Wingspan eClinical Blog

CTMS and eTMF: Six Tips for Achieving Value from Integration

 CTMS and eTMF are two critical elements of an eClinical platform.  Most sponsors and CROs consider them a critical part of their infrastructure, and hope that they can be integrated to provide a seamless flow of information and documents between them. Recently there...

Duplicate Documents: How to Avoid Seeing Double

If you have attended a conference presentation where an MHRA representatives spoke about TMF and TMF inspections, you will no doubt remember the speaker saying: Duplication of documents should be avoided. You can certainly appreciate the frustration they will feel if...

Data migrations, from an eTMF perspective – Part 2

Every company using an eTMF system has conducted (or soon will) a study migration project of some scale. Whether it is finding a way to move an entire paper TMF into their new eTMF system, moving a CRO-conducted study into their eTMF, or transferring studies from a...

Data migrations, from an eTMF perspective – Part 1

Every company using an eTMF system has conducted (or soon will) a study migration project of some scale. Whether it is finding a way to move an entire paper TMF into their new eTMF system, moving a CRO-conducted study into their eTMF, or transferring studies from a...

RFP Jumpstart Package

Wingspan Technology is pleased to offer an update to our popular RFP/RFP template.  This time we’re offering an entire package to help you with the challenging process of choosing the right eTMF solution. First, we’ve updated the RFI/RFP Template that we have provided...

New Resource: eTMF and Email Presentation

Wingspan’s slides about eTMF and email are now available for download. In this presentation, Kathie Clark outlines the guidance provided by the MHRA and EMA about documenting correspondence in eTMF. She uses two case studies to demonstrate how correspondence varies...

Is your eTMF in a State of Control?

ICH Q10 defines “State of Control” as “A condition in which the set of controls consistently provides assurance of continued process performance and product quality.”  ISPE provides another definition: “A condition in which a pre-defined parameter is observed to...

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