Evidence based analysis, decision making and action- Building on a careful appraisal of available evidence we provide guidance for characterizing, assessing and mitigating patient safety and benefit risk issues.
Client-oriented, practical solutions from first in man to post-approval management of safety and effectiveness.
Client focused, practical solutions- Committed to our clients, we strive to develop relationships based on trust and transparency. We offer efficient solutions to current and anticipated needs.
Integrity and regulatory compliance- We share with our clients appreciation of the responsibilities and public trust implicit in developing and commercializing medical products. By monitoring evolving environments we ensure that our recommendations are aligned with client regulatory and commercial strategies.
Global outlook- All our analyses and recommendations are embedded in the understanding that development, production, regulation and commercialization of medical products are part of a complex global web. Our risk management strategies take into account regional differences while leveraging similarities and identifying synergies.
Life-cycle perspective- Benefit risk issues emerge and evolve throughout the course of the product life cycle. We assess both non-clinical findings and clinical experience to help clients with critical decisions for development strategy and commercialization.