Good pharmacovigilance practices start with a good plan. We provide a bottoms-up approach to managing your pre- and post-marketed product safety program that will save you time and money and allow you to make good commercialization decisions about your products. These services include:
SAE/AE Handling
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Call center support
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Adverse event (AE) and serious adverse event (SAE) data entry and logging
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Current treatment utilization patterns
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Disease burden and prevalence
Data Management
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AE and SAE logging, tracking, coding
and case processing
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MedDRA and WHO-DD coding
Medical Analysis
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AE and SAE evaluations
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SAE narrative writing
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Physician medical review and signal detection
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Literature reviews and summaries
Regulatory Reporting
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Generation of MedWatch 3500A/CIOMS I forms
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Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
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Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports
Electronic Adverse Event Reporting
We understand that accurate reporting is vital to your safety programs. European regulators now require electronic submissions of individual case safety reports (ICSRs); and although currently voluntary in the US, it is anticipated that the FDA may require electronic reporting of SAE/AEs in the near future. This is why we have selected a leading safety database application to record and report SAE/AEs on behalf of our clients. It is a fully validated 21 CFR Part 11 compliant database that supports multiple products and studies. Furthermore, routine back-up and disaster recovery systems and procedures are in place, which is essential for safeguarding your data.
End-User Focused Approach
We follow the FDA's Good Pharmacovigilance Practices and EMEA's European Directive 2001/20/EC guidelines and focus our work-products on the end-user perspective, so practitioners and patients can fully realize the risk and benefits associated with a particular remedy. You can expect to work with a team of professionals who deliver quality results on-time and within budget.
