Periodic Safety Update Reports (PSUR)
Full preparation and compilation of PSUR/PBRER documents covering all international birth dates, benefit–risk evaluations, and signal assessments aligned with ICH E2C(R2) guidelines.
Learn more →Clinical Overview compiles comprehensive effectiveness and safety data for medicinal products from Market Authorisation through renewal — delivering rigorous, independent reports that protect patients and uphold regulatory integrity.
Clinical Overview was established with a singular mission: to provide the pharmaceutical industry and regulatory bodies with rigorously independent, cumulated benefit–risk assessments that form the backbone of medicinal product safety.
Since a product's initial Market Authorisation or its most recent renewal, we gather, analyse, and synthesise all relevant effectiveness and adverse event data. Our reports are designed to satisfy EMA, FDA, and ICH requirements — but more importantly, they serve the patients who depend on these medicines every day.
From initial benefit–risk frameworks to full PSUR submissions, our expert team delivers the complete spectrum of pharmacovigilance reporting services.
Full preparation and compilation of PSUR/PBRER documents covering all international birth dates, benefit–risk evaluations, and signal assessments aligned with ICH E2C(R2) guidelines.
Learn more →Structured, independent benefit–risk evaluations drawing on cumulated clinical trial data, post-marketing surveillance, and spontaneous adverse drug reaction reports throughout the product lifecycle.
Learn more →Systematic monitoring of all data sources for emerging safety signals, including disproportionality analysis of spontaneous reports from EudraVigilance, FAERS, and VigiBase.
Learn more →Ongoing systematic searches of peer-reviewed medical literature and grey literature sources to identify all relevant safety and effectiveness information for inclusion in cumulative data.
Learn more →Development and maintenance of EU Risk Management Plans (EU-RMPs) and Risk Evaluation and Mitigation Strategies (REMS) to proactively characterise and minimise known product risks.
Learn more →Expert strategic counsel for pharmacovigilance audit preparation, responses to regulatory agency queries, PRAC assessment reviews, and post-authorisation safety study design and oversight.
Learn more →Our reports don't just satisfy regulators — they actively protect the patients who depend on the medicines we scrutinise.
The PSUR Clinical Overview produced for our oncology portfolio was exceptional — the benefit–risk argumentation was so robust that the PRAC assessors had no queries at all. First submission, zero come-backs. Remarkable.
We switched to Clinical Overview after two difficult PSUR cycles with another vendor. The difference was immediate: thorough literature searches, meticulous signal tracking, and a team that genuinely understands the science behind the safety data.
As a small biotech with limited internal pharmacovigilance capacity, Clinical Overview has been indispensable. They scaled with us through IND to NDA, always keeping our safety profile clearly articulated to regulators. I can't recommend them highly enough.
Whether you need a PSUR for an upcoming IBD, a full RMP, or regulatory strategy advice — our senior team is ready to assess your needs within 48 hours.
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