PACeR manages a cloud-based set of research software tools and databases that are open-source and provided free-of-charge for the uniform conduct of clinical research. Built on a set of standard data classification systems (see: CDISC, UPC, UMLS, as examples of PACeR structured data types) and structured semantic data control types, scientists and clinical investigators are able to construct, deploy across the web, manage and analyze any type of clinical, drug, device or outcome study in a CFR21.xx and HIPAA compliant manner. No knowledge of programming is necessary. PACeR’s clinical toolkit provides researchers with a free, fast, easy and powerful way to manage multi-lingual studies across global internet and mobile phone networks.
PACeR is standardizing clinical science through the rigorous management of data and its meaning. All PACeR participating scientists, clinicians and companies are provided with proprietary data vaults and pools that are controlled by the individual. But, every participating member captures their data in exactly the same format with the same semantic meaning to support the global integrity and standardization of data associated with scientific discovery.
“Because Clinical Research is a Different Enterprise Than Clinical Care & Requires A Different Toolset!”
The False Expectation of Electronic Medical Records (EMR)
In its first year of operation, PACeR performed an extensive analysis of the functionality of currently available EMR systems deployed within hospitals and physician offices to determine each major vendor’s capabilities to perform controlled scientific-method’s based clinical research. After extensive research and analysis a work group composed of representatives from hospital, pharmaceutical, technology company and medical professions determined that all current products on the market lack the functionality necessary for the conduct of controlled clinical research experimentation. All are primarily designed to record basic clinical and financial information for managing claims and to meet CMS “Meaningful Use“. They are designed to support drug, device or causal-associative epidemiologic research and lack the plasticity to capture the highly granular data necessary to support randomized clinical trials. Not only do these systems lack the ability to operate in a CFR 21.11 compliant regulatory environment, but they also lack the ability to capture and store the detailed types of data from clinical evaluations that routinely are found within drug, device and NIH sponsored research studies. EMR’s have the capabilities to support routine patient care and observational research, but are of little use for the recruitment of patients or management of detailed data collection that supports clinical research.
As a result and to support its mission to Advance Clinical electronic Research, PACeR developed and has deployed a cloud-based clinical research software suite that runs on a dedicated and secure set of social research networks that meets the needs of drug, device and clinical scientists who need to be able to longitudinally capture, store and analyze highly granular and standardized across time and location, clinical data in a semantically consistent way.
Build and Virtually Deploy Across the World-wide Web & Cellular Network
PACeR provides scientists with software to construct encrypted web and mobile research studies and for projects that require an added layer of protection, a highly secure, HIPAA-compliant clinical application study manager that runs across a PACeR Virtual Private Network. All tools are designed for incorporation with PACeR’s social research networks and are used to screen, recruit, enroll study subjects and remotely manage drug, device, meaningful use and comparative longitudinal outcome research .
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