Aggregate Reports & Scientific Writing
Clear Data. Precise Writing. Compliant Reporting.
Aggregate safety reports are essential pharmacovigilance documents required by global regulatory authorities to continuously evaluate the benefit-risk profile of medicinal products. These reports integrate safety data from multiple sources, including individual case safety reports (ICSRs), clinical trials, literature, and signal detection activities.
SCIOM supports the preparation, medical writing, and submission of aggregate reports and pharmacovigilance documentation. Our medical writers and safety physicians ensure that safety data is accurately analyzed and presented with scientific and regulatory precision, meeting global reporting requirements.
Consistent, high-quality aggregate reporting and timely submissions support regulatory compliance and help maintain ongoing marketing authorization across global markets.
Talk to PV Expert
Our Reporting Performance
Accuracy You Can Trust. Timelines You Can Rely On.
0
On-Time Regulatory Submissions
0
Aggregate Safety Reports Prepared
Global
Regulatory Compliance (EMA, MHRA, FDA & Health Canada)
Multi-Tier
Quality Review for Scientific Accuracy
Aggregate Safety Reporting Capabilities
Turning Safety Data into Meaningful Insights
Our capabilities cover the preparation of key aggregate safety reports and pharmacovigilance documents required to support regulatory compliance and ongoing benefit-risk evaluation.
-
Periodic Safety Update Reports (PSUR) / Periodic Benefit Risk Assessment Report (PBRER)
-
Periodic Adverse Drug Experience Reports (PADER / ASR)
-
Development Safety Update Reports (DSUR) for IMPs
-
Annual Safety Reports for Canada and other applicable markets
-
Risk Management Plan (RMP) development and updates
-
Pharmacovigilance System Master File (PSMF) authoring
-
Clinical trial safety documentation
Our Reporting Process
Structured Steps. Accurate Outcomes.
Strategy & Kick-off: Aligning on templates, data sources, and defining the safety narrative.
Data Extraction & Line Listings: Pulling validated data from the safety database and literature reviews.
Medical Writing & Analysis: Drafting the core document, integrating signal data and benefit-risk evaluations.
Medical Review & QC: 100% independent Quality Control check and senior PV Physician review.
QPPV Oversight & Final Approval: Final review by the QPPV to ensure regulatory compliance and accurate representation of the product’s benefit–risk profile prior to submission
Why Choose Sciom for Aggregate Reporting & Scientific Writing
Expert Writing. Reliable Reporting
Experienced medical writers and safety physicians
Expertise in global PV regulations
Structured review process ensuring accuracy and regulatory compliance
Inspection-ready documentation aligned with GVP and local requirements
Proven track record of consistent on-time regulatory submissions
Insights & Industry Trends
Stay informed with expert commentary on pharmacovigilance services, regulatory consulting services, analytical science and audit compliance services across the pharmaceutical industry.
