A collaborative workspace for aggregate safety report drafting
SafeDraft helps pharmacovigilance, safety, and regulatory teams coordinate sources, draft aggregate reports such as DSURs, and prepare controlled exports — with author and reviewer workflows that keep everyone aligned. Qualified human review and approval remain required at every stage.
Built for pharmaceutical and biotechnology safety, pharmacovigilance, and regulatory teams.
Illustrative interface. Final content requires qualified human review and approval.
Coordinate the work of aggregate safety reporting
SafeDraft brings the moving parts of aggregate report drafting into a single collaborative space so safety and regulatory teams can stay aligned throughout the cycle.
Aggregate report drafting
Draft aggregate safety reports in a structured, shared workspace, keeping section content, contributors, and versions organized in one place.
DSUR authoring
Author Development Safety Update Reports section by section, with a consistent structure that helps teams work through content methodically.
Source coordination
Track the sources and inputs that feed each section so contributors can see what is available, what is pending, and where content originates.
Reviewer & author workflows
Assign authors and reviewers, hand off sections, and follow a review flow that keeps responsibilities and status visible across the team.
Reporting calendars
Keep reporting periods, internal milestones, and data-lock dates in view so teams can plan the drafting cycle around key timelines.
Controlled export preparation
Prepare exports in a controlled way, assembling reviewed content for downstream handling by your team.
A guided drafting cycle, start to export
SafeDraft structures the drafting process into clear stages while keeping your team in control of every decision.
- 1
Step 1
Set up the report and calendar
Create the aggregate report workspace, define the reporting period, and add the milestones and data-lock dates your team plans around.
- 2
Step 2
Coordinate sources and assign work
Organize the sources feeding each section, then assign authors and reviewers so responsibilities are clear from the start.
- 3
Step 3
Draft and review collaboratively
Authors draft sections while reviewers provide feedback in a shared flow. Qualified human review and approval remain required before content advances.
- 4
Step 4
Prepare a controlled export
Once your team has reviewed and approved the content, assemble a controlled export for downstream handling by qualified staff.
Designed to support careful, accountable work
SafeDraft is built to help safety and regulatory teams work in an organized, access-controlled environment. The people using it stay responsible for the content they produce.
Important scope & limitations
- Qualified human review and approval remain required for all content produced or prepared with SafeDraft.
- SafeDraft is a drafting and coordination workspace. It is not described as validated software, and it is not represented as 21 CFR Part 11 compliant.
- Output from SafeDraft is not suitable as the sole basis for a regulatory submission. Your organization is responsible for final content, quality control, and submission decisions.
Access-controlled workspaces
Report content is organized in workspaces with role-based access, so contributors see the sections and materials relevant to their work.
Versioning and traceability
Drafts are versioned as they progress, helping teams see how content evolved and who contributed along the way.
Secure authentication
Client access is protected through authenticated sign-in, keeping report workspaces limited to authorized team members.
Human review by design
Workflows are built around author and reviewer roles so that qualified people evaluate and approve content before it advances.
See how SafeDraft fits your team
Tell us about your safety reporting needs and a member of the Report Pharm team will follow up to arrange a walkthrough of SafeDraft.
Already a client?
Existing users can access their workspace anytime via client sign in.
Prefer email?
Reach us directly at info@report-pharm.com.
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