Soterius can support sponsors in signaling activities
for the molecules under clinical investigation.
In carrying out this work, our team will review
publications identified from targeted literature
surveillance and perform a thorough review of
historical and current period listing of serious and
non-serious adverse events, going in-depth into
events and cases of interest to assist sponsors to
determine the relevance of any potential signals.
Soterius will actively participate in signaling and
trend analysis meetings.
The signal detection and analysis team at Soterius is
highly experienced in pharmacovigilance processes
and is well-versed in Global Pharmacovigilance
Regulations, including EU-GVP Modules, USFDA
guidelines, and ICH guidance. They specialize in
safety signal detection for various molecules in
Phase 1a/1b and Phase 2 of development. Some of the
clinical phase molecules they have experience with
include an anti-parasitic drug for a non-infective
indication, a ROCK2 inhibitor, an anti-PD-L1/IL-15
fusion protein for oncology and cGVHD/autoimmune
conditions, a PERK inhibitor, a GCN-2 Inhibitor, and
an immunomodulator for oncology.
The Soterius team assesses various safety sources
for signal detection, including Clinical Databases,
Pharmacovigilance Safety Databases (SAE),
Published Literature, Risk Management Plans
(RMPs/REMS), Aggregate Reports (e.g., DSURs),
Regulatory Requests, Regulatory Websites, FAERS/
other Regulatory Databases, Existing Signals, and
Events to Monitor/Report. They use specific criteria
to identify potential signals that need validation
and further evaluation from Clinical and Safety
Databases.
Any serious event cumulatively with causality assessed as possible or higher, OR
Any event with at least possible or higher causality, mentioned in the Designated Medical Event (DME) list (European Medicine Agency) OR
Any event mentioned in any Client-specific event monitoring list (AESI), OR
Any event mentioned in Dose-Limiting Toxicity (DLT), OR
Non-serious events: a high level of scrutiny of individual events in early phase trials with small numbers of subjects should be considered. Factors to consider include: adverse event grading (increased scrutiny for higher severity events), specific adverse events, increased incidence threshold (comparing the rate or proportion of the AE in the treatment group vs. control group or baseline), increased frequency in the study participants.
The team meticulously examines historical and current listings of serious and non-serious adverse events, going in-depth into events and cases of interest. This helps sponsors assess their significance of potential signals.
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