The Value of HQuantum in Observational Studies and Clinical Trials

Introducing standardization and terminology normalization in HIE facilitates improved clinical decisions, and better health outcomes, which in turn develops sustainability of the health care system.

These benefits are of particular significance in the clinical research domain, where a substantial percentage of costs arise from the data acquisition and analysis process. Healthropy proposes the HQuantum© solutions to health care peers involved in this domain e.g. clinical centres, hospitals, medical labs, CROs.

The domain of clinical trials is experiencing significant pressure to change practice. Historically, bio-pharma companies were encouraged to segregate patient related data collected by CROs during clinical trials. Then, in July 2013, Pharmaceutical Research and Manufacturers of America (PhRMA) joined with the European Federation of Pharmaceutical Industries and Associations (EFPIA) in the adoption of joint Principles for Responsible Clinical Trial Data Sharing (http://phrma.org/sites/default/files/pdf/PhRMAPrinciplesForResponsibleClinicalTrialDataSharing.pdf).

The EFPIA/PhRMA Joint Principles for Responsible Clinical Trial Data Sharing, implemented on 1 January 2014, have underscored the commitment of the pharmaceutical industry to disclosing clinical trial data. EFPIA members have made significant progress in developing processes for clinical trial data-access schemes, thereby translating principles into practice.

“In the future, clinical trial data will be enhanced by the availability of real world data from patient registries, hospitals and general practitioners. It is critical that European partners in research develop systems to maximise the potential of big data while protecting confidentiality of patient data, to further biomedical research.” (http://www.efpia.eu/mediaroom/264/70/Clinical-Trial-Data-Sharing-in-the-best-interests-of-patients-clinicians-medical-research-and-the-pharmaceutical-industry)

Healthropy’s proprietary technology, HQuantum© is the solution for implementing the “Interoperable” tier of the “direct data extraction” scenario proposed by the electronic Source Data Interchange (eSDI) group within the Clinical Data Interchange Standards Consortium (CDISC).

The four tiers of direct data extraction scenario proposed by eSDI (CDISC)