Due to recent drug safety cases, pharmaceutical, biotech and medical device companies are now faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires companies to take a more proactive approach to drug safety and pharmacovigilance. Companies simply cannot afford to overlook any vital safety information about their products.
Services
Our drug safety and pharmacovigilance team offers integrated services to help you develop and implement safety and surveillance programs for your products. We routinely collaborate with pharmaceutical and biotech companies, generic drug manufacturers and clinical research organizations (CROs) to provide:
Through these services, our experts can help you evaluate your product’s safety in clinical and post-marketing studies. We are committed to excellence and focus on real-world results and your satisfaction. Our experts have the necessary expertise and FDA and European regulatory know-how to help you effectively develop your safety management program and ensure regulatory compliance, so you can be confident your company is protecting its patients, study participants and reputation.
Deliverables
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Validated 21 CFR part 11 compliant safety database access and management
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SAE narratives
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Safety reports (domestic and international)
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Investigator brochures
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Electronic submissions
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Literature reviews and summaries
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Standard operating procedures (SOPs)
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Annual safety reports
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Study reports and protocols
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Periodic safety update reports
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Regulatory reports
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Informed consents
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Integrated summary of safety and/or efficacy (ISS/ISE) reports
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Benefit-risk assessments
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Pharmacovigilance training
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Signal detection
Related Services
Our drug safety and pharmacovigilance services are complemented by several of our other practice areas, including:
