Clinical Data sharing for transparency is a hot discussion topic since the Policy 0070 and Health Canada publishing requirements have been implemented. Pharmaceutical companies need to redact their clinical documents to support submission for market authorization, but regulatory bodies are motivating sponsors to maintain higher data utility through anonymisation. It is not only regulatory groups, but also other associations/big pharmaceutical firms that are moving towards mandating of clinical data sharing.
For example, in July 2013, Pharmaceutical Researchers and Manufacturers of America (PhRMA) & European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies demonstrated commitment and shared complete Clinical Study Reports (CSRs) along with Individual patient data (IPD).
In June 2017, International Committee of Medical Journal Editors (ICMJE) introduced a requirement for data sharing statements of clinical trials before publishing any articles in journals abiding to ICMJE.
Clinical data such as dataset, clinical study reports, clinical summary reports and images may need sharing.
There are multiple scenarios for data sharing:
So, pharmaceutical companies have been submitting anonymized clinical reports to the EMA/Health Canada with redaction of any text meeting the criteria of personal information or Companies Confidential Information (CCI). EMA/Health Canada is also interested in alternative techniques for data anonymization, including replacement, generalization, date offsetting, etc., that have a more clearly established method for calculating quantitative risk of re-identification. Industry is also inclined towards using quantitative risk assessment for anonymization and maintaining the balance between risk of re-identification and data utility. Hence, with the release of phase 2 of Policy 0070, there is expected growth in anonymization as the industry recognizes the importance of data sharing. GENINVO understands this necessity and has developed Shadow™, a solution compliant with Health Canada, EMA Policy 0070 (Phase 1 & 2) and France’s MR001-MR004.
Our technical teams provide guidance and simplify the complexities of sharing data by employing efficient process generation techniques. Thus, enabling protection of confidential data during sharing data.
As a business that safeguards variety of data, we ensure that all information is accurately redacted and anonymized. Every organization has different requirements for data retention along with unique redaction needs. We put our customers at ease by properly handling sensitive information. At GENINVO, Quantitative risk analysis works on objective understanding as it relies on accurate statistical data whereas qualitative risk analysis works on expert subjective understanding as it depends on probability of an event and its level of impact. We provide actionable insights and help minimize uncertainty so the focus can be on high priority risks.
We professionally perform anonymisation services to anonymize each data set while meeting regulatory requirements, so the privacy of our data subjects and their personal information is protected. Risk assessment is one of the most critical and complex parts of risk management. Quantitative assessments provide clear data and determine threat levels as well as loss expectancies. We understand risk and provide the right technology to mitigate potential issues.
Data anonymization is crucial for clinical data transparency so personally identifiable data can be removed or encrypted to ensure the protection of patient privacy when data is shared. We provide access to data in ways that protects the confidentiality of research participants. Medical image data also needs to be anonymized along with datasets and documents. GENINVO recognizes that need and follows the DICOM (Digital Imaging and Communications in Medicine) format for transmission of medical images while preserving its utility. Anonymizing health care data while applying GDPR compliant techniques is not a one-off task, but we synchronize the complex processes for you and eliminate the various challenges of data sharing.
We at Geninvo have subject Matter experts with wealth of experience from the Life Science domains having in-depth knowledge and providing guidance to the Product development teams have resulted in Innovative oriented products like Shadow™, DocQC™, ApoGI™ etc.