Electronic Data Capture

EDC Trials

Drug development companies are increasingly using technology to make clinical trials more efficient.  Increasingly challenged to maintain profitable growth, biopharmas are turning to Electronic Data Capture (EDC) to gain an advantage in clinical data management.  

Through electronic data capture - investigators, sponsors, clinical research organizations (CROs) and regulatory agencies achieve visibility of the clinical trial data sooner in the clinical trial process.  The earlier insight of EDC trials allows the sponsors of clinical trials to make key protocol decisions on safety and efficacy earlier in the clinical development cycle.

To fully leverage electronic data capture in a clinical trial, the sponsor organization must incorporate it into an enterprise architecture and clinical trial business process that provides for rapid clinical trial design, streamlined workflow definition, expedited discrepancy management and cross-application reporting that provides visibility into all aspects of a clinical trial.

To achieve this - sponsors need to look beyond electronic data capture and commit to integrating clinical trial management systems, drug supply systems, project planning and document management systems.  This is hard for anyone vendor to achieve - that is why it is critical that the architecture be vendor-neutral (and at times permit competing vendors) so that best-of-class software may be applied to the clinical trial process. 

By choosing the right vendors, with advanced integration capabilities - EDC systems are not isolated means for electronic data capture, but become an integrated component of the Clinical Trial Management Enterprise.

. eClipse offers the following Electronic Data Capture (EDC) services

Study Build: eClipse is experienced with the leading  Electronic Data Capture (EDC) products. eClipse can assist with study builds whether you have a license to an existing EDC provider or whether you need a license for EDC.
Business Process Definition : Implementing Electronic Data Capture (EDC) under a paper process will achieve results that are underwhelming.  To truly achieve benefit from EDC, you must change your business process.  With combined experience of over 30 years in EDC, eClipse consultants can help you achieve your desired results by tuning your business process to your chosen technology.
System Validation: In an increasing regulatory environment, why would you use vendor-supplied validation scripts?  To truly defend the use of a system under the vigor of an regulatory audit - your Electronic Data Capture (EDC) system of choice should be tested independently.  Veterans of a multitude of customer and regulatory audits, eClipse consultants will help you generate solid quality records.