Clinical Transparency

 

Scale your internal transparency processes with risk-based quantitative anonymization and document redaction. Adhere to Health Canada and EMA regulations including PRCI, Policy 0070 and CTR. Support voluntary data sharing initiatives using RLS Protect and RLS service delivery experts.

Protect Patient Identity, Maximize Data Utility and Comply With All Transparency Regulatory Requirements

Medispend’s clinical transparency solution is the industry leading solution to automate an quantitative risk modeling, document redaction and anonymization process for your organization. With over 1.75 million pages and thousands of datasets anonymized successfully, our solution is purpose built for pharmaceutical Sponsors and CROs to support the growing demands of regulatory bodies, changes in regulations and increased volumes.

  • 65+ PRCI and CDP/Policy 0070 projects completed
  • Expert domain knowledge of regulator guidance
  • The industry leading clinical data anonymization solution
  • Advisory services

Meet and Exceed Regulator Expectations Using A Quantitative Data Analysis Approach

Traditional rules-based anonymization and redaction approaches do not measure risk of re-identification or data utility. Health Canada and EMA’s shared anonymization report (AnR) template requires input of key anonymized variables, risk threshold, risk of re-identification before and after anonymization and reference population methodology. Our solution and service teams will fulfill all AnR requirements for your project.

Promote Transparency, Data Sharing and Secondary Research

Balancing the need to protect the patient’s privacy with a need to maintain data utility is a difficult task without proper technology. Encourage innovation and secondary research by supporting transparency and data sharing initiatives with the confidence that patient data is protected and clinical utility is maximized. Enable secondary research bodies to benefit from the data while protecting patient privacy.

Replace Manual, Time Consuming Processes with Purpose Built Redaction Capabilities

Our solution delivers repeatable automated workflows to batch process, model and anonymize datasets and documents saving you large blocks of time. Avoid highly manual processes that are difficult to quality control. Save project specific searches, identify personal data variables and confidential information on multiple documents simultaneously. Systematically report on all confidential information justifications for audit and internal awareness.

Experience Matters: Training and Process Best Practices

Medispend provides an extensive range of documentation and training modules that help organizations transition from performing redaction and qualitative approaches to more advanced quantitative and automated anonymization processes. Medispend will support your transition and ensure a seamless submission process to the regulator(s):

  • Expert advisory services, including webinars and trainer-led tutorials around the latest de-identification techniques and regulatory changes
  • Technical support services, providing end-to-end, production implementation support
  • On-demand anonymization business processing outsourcing to support volume ‘spikes’ in your business

Medispend Solutions

Medispend offers a comprehensive suite of enterprise software and services for global regulatory and commercial compliance, medical affairs, field enablement and revenue management solutions designed to empower life sciences companies to grow their business compliantly.

Contact Us