It is a fundamental precept that with the advent of any new technology, inherent challenges emerge along with apparent opportunity. This is no less true of the potential for “EDC” technologies, such as PDAs and E-CRFs, for the collection of pain data in clinical trials. Preliminary claims for the use of such technologies ala greater validity, increases in efficiency and shorter development cycle times are now being tempered by the reality of integrating such technologies into the complex clinical environments, especially where patient subjective assessments are used. Often with the rush of attempting to use such technology in “live trials”, the emphasis is on the use of the device(s) and key “environmental” aspects such as clinic/subject workflow integration, inter-organizational independence, patient /staff education can be given short shrift. This, coupled with novelty of the technology for many of the involved parties and ever shortening timelines, can be problematic, especially in the study of pain, where subjective assessments are the primary outcome. The purpose of the presentation is to discuss key aspects of EDC implementation in clinical environments and promote a dialog among the various stakeholders in the technology-clinical equation (technology vendors, sponsors, CRO/Investigators and regulatory authorities). Specifically, we will discuss a framework for examining integration issues for various clinical trial activities and potential roles for the stakeholders. Examples of tools utilized by SCIREX in integrating various EDC systems into CRO/clinical environments, such as Capability Assessments, Traceability and Responsibility Matrices and Clinical Process Mapping, will be presented. We will also pose what we think are salient questions that will need to be answered in a consensus fashion in order to integrate both existing and emerging “EDC” technologies successfully into the clinical trial environment, thereby realizing the initial intent of such technologies: increased efficiency and data quality while reducing development time. It is a fundamental precept that with the advent of any new technology, inherent challenges emerge along with apparent opportunity. This is no less true of the potential for “EDC” technologies, such as PDAs and E-CRFs, for the collection of pain data in clinical trials. Preliminary claims for the use of such technologies ala greater validity, increases in efficiency and shorter development cycle times are now being tempered by the reality of integrating such technologies into the complex clinical environments, especially where patient subjective assessments are used. Often with the rush of attempting to use such technology in “live trials”, the emphasis is on the use of the device(s) and key “environmental” aspects such as clinic/subject workflow integration, inter-organizational independence, patient /staff education can be given short shrift. This, coupled with novelty of the technology for many of the involved parties and ever shortening timelines, can be problematic, especially in the study of pain, where subjective assessments are the primary outcome. The purpose of the presentation is to discuss key aspects of EDC implementation in clinical environments and promote a dialog among the various stakeholders in the technology-clinical equation (technology vendors, sponsors, CRO/Investigators and regulatory authorities). Specifically, we will discuss a framework for examining integration issues for various clinical trial activities and potential roles for the stakeholders. Examples of tools utilized by SCIREX in integrating various EDC systems into CRO/clinical environments, such as Capability Assessments, Traceability and Responsibility Matrices and Clinical Process Mapping, will be presented. We will also pose what we think are salient questions that will need to be answered in a consensus fashion in order to integrate both existing and emerging “EDC” technologies successfully into the clinical trial environment, thereby realizing the initial intent of such technologies: increased efficiency and data quality while reducing development time.