21st Century Cures Act Passed – FDA place greater emphasis on use of RWD/RWE to support regulatory decision-making.
Major Technology Advances – AI/ML tools have enabled “semi-automated” image dating mining and iRWD operational efficiency.
Gold Standard - Clinical imaging is the preferred diagnostic test/tool for many disease identifications and tracking.
Life Sciences Experiencing Success – Imaging RWD usage can accelerate process(es), improve data diversity and product efficacy, and lower cost.
OneMedNet iRWD offers the best of advanced technology, clinical expert curation, and service. Medical imaging and associated clinical data is indexed at each network site using state-of-the-art AI/ML technology. This typically includes EHR, radiology, cardiology, lab, path and more.Our in-house clinical team performs intensive curation of the data ensuring that results meet the exact specification and requirements of Life Science Data Collection Protocol (DCP) – regardless of the complexity.
The data is fully de-identified using a multi-step quality control process and goes beyond PHI to include PII (personally identifiable information), SII (Site Identifiable Information), and more.
Importantly, Life Science users receive the data in the exact format that they require. No data sifting or manipulation is needed. The data is simply ready for use.
Importantly, OneMedNet has the unique combination of knowledge, tools, and experience to:
* Access and harmonize complete patient profiles across fragmented data silos
* Provide unmatched data accuracy and completeness
* Ensure the security and privacy of patients’ Protected Health Information (PHI)Imaging RWD is our singular passion and focus and no one does it better.
Advances in data sciences now enable the use of RWD to complement, reduce, and in some cases, replace clinical trials. OneMedNet provides insight rich data which meet the most demanding requirements for advanced analysis and regulatory submission – requirements that are analogous to prospective clinical trials.
This de-identified image-centric data is used in Discovery, Development, Regulatory Approval, and Post-Market Surveillance. OneMedNet iRWD enables the enrollment of the most under-served populations into clinical research which benefits all.
Clinical research organizations feel inspired to explore new clinical studies and R&D investment knowing the cost to do so is substantially less without sacrificing quality. De-identified imaging data is the future of accelerated healthcare research and development.
OneMedNet has partnerships with billion-dollar global Device companies as well as early-stage innovators. In all cases, our Device partners require very specific image centric RWD, often with multi-layer stratification. Sourcing and curating data to this level of specificity is very challenging.
However, OneMedNet has the knowledge, tools, and experience to:
Clinical studies are expensive, time consuming, and are often challenged with patient recruitment and effective participation.
OneMedNet iRWD enables data users to improve the speed and quality outcomes of clinical studies and product development, while minimizing complexity and reducing costs.
Our research and regulatory-ready data are used in Discovery, Development, Regulatory Approval, and Post-Market Surveillance.
Importantly, all data is received in the exact format specified.
No sifting or manipulation is needed.
The data is simply ready for use.OneMedNet iRWD enables the enrollment and participation of the most under-served populations into clinical research which is a significant benefit to all.
OneMedNet iRWD has repeatedly reduced timelines in AI algorithm development and validation.
Imaging data is only as good as its structure, categorization, and specificity.
With OneMedNet, you only get the data you need because we curate it to your precise requirements and data format – no matter the detail required.
We provide regulatory-grade data that stands up to the most stringent examination and diversity demands.
Since OneMedNet data remains native at network sites, a longitudinal dataset can be extracted and expanded for ongoing analysis.