Innovative Operational Approach to Safety

Our team effectively manages SAEs in a time-sensitive and regulatory-compliant manner. Drug Safety services for Phase I-III development include: SAE reporting. SAE processing. Narrative writing. Medical review . Lab and diagnostics test review. Safety report distribution and submission. Expertise in all major systems (ARISg, Oracle AERS). On-site training in pharmacovigilance and risk management.
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Pharmacovigilance and Peri-approval

We reinforce our peri-approval services with periodic aggregate reports, trending analysis and ad hoc safety signal analyses, in addition to the review of solicited and spontaneously reported adverse drug reaction case data. We also serve as the safety department for companies lacking their own in-house resources and confidently manage the transition of medicines in clinical development to marketed products.

Pharmacovigilance Support

Safety services for marketed products include:

Post-marketing surveillance. SADR, spontaneous ADR processing and reporting.

Serious adverse event (SAE) processing and reporting

Lab and diagnostic test review

Periodic safety update reports (PSUR), annual and quarterly report preparation

Signal detection services

Trending analyses for labeling changes

Argus safety database

REMS/RMP design and advisory consultation.