uniQure gets transformational gene therapies to patients quicker
Kim Norris has been director of Medical Writing at uniQure, a Netherlands and US-based gene therapy company, since 2021.
• Has used Ideagen PleaseReview for more than 10 years
• Previously held senior roles in Synta Pharmaceuticals; LFB USA; Synchrogenix; Aeglea BioTherapeutics; Genzyme and Ilex Oncology.
• Key therapeutic area experiences: oncology and neurology.
PleaseReview gives you a perfect audit trail. I have made its acquisition a requirement at every organisation for which I’ve led Medical Writing.
Kim’s main challenges before Ideagen PleaseReview
• Define and refine processes for document authoring, review, and approval. Kim needed to create a structured and consistent process for document development, from concept to approval and submission. This effort included development/revision of SOPs and Work Instructions, as well as creating a company Style Guide and conventions.
• Version control. There was no clearly defined location for either files in progress or final versions; this was an issue in terms of locating actual final documents and checking audit trails for former documents.
• Administrative burden. A great deal of time was being spent chasing people via email, text messages, and phone calls, as well as consolidating feedback from multiple copies of the document.
• Difficult to trace activity. Document owners could not see who had already begun and who had not, nor could they see the edits and questions other reviewers had posed.
• Reviewers not focused. Reviewers often edited sections that were outside their area of expertise—or they made microedits throughout the document rather than focusing on the questions for their subject matter area.
• Outstanding issues. The medical writers would include specific questions for specific reviewers within the
document and, as a result of lack of focus, these questions and issues were frequently initially overlooked.
uniQure’s top 10 challenges and solutions
Challenge
How Ideagen PleaseReview solved it
Duplication of work
Simultaneous review and secure version control means no more duplicate work
Tracking accepted changes
All changes recorded; nothing is lost or overwritten
Platform limitations when more than 3 colleagues work in real-time
A stable environment for a high volume of users to work simultaneously
Tracing of document activity for audits
Automatic reconciliation report captures all review activity. CFR Part 11 compliant
Time spent on consolidating feedback from multiple versions
Easily accept or reject changes within a single version of a document in a transparent manner
Manually chasing colleagues across platforms
Scheduled reminders sent from Ideagen PleaseReview at pre-specified intervals
Disputes on decisions made within the document
Reconciliation report makes it easy to show who made what change when, where, and why, as well as what the disposition was of those changes
Reviewers don’t stay in their lanes
The ability to lock-in sections of text for editing ensures that reviewers are better able to focus on the sections where their input is most important
Difficult to make reviewers accountable
Review details page makes it easy to see who has and hasn’t begun, how much they have contributed, and when they have completed their review
Changes to list of review participants
Easy to add and remove reviewers from the project as reviewer availability or responsibility changes
PleaseReview allows us to achieve significant time savings for all involved. More important than the time saving, though, is the focus and the quality of the review, as well as the transparency of the process.
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Proven to provide cost savings of 35% compared with manual processes
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Proven to provide time savings of up to 65% per document review
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Proven to accommodate teams of 400+ users without crashing
Top three benefits of Ideagen PleaseReview for uniQure:
Focus
“You can guide the reviewers in real-time to the location where their input is critical. The ability to lock-in sections for editing means that reviewers don’t spend time revising sections that have already been agreed to and they focus on the critical issues.”
Quality
PleaseReview “gives us more time to focus on the content and quality of the review. It takes away manual, labor-intensive tasks by doing them for us.”
Transparency
“The reconciliation report provides automated documentation of all review activities, thus eliminating the need for manual documentation of things like review participation and changes, comments, and resolutions. This transparency is important because someone inevitably asks why a change was or was not made. With the report, you’re able to locate the reason you provided at the time. In this way, PleaseReview gives you a perfect audit trail.”
Key features
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Collaborate on the same documents simultaneously
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Keep sensitive data secure
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Comply with regulatory and industry standards
What would Kim say to organizations that are considering Ideagen PleaseReview?
“PleaseReview is a bit like chess. It’s easy to learn at the beginning, but you can really go far in customizing it. The versatility of the software allows for the implementation of PleaseReview at a basic level with the potential to use it at a highly sophisticated level, depending on the organization’s needs.
Since being introduced to this software years ago, I have made its acquisition a requirement at every organisation for which I’ve led Medical Writing.
When looking for a new role, one of the factors I consider during the interview process is if the organization already has PleaseReview or if they are willing to obtain it. When interviewing candidates, one of the questions I always ask is if they have familiarity with PleaseReview.”
The roll-out at uniQure was simple, straightforward and people caught on very quickly.
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