At present, over 75% of all data acquired in controlled clinical trials, EMR systems, and related clinical environments is entered onto paper forms, starting a paper trail that imposes fundamental workflow inefficiencies and enormous costs. Replacing paper as a data capture medium is the "Holy Grail" of both the pharmaceutical services IT as well as the EMR industries. However, replacing paper has proven to be very difficult. Off-the-shelf Tablet PCs, Slate PCs, PDAs, and other handheld devices, designed for horizontal consumer markets, have proven useful for accessing information and simplified data entry, but do not approach the threshold for true utility in these application areas and are not an acceptable replacement for full-size paper forms.

Controlled clinical trials require the collection of vast amounts of information on each participant. Most information is initially recorded on paper, defining a "source document." Currently, all source documents such as screening evaluations, medical examinations, psychiatric rating scales (e.g. PANSS, CIBIC), concomitant medications, etc., consist of paper forms. Subsequently, every data point must be manually transferred to a second paper form, defining a Case Report Form (CRF). CRFs are summary documents created from source documents by clinical study coordinators to report to study sponsors and satisfy regulatory agency requirements. Manually creating a CRF (i.e. transcribing source documents manually) can take as much, if not more time, than the originating activity itself.

In controlled clinical trials, direct electronic data capture at the point-of-care (POC) eliminates the need for manually-created CRFs. Acquiring a clinician’s or researcher’s entries at POC not only achieves immediate registration and storage in the digital domain, but also enables a range of post-acquisitions operations such as structured query access, network-based data transmission, centralized archiving, and cross-enterprise data sharing. Further, computerized post-acquisition processing of an electronically-based source document greatly increases the efficiency of error identification and automatically creates a secure audit trail.

Electronic Data Capture (EDC) has enabled more rapid collection and review of clinical trial data. However, contemporary EDC has multiple limitations, the most important of which is the reliance on paper forms for primary data capture. Once data is captured onto paper forms, each entry (e.g. digital value) is manually typed onto a web form. Contemporary EDC can be labeled “paper-to-electronic-CRF” as the electronic capture process is, in reality, one large, critical step removed. Contemporary EDC is not to be confused with true POC data capture.

1. Replace paper forms in electronic medical records systems and clinical trials with cost-effective, FULL-SIZED, electronic equivalents and
2. Facilitate the integration of point-of-care, direct electronic data collection processes within a framework of comprehensive eClinical Solutions to streamline the overall clinical workflow for both controlled clinical trials as well as electronic medical records.