CloudLIMS hosted a complimentary webinar titled “Data Privacy and Other Clinical Data Management Challenges”. The webinar was presented by Marianne Henderson, Senior Advisor on biobanking to the National Cancer Institute’s (NCI) Center for Global Health and the Senior Advisor for Division Resources, Division of Cancer Epidemiology and Genetics (DCEG). We received an overwhelming response from the audience and got asked a number of interesting questions.
Drug discovery is an expensive and time-consuming process because it involves drug identification and several assays to ensure therapeutic safety and efficacy of the drug discovered. Clinical laboratories generate massive amounts of data on a day to day basis. Clinical data, one of the most valuable assets, is crucial for drug discovery, identification of novel biomarkers, and for disease prognosis. A good clinical data management system plays a pivotal role in preserving data quality and integrity, safeguarding Protected Health Information (PHI) of patients, thereby reducing the duration of clinical studies and in turn, the cost of drug development.
The webinar focused on the key clinical laboratory challenges including securely managing and accessing clinical data, safeguarding sensitive patient information, managing clinical tests and their results, following industry best practices and a number of regulatory guidelines such as HIPAA, EU GDPR, CLIA, GCP, etc. The webinar also discussed several ways to effectively address such challenges. One of the ways is to implement a good laboratory informatics solution. A Clinical LIMS helps in following regulatory guidelines and in ensuring data privacy and security through a number of ways such as audit logs, role-based access control, password controls, encryption and backup protocols, etc. The attendees asked several questions, such as how data quality can be improved, how organizations can address data loss due to silos, and what are the implications for informed consent with the advent of EU GDPR.
If you were unable to attend the webinar live or if you are interested to find answers to some of the present-day clinical data management challenges, watch the video. We are happy to discuss your clinical data management and regulatory challenges. Sign up to talk to our experts.