ePRO Expertise

How we help vendors and sponsors

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.

Capability and capacity — we offer flexible resourcing for the skills and experience you need

We provide support at strategic or operational levels using skills and experience in three areas: Strategy, Testing, and Support.

Strategy

Providing leadership to shape and drive the programme forward

Testing

Ensuring compliance for the programme or its components

Support

Going beyond the helpdesk to follow up issues

Use us where it adds most value

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

  • Defining an ePRO strategy
  • Vendor assessment, selection, qualification and oversight
  • Platform validation approach and deliverables to study specific UAT procedures
  • Project leadership to manage individual, one-off ePRO implementations
  • Study specific ePRO planning, requirements definition, multi-level / multi-team communication, oversee rollout tasks from device logics to team training

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

  • Documenting ePRO standard operating procedures and study specific templates
  • Providing validation plans, requirements definition, test protocols and final reports
  • Creating study specific UAT protocols
  • Defining UAT requirements and risk assessment
  • Writing UAT scripts and traceability matrix
  • Executing UAT

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

  • Providing second line support to manage issues
  • Documenting issues, following up with vendor
  • Raising and responding to CAPA’s, GCP, and PII breaches
  • Feeding back issue resolution into revised training content
  • Escalation management within sponsor and vendor
  • Provision of dashboards and issue review meetings

For more information, please contact one of the Scimcon team today

+44 (1638) 661 631

info@scimcon.com

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