

Anonymization for EMA Policy 0070

EMA

Under the EMA Policy 0070, manufacturers are required to submit anonymized versions of clinical reports to the agency, as well as a risk analysis report documenting how the risk of re-identification is considered sufficiently small. These documents will then be made publicly available under two different data sharing mechanisms. Many manufacturers are now trying to figure out how to meet these requirements for their new submissions – but look no further than Privacy Analytics. Our Clinical Trials Data and Document De-identification Service ensures compliance with EMA standards.

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