Electronic Data Lifecycle Management (eDLM) is PharmaPros' strategic methodology for integrating and managing clinical trial data in a clear workflow that maps to the study protocol. In every engagement, PharmaPros applies this methodology while working side by side with sponsors and their vendors-helping to ensure that study timelines are on target and that all constituents understand the status of a trial. This unique approach is the foundation for all of PharmaPros' services-from custom consulting to the PharmaPros Dataflow Manager™ solution.

The principles of Electronic Data Lifecycle Management (eDLM):

> Capturing the operational intelligence that resides within the clinical data

This is the fundamental requirement of eDLM and the basis of its success. Within each protocol there are specific data collection requirements that relate to one or more of the planned clinical activities/events. Therefore, it is logical to expect one can determine if a clinical event has occurred simply by the existence of the required data deliverable.

> Managing trials based upon "expectedness" of data

Knowing that a clinical event has occurred is helpful, but unless one knows not only if, but when, it is expected, the ability to manage the trial to time lines and milestones is limited. If however, we map the schedule of events to an expected schedule of data collection, we can easily determine the status of the trial, not only by the presence, but the absence, completeness, and timeliness of the data.

>Embracing a paradigm shift away from the traditional silos of clinical development toward a holistic approach to managing clinical trials throughout the lifecycle of electronic data

This industry has struggled to improve processes and affect cost, time, and quality of trials in large part due to the traditional silos of clinical operations, clinical data management, biostatistics, etc. This has resulted in an industry stuck in time, resulting in a lack of ability to manage a trial along its intended continuum. As a result, no one has a complete picture, but only bits and pieces if information that don't fit back together as a whole until the end of the trial!

By breaking down the traditional silos, as well as more recent "systems silos", and looking across the continuum of the schedule of expected clinical events, one can finally manage a trial holistically - now armed with the necessary intelligence to act on time critical decisions, incorporate new best practices, and positively affect the time, quality, and cost of a clinical trials.

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