Medical Writing Software
Accelerate Medical Writing Without Compromising Accuracy or Compliance
In the fast-paced world of clinical research, the ability to produce, review, and finalize high-quality documents—on time and with full regulatory compliance—is non-negotiable. Ideagen Document Review (formerly known as PleaseReview) is the trusted collaboration and co-authoring platform that enables clinical teams to streamline document reviews, reduce version chaos, and ensure traceable, auditable feedback across the board.
Why Clinical Teams Trust Ideagen Document Review
- Real-Time Collaboration Without Losing Control
- Ideagen Document Review allows multiple reviewers—regulatory, medical, legal, and clinical—to co-author and comment on a single live document. No more version proliferation, conflicting edits, or lost comments.
- Regulatory-Grade Compliance
- Built with 21 CFR Part 11 and GxP compliance in mind, every review is fully auditable. Ideagen Document Review captures every change, comment, and action, giving you a clean regulatory trail that supports both FDA and EMA submissions.
- Transparency From Draft to Submission
- With customizable reporting and dashboard views, you can monitor document status, unresolved comments, stakeholder activity, and timelines—all in one place.
- Designed for Medical Writing Teams
- Support for Word, PDF, and structured content (e.g., protocol templates, CSR sections) makes it ideal for managing large, complex clinical documents. Built-in tools help ensure scientific accuracy and editorial consistency across contributors.
- Integrates With Your Tech Stack
- Whether you use Veeva Vault, Generis CARA, Documentum D2, InteliNotion or other clinical document management systems, Ideagen Document Review can seamlessly integrate to ensure the document stays protected and controlled at all times.
Discover integrations Ideagen Document Review Integrations & Partners
- Simplify redaction for EMA Policy 0070 compliance
- The redaction categorization function is used to customize the appearance of redactions (e.g., color, font, and overlaying text) when downloading redacted PDF documents. It’s preconfigured for the following comment categories: ‘EU70-PPD’ and ‘EU70-CCI’.
Use Case: Simplifying the Clinical Study Report (CSR) Process
Challenge: A global CRO needed to align over 15 reviewers across clinical, statistical, regulatory, and quality functions on a single CSR draft under tight deadlines.
Solution: Ideagen Document Review enabled simultaneous, trackable input across functions—cutting document review cycles by 40% and avoiding compliance risks related to uncontrolled versioning.
Result: Final CSR approved and submitted 3 weeks ahead of schedule.
Who Benefits From Ideagen Document Review?
- Medical Writers & Editors: Maintain control over document structure, style, and timelines.
- Clinical Operations: Ensure efficient stakeholder engagement and on-time delivery.
- Regulatory Affairs: Demonstrate compliance with full audit trails and locked final versions.
- Sponsors & CROs: Collaborate transparently across internal and external teams.
Trusted by Life Sciences Leaders Worldwide
Join over 250 life sciences organizations that rely on Ideagen Document Review to manage critical documentation across clinical trials, submissions, and post-marketing activities.
“Everyone involved in drug development knows that, today, acceleration of timelines is the name of the game. That is what this is really all about: getting the drugs to market that are going to help the people who need them. Ideagen [Document Review] is an important player in this arena.”
— Diahann Homer (PhD), Medical Writing Expert. Diahann has previously established and led medical writing groups at GSK Oncology, Nestle/Galderma, and Taiho/Otsuka.
Explore customer stories Customer success stories for Ideagen Document Review
“The Ideagen Document Review system allows users to classify each comment or edit in the system with pre-existing and customized categories. The key to the categories is that I want to be able to sort comments and edits effectively and start updating the document while the review is ongoing. Customized categories improve handling of the teams’ comments and edits.”
Laura Oberthur-Johnson (PhD), Medical Writing Expert, who formerly led medical writing teams at PPD, a global CRO.
Discover Laura’s step-by-step guide to controlling risks in medical writing reviews. Packed with tips on how to spot risks early, cut the comment chaos, and stick to timelines. Get the guide Controlling risks in medical writing reviews guide
Get an interactive demo Ideagen Document Review demo
See how Ideagen Document Review can streamline your medical writing process while meeting the highest standards in regulatory compliance.
Ideagen Document Review is your partner in getting clinical content right—faster, smarter, and always audit-ready.