CRO

 

  • Historically, clinical trial data were collected at the clinical research site on pieces of paper designated as Source Documents.

 

  • Electronic Data Capture (EDC) is the current manifestation of the past process.

 

  • EDC allows users to enter, review, and analyze data in real time. The EHR allows users at a clinic or hospital to do the same for patient care data. The convergence of EDC and the EHR is inevitable and has the potential to improve the management of clinical research data and physician management of their clinical research operations.

 

  • While the EDC and EHRs are similar in both structure and function, as both focus on collecting patient data, adoption of both systems is still relatively modest. When properly designed, integrated EHR and EDC solutions should offer a convenient, cost-effective one point of data entry for the clinical sites to enter data.

 

  • As a result, in the future, both traditional paper and paper source documents could be eliminated,

 

  • The pharmaceutical industry will no longer focus on how well people can transcribe data from one medium to another; instead, companies will focus, in real time, on how well the sites are following the protocol and assuring a high level of data quality and patient safety.

 

  • LifeOnKey can provide CROs  with a middleware solution to be the  integration platform between EDC and HER  for their clinical trials, as well as PHR for the clinical trials participants, and a data center for the de-identified collective data for the Pharma.

 

  • LifeOnKey is an excellent platform to then help the Pharma company in their Phase 4 studies.

 

If you’re ready to hear more about LifeOnKey, contact the LifeOnKey business development team: bd@lifeonkey.com

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