Challenge Use Case: Late Stage Development & Periapproval StudiesNow more than ever, especially in rare disease populations, and as manufacturers look to add many different types of data from a variety of sources, finding a way to standardize data is critical to generate strong evidence of product safety and efficacy. Having a strong real-world infrastructure to accommodate all these sources, modalities, and connections is of great importance to your late stage development evidence-generation strategy.
Challenges exist when data with differing data elements from a number of sources (EDC, registries, claims, HCPs, pharmacy, lab, etc.) converge. Therefore, standardization of the data is paramount in generating evidence to benefit patients, especially rare disease patients, where population size is limited. According to the Framework for FDA’s Real World Evidence Program (Dec. 2018):
“[Registries’] fitness for use in generating RWE requires sufficient processes, such as those to gather follow-up information when needed, to ensure data quality, and to minimize missing or incomplete data”
“Another important challenge is the difficulty in connecting or integrating various data sources contributing information about an individual patient.”
UBC Pathways™ Mosaic – The UBC end-to-end data architecture solution provides comprehensive data collection, storage, security, anonymization, linking, and analytics for your most complex studies. Trace the patient journey, consolidate registry and clinical site data, identify payer and HCP behavior, safety signals, as well as patients and investigators for future projects with enhanced data derived by healthcare marketplace real-world datasets.
UBC Pathways™ Mosaic allows UBC to link existing data collected throughout the clinical study and during post-marketing research with multiple sources of disparate real-world data, resulting in unified, conclusive, standardized data. In addition, Mosaic addresses problems related to:
§ Data privacy laws such as HIPAA and GDPR (as well as local variants)
§ Anonymizing, linking, and matching of patients across varying data sources
§ Unification of differing data schemas
Through this real-world infrastructure framework and service, UBC successfully brings together operational, safety, and commercial data followed by comprehensive analyses by industry experts, to provide clients with real-world evidence & insights resulting in positive patient outcomes, peri- and post-approval.
For more information, please visit The UBC Mosaic Real World Infrastructure solutions, or connect with us here.