DSURs
Development Safety Update Reports authored by ICH E2F-trained writers, fully aligned to the protocol's safety analyses and ISS pool.
Safety reporting regulators trust
DSURs, PSURs, PBRERs, integrated safety summaries, EU CTR annual safety reports, patient narratives — written by writers who sit next to the biostatisticians who own the data. One narrative bank across DSUR, ISS, and CSR; no rewriting, no inconsistency.
The safety-reporting portfolio.
One continuous team.
PSURs / PBRERs
Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports — including the integrated benefit-risk discussion expected post-EU CTR.
Patient safety narratives
Templated and bespoke narratives for SAEs, deaths, AEs of special interest, and treatment discontinuations.
Integrated safety summaries (ISS)
Pooled safety analyses across studies — exposure, AE incidence, lab abnormalities, deaths, narrative-driven serious events.
Annual reports
Investigator-initiated and sponsor-initiated annual safety reports including INDs and CTAs.
SAE / SUSAR coding & narratives
MedDRA / WHO-DD coding workflows, SAE narrative authoring, and reconciliation against the EDC.
EU CTR safety reporting
Safety reporting under EU CTR (Regulation 536/2014) — annual safety reports, expedited reporting, SUSAR exchange via CTIS.
Risk Management Plans (RMP)
EU RMP and FDA REMS sections — safety specification, pharmacovigilance plan, risk-minimisation activities.
Signal detection & evaluation
Quantitative and qualitative signal detection across pooled studies and post-market data.
Why this matters
A separate document chain — handled by the same team.
Post-EU CTR, regulators expect the benefit-risk story across PBRER, RMP, DSUR, and CSR to read as one coherent narrative. Fragment the writing across vendors and it doesn't. We keep safety reporting inside the same continuous biometrics team.
- One narrative bank across DSUR, ISS, and CSR
- Writers sitting beside the biostatisticians who own the data
- Authored to ICH E2, EMA / FDA, and EU CTR standards
- A single coherent benefit-risk story, not fragmented vendors
How we work
Set up → collect → analyse → write
A four-phase engagement integrated with your existing safety database and PV operations.
- 01
Set up
Plan the safety-reporting cadence with the sponsor: report types, frequency, pooling rules, MedDRA versions, narrative criteria.
- 02
Collect
EDC-integrated SAE / AE pull, central-lab safety data, narrative source documents — reconciled against the safety database.
- 03
Analyse
Statistical and qualitative analyses: exposure, AE incidence, AESIs, lab shifts, deaths — pooled across the indicated study population.
- 04
Write
Reports authored to ICH / EMA / FDA templates with biostat-integrated tables, narratives, and benefit-risk discussion.
At scale
Safety reporting at scale across our portfolio.
ICH E2F / E2C / E2D-aligned safety reporting
EU CTR safety-reporting expertise (Reg 536/2014)
MedDRA and WHO-DD coding to GCDMP standards
CTIS SUSAR exchange supported
24/7 safety helpdesk across timezones
800+ studies — safety reports across the portfolio
Frequently asked
Safety-reporting questions sponsors ask
Do you provide full pharmacovigilance services or only safety writing?
We focus on the writing and statistical-analysis side of pharmacovigilance — DSURs, PSURs, ISS, narratives. We integrate with the sponsor's PV operations (or a PV vendor's operations) for the case-management workflow itself.
Are your writers ICH E2F / E2C trained?
Yes — DSUR and PSUR authoring is routine. Our writers know the ICH templates, the EMA expectations, and how to integrate biostat-driven safety tables with narrative discussion.
Can you support EU CTR safety reporting?
Yes — annual safety reports, expedited reporting, and SUSAR exchange via CTIS. Our writers are current on the 2024 EU CTR safety-reporting best practice.
Do you handle MedDRA / WHO-DD coding?
Yes — coding to GCDMP standards with full audit trail. MedDRA coding sits within the CDM workflow and feeds directly into the safety reports.
How do safety narratives connect to the CSR?
Patient safety narratives written for DSURs and ISS work pool directly into the CSR narrative sections. One narrative bank, used across documents — no rewriting, no inconsistency.
What about Risk Management Plans?
EU RMP and FDA REMS sections are part of the service. The safety specification, pharmacovigilance plan, and risk-minimisation activities are co-authored with the sponsor's PV lead.
Related services
Medical writing
Where the safety writing sits inside the broader writing portfolio.
Explore →Biostatistical consulting
The biostatistics behind every pooled safety analysis.
Explore →Data management
Clean safety data starts in the EDC.
Explore →IDMC support
IDMC reporting for ongoing safety oversight.
Explore →