CDS offers complete pharmacovigilance services in Canada and the US . . .during clinical trials and post-market approval.

Our extensive knowledge of regulations on adverse events in the United States, Canada and Europe enables us to plan and implement your adverse event management for clinical trial and marketed products. Our Safety Team are supported by a validated Clinical Safety Database based on the E2B and MedDRA industry data standards.

CDS END-TO-END PHARMACOVIGILANCE SERVICES INCLUDE:

• validated safety data-base design

• post-marketing documentation

• post-approval study activities

• management and follow-up of spontaneous, literature and solicited Adverse Event (AE) reports

• AE/ADR coding per the Medical Dictionary for Regulatory Activities (MeDRA)

• preparation of periodic reports: PADER, PBRER, PAER, PSUR

• ongoing signal detection analysis

• preparation and submission of a Risk Evaluation and Mitigation Strategy (REMS) if required

• labeling activities: input on creation and maintenance of Product Inserts (PIs)

• study regulatory document input including Investigator’s Brochure (IB) or Reference Safety Information (RSI)

• training of all personnel involved in pharmacovigilance activities including home office and field force staff