Medical writing hacks: managing feedback in document reviews
A swift and efficient document review process is increasingly vital to helping medical companies get their drugs approved and into the hands of the people that need them as quickly as possible. However, the medical writing review process continues to be held back by administrative challenges and technical issues.
One of the most significant issues facing medical firms is people management, including obtaining contributor and reviewer feedback efficiently and on time. Common platforms used for document collaboration, such as SharePoint, make it challenging for document owners to manage multiple reviewers and ensure collaborators keep to project timelines. This typically results in deadlines being missed or feedback from necessary functions being lost or overlooked.
Some review platforms also make it difficult for document owners to keep track of contributors’ comments and edits. While others crash when multiple people try to modify or comment on a document simultaneously.
How Ideagen PleaseReview enhances document collaboration
Ideagen PleaseReview is a solution for document review and co-authoring processes, which enables companies to deliver high-quality documents in shorter timeframes. The solution helps people to collaborate seamlessly on writing, reviewing, and reconciling records. It also makes it easy to collaborate securely with both internal and external contributors with a full audit trail.
PleaseReview addresses the challenges that businesses face with multiple reviewers collaborating on documents. It does this through automatic activity tracking, which makes amendments visible to all reviewers in real-time.
The platform allows hundreds of reviewers to view and modify a document simultaneously, a volume of traffic that would cause other document review tools to crash or delete comments. As a web-based solution, ithe solution also simplifies the process of onboarding external collaborators by ensuring they can work on relevant sections of a document without gaining access to sensitive internal systems and data.
PleaseReview also prioritises simplifying life for document owners. It gives a document owner total control and visibility of what’s happening in a document review, ensures they can track the reconciliation of amendments, and enables them to colour code and categorise items to make the review process more efficient.
Document owners and writers can review collaborators' comments, and individual team members can be tagged and notified to address any specific requests. That helps to drive engagement among teams and reduces the administrative burden from document owners, who would previously have to spend time chasing people for feedback or amendments.
Furthermore, the solution enables document owners to showcase to reviewers that their edits have been considered and were crucial to the process. As a result, the program can help document owners thank reviewers for the time spent providing insight and prove their comments have been considered.
How uniQure mastered document writing with PleaseReview
uniQure, a global leader in gene therapy based in the Netherlands, relies on an efficient medical writing review process to get transformational gene therapies to patients as quickly as possible. However, its previous tool struggled to provide the control and functionalities it required, which resulted in the editing process taking too long. uniQure’s challenges included:
- Version control: uniQure previously had no clearly defined location for documents that were in progress or had been finalised. This meant the company struggled with document deduplication issues, employees struggled to locate the final versions, and caused issues with audit trails across old documents.
- Administrative struggles: uniQure’s previous system would struggle when multiple people attempted to access or edit a document simultaneously. Document owners would also spend vast amounts of time chasing collaborators and reviewers by email, text message, and phone calls. They also wasted time consolidating feedback from multiple copies of the same document.
- Activity tracking: Document owners struggled to gain visibility of collaborators who had accessed the review process. They also found it difficult to access then rectify edits and questions posed by reviewers.
- Unfocused reviewers: Document reviewers would often edit sections outside their remit or make micro edits throughout the document rather than focusing on areas specific to their expertise. This slowed down the process, required additional revisions, or forced document owners to amend unnecessary changes.
- Unresolved amendments: Medical writers would pose questions to specific reviewers, but these were frequently overlooked, which placed an even greater burden on document owners.
To address these issues, uniQure needed to redefine its process for authoring, reviewing, and approving medical documents. It required a process that ensured document development was consistent and structured, from the time of content approval through to final submission.
uniQure turned to Ideagen PleaseReview, which quickly addressed several issues the company was struggling with, for example:
- Hundreds of collaborators: uniQure now has a stable and secure environment for document reviews. The company has proven PleaseReview can easily handle more than 400 collaborators accessing, editing, and commenting on articles simultaneously. This has eradicated any concerns about systems crashing, lost work, or duplicated documents.
- Seamless review: PleaseReview removed concerns about duplication by providing simultaneous review and version control capabilities. This enables uniQure to rest assured that all changes are recorded in real-time, which means no edits can be lost or overwritten. PleaseReview also provides an automatic reconciliation report, which captures all review activity for auditing and compliance purposes.
- Secure data: In addition to offering simultaneous collaboration, uniQure can ensure external collaborators can’t access its internal files and systems. Its sensitive data is always secure, and the company can comply with increasingly stringent regulatory and industry standards around data privacy and governance.
- Comprehensive feedback: Document owners can easily accept or reject edits and changes within a single version. That means people don’t waste time consolidating feedback from multiple document versions and ensures no edits are missed or overlooked. The solution also schedules reminders to reviewers, which eases the burden on document owners having to chase individual collaborators.
- Focused reviews: Reviewers’ specific focus areas are locked into sections within the document. This ensures that collaborators can only provide feedback on areas where their expertise is required, preventing them from moving out of their lanes or providing unnecessary micro edits. Reviewers are also held accountable as PleaseReview makes it easy for document owners to see who’s accessed the articles, contributed feedback, and completed their review.
- Simplified reviewing: PleaseReview has helped uniQure to easily add or remove reviewers from projects, which is crucial as collaborators’ availability or responsibility changes.
As a result of deploying PleaseReview, uniQure has enjoyed cost savings of 35% compared to trying to manage its document review process manually. The company has also experienced significant administrative benefits, with the solution offering time savings of up to 65% for every document review.
uniQure has also identified three key areas where PleaseReview has enhanced its medical writing processes:
- Enhanced focus: Document owners can guide reviewers to where their input is most required in real-time. By locking reviewers to sections requiring their input, collaborators don’t spend time revising information that’s already been agreed upon and focus solely on the critical issues.
- Document quality: PleaseReview offers uniQure more time to focus on the quality of its content and removes the reliance on manual, error-prone, and labour-intensive tasks.
- Increased transparency: PleaseReview provides a reconciliation report that automates the documentation of all review activity. This eliminates the need for the company to manually document information like review participation and edits, comments, and resolutions on documents. The report also explains why comments or corrections were accepted or rejected, which is crucial to providing clear audit trails and appeasing reviewer concerns.
Take Control Of Medical Writing And Reviews
Ideagen PleaseReview helps medical organisations write and review documents more effectively. The technology guarantees medical companies produce higher-quality documents in a shorter timescale, which is crucial to them speeding up their drug development processes and getting medication into the hands of patients that need it as quickly as possible.
As a result, PleaseReview helps medical companies achieve significant time and cost savings. This is vital as organisations seek to improve their working methods to comply with increasingly stringent industry regulations and standards.
PleaseReview has been widely adopted by highly-regulated sectors like Energy, Government, Life Sciences, Military, and Utilities. It’s also relied on by 85% of the top 25 global pharmaceutical firms and 80% of leading CROs, medical device firms, and defence contractors.
Discover how PleaseReview can transform your company’s medical document review process.
uniQure's success story
Find out more about how the technology helped uniQure by reading the case study.
Read case study