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13:04 ET Ensuring No Duplicates: Implementing Pulse Infoframe's GUID Model to Transfer and Link Patient Data from Study to Regis...

Nov 23, 2021

A novel GUID model meets GDPR requirements and ensures no duplication of patient data with the merger of international study data and patient registry data. News provided by Share this article Share this article LONDON and ONTARIO, Canada, Nov. 23, 2021 /PRNewswire/ -- Pulse Infoframe and the Loulou Foundation have announced a collaboration to leverage Pulse Infoframe's novel globally unique identifier (GUID) model to enable linkage of data from the CANDID clinical study, an observational endpoint study on CDKL5 deficiency disorder (CDD) recently announced by the Loulou Foundation. Ensuring No Duplicates: Implementing Pulse Infoframe’s GUID Model to Transfer and Link Patient Data from Study to Registry for Rare Disease This GUID model will be essential for the linkage of the CANDID study data to other data sets, particularly the international CDKL5 Registry, the single regulatory-compliant, international patient registry for the CDD community. Launched in 2017, the CDKL5 Registry is powered by Pulse Infoframe's healthie 2.0 evidence generation platform. The GUID will ensure that no patient data are duplicated, and it will enable follow-up data collection and outreach to families following the conclusion of the CANDID study. In addition, it will elevate the quality of the combined data set at the conclusion of this study. "For data to be of use to regulators and payors, they must be high-quality data," says Pulse Infoframe founder and CEO, Dr. Femida Gwadry-Sridhar. "We developed our GUID, which has been leveraged in a number of our real-world registries to date, to meet GDPR requirements and ensure that valuable patient data are not duplicated. This illustrates our ability to seamlessly combine multiple studies and registries in a manner that will meaningfully advance research to the benefit of patients." The GUID model was integrated into the patient data collection plan for the CANDID study, launched by the Loulou Foundation and sponsored by a pre-competitive industry consortium of seven companies:  Amicus Therapeutics ;  Biogen Inc. ; Elaaj Bio;  Marinus Pharmaceuticals, Inc. ; PTC Therapeutics, Inc.; Ultragenyx Pharmaceutical Inc. ; and  Zogenix, Inc. For more information on the CANDID study, please see the full-length press release  here . "We are excited to work with Pulse Infoframe on the integration of the GUID model into the CANDID study data plan," says Daniel Lavery, Chief Scientific Officer of the Loulou Foundation. "Linking of precious patient data from the CDD community is essential to advancing the clinical development of better drugs and eventual cures for CDD. The Pulse Infoframe GUID model permits this precise linkage of international data sets in a seamless, regulatory-compliant way that will help the entire CDD community." By harmonizing the data between the study and registry, researchers can access a broader set of data to answer more nuanced questions around disease progressions and expression, such as those based on geographic location, social determinants of health, and more. For drug development, linking data through a GUID impacts important regulatory, pricing, and reimbursement-related decisions. Over time, it becomes valuable for creating synthetic cohorts, which is especially useful in studying rare diseases, where large groups of patients can be difficult to find. For more information about the CDKL5 Registry, please visit  www.cdkl5registry.org . About CDKL5 CDKL5 stands for cyclin-dependent kinase-like 5, which is a protein whose gene is on the X chromosome. Mutations in it cause deficiencies in the protein level and severely affect brain development. About 90% of patients with CDKL5 deficiency disorder (CDD) are girls. CDD patients suffer from seizures that usually begin within the first few months of life, as well as from profound neurodevelopmental delay. Estimates suggest that one in 40,000-60,000 live births develop the disorder, making it difficult to study when compared to common diseases like cancer and heart disease. About the Loulou Foundation The Loulou Foundation is a private non-profit organization founded in 2015 to support the development of effective therapeutics and eventual cures for CDD. Through robust grant and directed research programs, the Foundation provides tools and resources to basic and clinical scientists to enable the development of disease-modifying therapeutics for CDD. These programs include support for pre-clinical, translational, and clinical research into basic CDKL5 biology, CDD disease mechanisms, and the proof-of-concept studies for gene therapy and genome modifying therapeutics. Visit  www.louloufoundation.org  for more information. About Pulse Infoframe Inc. Pulse Infoframe is a real-world evidence generation, health informatics and insights company that provides a technology and services platform designed to extract, curate, analyze and disseminate evidence-based conclusions that improve the quality of people's lives. Pulse Infoframe provides a full solution for registries, natural history studies and a range of other observational and regulatory grade studies. With provider relationships for patient access, Pulse Infoframe ensures that insights, evidence and publication results are disseminated across the ecosystem, including advocacy organizations, key opinion leaders, researchers and sponsors. Learn more at  www.pulseinfoframe.com . Press Contact: Nina Liu

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