Periodic safety reporting, always on schedule
Schedule every periodic report automatically, track each data lock point and due date, and detect emerging safety signals with proven statistical methods. It all runs through a governed, auditable lifecycle.
Every periodic report, planned and written in one place
Set it up once, and every PADER is scheduled for you
Configure each product and report type a single time. The system builds the full schedule, works out every data lock point and due date, and moves to annual reporting at the right point on its own.
- Automatic schedule. Quarterly PADERs move to annual after 12 quarters, with schedules generated up to 50 years ahead.
- Choice of anchor date. Start from the approval date, the transfer date or a date you enter, reusing your product master.
- Calculated due dates. DLP at period end, internal due at DLP + 20 or 40 days, and authority due at DLP + 30 or 60 days.
- Review workflow. Planned, Drafting, Quality review, Medical review, Client review, Submitted. Moving a report back needs Aggregator approval.
- Automatic overdue. A daily job flags any report past its authority due date and sends the alerts.
- E-signed calendar versions. Each "Approve & Generate" creates a signed calendar version, kept separately for PADER and PSUR.
- Project-level rules. Set once for a project and pushed to all its products. A changed product record sends its setup back for review.
DLP 31 Mar · due 30 AprAcknowledged
DLP 30 Jun · due 30 JulSubmitted
DLP 30 Sep · internal 20 Oct · due 30 OctMedical review
After 12 quartersPlanned
Author PSURs, PBRERs and DSURs in one place
Start from a ready-made template, enter the report profile once and let product, project and case data fill in each section. Optional AI drafting gives your medical writers a first draft, and their edits always win.
- Templates. PSUR (13 sections), PBRER (20 sections per ICH E2C(R2)) and DSUR (per ICH E2F).
- Enter it once. The report profile feeds every section, and product, project and case data fill in automatically.
- Optional AI drafting. Each section asks for the fields it needs and can draft text with an LLM. Manual writing works without it.
- Rich-text editor. Every section shows whether it is empty, generated or edited.
- Versioned exports. Whole-document preview, then DOCX and PDF exports, each kept as a new version.
- Bound e-signature. The Part 11 signature is stored with the document so the two can't be separated. Draft → generated → finalized → signed.
- Cycle management. Half-yearly PSURs move to annual after four cycles, after which the MAH sets the cadence.
Product B · PBRER · DLP 30 SepComplete
Drafted from product dataGenerated
Author changes appliedEdited
Awaiting author inputEmpty
DOCX + PDF · e-signedSigned
See every due date, for every product
One calendar shows every PADER, PSUR, PBRER and DSUR across your portfolio, so nothing slips between teams.
- Month, quarter and year views. Colour-coded by status and filtered by product, report type and status.
- Upcoming windows. See what is due in the next 30 and 60 days at a glance.
- E-signed calendar versions. Each "Approve & Generate" creates a signed version, kept separately for PADER and PSUR.
- Bulk assignment. Assign authors and reviewers to many reports at once.
- Register export. Export the report register, and correct a period manually when a product changes.
4 reports due · 1 overdueReview
Authority due 30 OctOn track
Medical reviewIn review
Approved & generatedSigned
Compliance you can see coming
Tiered alerts
The safety team is alerted 10 days before completion and regulatory 7 days before the authority date. Overdue items escalate automatically every day.
Every channel
In-app notifications, email with open tracking and one-click acknowledgement, and dashboard badges.
Executive compliance view
On-time percentage, overdue count and upcoming 30- and 60-day deadlines at a glance.
Tracker analytics
Breakdowns by product, report type and status, with monthly compliance trends.
Team workload
Bulk assignment of authors and reviewers, with each report's owner visible on the calendar.
Part 11 signatures
Re-authentication to approve schedules and sign report exports, with the signature stored in the document.
Aligned with
AI drafting for periodic reports
Each PSUR, PBRER or DSUR section can be drafted by a language model from your product, project and case data, and the author’s edits always win.
Section drafting
Optional AI drafting for each section, and manual writing works without it.
Filled from your data
The report profile, product and case data fill in each section automatically.
Author stays in control
Every section shows whether it is empty, generated or edited.
Signed output
DOCX and PDF versions, with the Part 11 signature stored in the document.
Explore the connected suite
Take the scramble out of aggregate reporting
See your PADER, PSUR and DSUR calendar generated in minutes, with sections drafted from your own data.