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Scimcon’s people have more than twenty year’s experience working with life sciences companies — and been in ePRO since the beginning.
Our consultants are called on to define strategies for ePRO, assist in vendor and platform selection, achieve validation and support individual study UAT.
You can use our expertise wherever and however it’s needed, creating programmes from the ground up, or simply providing an independent pair of eyes in the UAT process.
We provide support at strategic or operational levels using skills and experience in three areas: Strategy, Testing, and Support.
Projects typically call on some but rarely all of these skills:
Strategy
Projects need real leadership to unite the range of participants and influencers and keep everything moving forward.
Scimcon project leads have the experience and the understanding to help shape the programme, steer its development and negotiate the difficulties that commonly impede progress.
Where we can help
Testing
There’s a big difference between testing to a specification and understanding the clinical domain.
Scimcon testing leads are familiar with all the challenges inherent in eClinical solutions as well as the practical and regulatory environment to deliver robust testing packages against a backdrop of tight deadlines and the need for low ‘in study’ defects.
As an independent organisation, our involvement removes the blind spot of vendor self-testing.
Study sponsors often ask their ePRO vendors to undertake the UAT scripting and execution, but it risks potential problems and lacks objectivity.
System creators are not always in the best position to spot technical issues nor to see things from the users’ viewpoint. They may know the system, but know less about users. And while guidelines account for vendor UAT, it is sponsors who retain accountability. Scimcon UAT removes these potential problems.
Where we can help
Support
It’s good to know that help’s available, but better to know how helpful it is.
Although vendors often provide support to users with software issues, a greater depth of support is often called for. The support we offer goes well beyond the helpdesk. We tackle all the challenges that arise (whether software, hardware, communications, or logistics to name a few), often managing complex issues that need coordination between the clinical site staff, sponsor study teams and vendor teams involved in a programme.
Our study support team is dedicated to getting to the root cause of complex issues and resolving them quickly and confidently, taking responsibility and owning the issues and documenting their path toward resolution.
While validation and UAT done correctly will reduce the number of in study issues, issues will still arise. Whether this is related to logistics of delivering device around the globe, errors in translation, site staff misunderstanding, revisions to ePRO functionality mid study.
Where we can help