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Clinical data transparency and public disclosure

Global disclosure compliance can be incredibly daunting. Clinical trial data, registering clinical trials and reporting trial results need to be thought of in terms of data management. A greater focus has been placed on posting results of clinical trials for public disclosure.

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Evidence-based decision making

An essential element of clinical research is data transparency. It qualifies evidence-based decision-making within the life science industry and crucially, aids in legal obligations and compliance considerations. Clinical trial disclosures can be managed with SaaS software and there are many features that PleaseReview has that supports transparency and disclosure.

Our success stories showcase how some of the market leaders in life sciences have benefitted from using PleaseReview.

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Collaborative authoring

Authors, reviewers and approvers can work on a document in real-time, across departments and locations.

Evolving guidelines

Eliminate the need to stay on top of regulatory, auto-assessing and disclosure requirements.

Correct formatting

Submissions can always be formatted to the requirements of the trial registries by uploading and storing templates.

Access and permissions

PleaseReview allows you to restrict access to specific parts of the document, right down to individual sections.

Version control

Keep the comments and edits in one place to eliminate multiple versions, with the ability to compare updates side by side.

End-to-end management

PleaseReview can manage all documents through the disclosure process.

Scalability

Make room to accommodate your organization’s growth with no limit to the number of documents you can add and review at a time.

Audit and reporting

Easily generate reports to evidence compliance and share with auditors, executives, and stakeholders.

Faster, better quality documentation

To drive exceptional business value, your focus should be on quality and risk management across the entire value chain, from sourcing and manufacturing to supply-chain, improving both revenue and bottom line significantly.

PleaseReview is used widely by medical writing, regulatory, clinical, quality, and other professionals within the life sciences sector. As documents become more complex, more people need to be involved in their creation and review. Collaborators and reviewers can seamlessly view, comment, edit, and approve reports, submissions, and publications all in one place without the worry of missing any contributions. PleaseReview helps you to control and manage all aspects of document collaboration.

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Work more effectively with teams and stakeholders.
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Have better control of the document – keeping all updates and comments within a single version.
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Cut the risk of document error.
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Keep a full audit by automatically creating a complete report of all activity on the review.

Improve the quality of your document production

While medical writers are experts in writing and editing, they often struggle to collaborate efficiently on complex documents due to the number of editors involved in a single review.

Establishing best practises across your team and contributors sets the tone and trajectory for success from the beginning. Ideagen collaborated with Kim Norris, Director of Medical Writing at UniQure to establish the top five tips and tricks every medical writer should know.

 

Learn how you too can join four of the top five CROs in producing the highest quality documentation

Download handbook

Medical writing: innovation, trends and best practices

If you’re a medical writer or a medical editor, you have a crucial role to play in ensuring the accuracy, clarity, and consistency of your organization’s manuscripts, as well as their compliance with key industry standards and guidelines.

When you’ve spent months crafting an intricate medical writing document with your team, with many people going back and forth viewing, reviewing, and re-reviewing again and again, there can often be small typos and inconsistencies that still jump out at your reader. They weaken your credibility.

Read our 5 top editing tips for medical writers.

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Follow best practices and manage clinical data appropriately with PleaseReview

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Additional Resources

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Lexicon

Ideagen’s PleaseReview helps Lexicon Pharmaceuticals save hundreds of hours by reducing document review times

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Translate Bio

Translate Bio use PleaseReview to collaborate seamlessly with regulatory authorities around the world

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PleaseReview success stories

In response to the COVID-19 crisis, the top 5 approved vaccines were developed in record time with the help of PleaseReview, our real-time document collaboration tool.

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