Pharma & Life Sciences is a highly regulated Industry. When it comes to data disclosures for regulatory as well as voluntary purposes, Pharma and CRO’s need to ensure that clinical data privacy & security never gets compromised. Yet Pharma and CRO’s continue to leverage manual approaches for data redaction, often leading to inaccuracies and sensitive data leaks. What is required is a Smart, Configurable, Automated and Customized solution catering to enterprise needs of data anonymization, while fulfilling regulatory requirements like EMA Policy 0070, EMA (EU) CTR 536/2014, Health Canada PRCI, others.
Regulatory Landscape
Pharma organizations are required to submit multiple documents as a part of their clinical trial application. The application package often varies depending on the type of trial and the regulatory requirements in the country of study. Following are some of the regulations impacting the clinical trials disclosures to Health Authorities -
Policy 0070 - In September 2023, the EMA relaunched the Policy on Publication of Clinical data for Medicinal products for Human use or Policy 0070. As part of Policy 0070, Pharma /Sponsors are required to anonymize all personal data that could identify patients participating in the trial. The policy also allows for the redaction of certain data that are deemed CCI, or “any information … that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.”
EMA No 536/2014 - The European Union Clinical Trials Regulation (regulation (EU) No 536/2014) is the legislation relating to the conduct of clinical trials of investigational medicinal products within the European Union. The CTR increases anonymization demands for Clinical Disclosure teams. Both an increase in the number of documents subject to redaction of CCI and a greater volume of personal data anonymization are necessary to comply when using CTIS (Clinical Trials Information System).
HC PCRI - Health Canada's PRCI (Public Release of Clinical Information) objective is to make anonymized clinical information in drug submission applications publicly available for non-commercial purposes following the completion of Health Canada's regulatory review process.
In addition to clinical trials specific regulatory requirements, Pharma companies also need to ensure data privacy & sensitivity in accordance with HIPAA, GDPR, CCPA/CCRA when sharing identifiable and confidential data across Public Registries and other voluntary data sharing initiatives. Same applies to sharing sensitive data across internal teams.
Market place for Data Anonymization
Data Anonymization process across the pharma Industry has predominantly been a manual process. But the recent regulatory changes have significantly increased the number of documents to be anonymized as well as the coverage of sensitive data variables across these documents. Hence these teams have started adoption of digital solutions. Some of the solutions available in the market are –
- Basic Automated Redaction Solution – Search and Redact capabilities. Suited for basic and low volume needs. Examples – Adobe Acrobat Pro, PDFElement, others
- Cloud based Redaction solutions – Cloud based Redaction services. Suited for large volumes. Cannot be customized. Examples - Redactable
- On Prem Solutions – Commercial off the shelf solutions which can be installed on workstations. Cannot support scale and are not customisable. Examples – Objective Redact, others
- SDK based Solutions – Document processing SDK’s (Software Development Kits). Needs integration or custom development. Examples – Apryse, PDFTron, others
- Integrated Redaction Solutions – Built in capabilities into Enterprise Content Management / Document Management solutions. Example – Veeva, SharePoint, others
Best Fit Solution for Pharma needs
Best on our domain capabilities and industry experience of driving Clinical Trial Data Disclosure projects, we recommend the following feature sets for an enterprise grade Data Anonymization Solution. We leave the decision of ‘Build v/s Buy’ to the pharma organizations -
- AI based Automation – Gen AI driven contextual, data & document redaction capabilities which support both – Automated and Human-in-the-Loop workflows.
- Configurable & Customisable – The solution should have business centric UX to define business rules. It should be easy to customize as per changes to CCI, PII, PHI guidelines & variables
- Anonymization technologies – Solution should be able to support quantitative and qualitative anonymization capabilities driven by document risk scores / thresholds
- Processing & Collaboration – Solution should enable collaborative workspaces, approval mechanisms, while support batch and real-time processing.
- Auditing – Have built in capabilities to ensure auditing and compliance
- Multi Format Support – Support text, images, TLF’s, audio, video.
- Integration – Integration capabilities with enterprise content management / document management systems like OneDrive, Box, Documentum, others.
Coforge has significant experience of digitally enabling Clinical Trials data disclosure initiative and transformations. If you are looking for any consultation /advice in this space, then feel free to connect.
