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… Benefit-Risk Assessment Do your product’s benefits outweigh its potential … for possible new studies to include in your clinical development program and clarify appropriate post-approval …
… Benefit-Risk Preferences Benefit-risk preference studies are a specific application of … risk management strategies throughout the product development, regulatory, and post-marketing lifecycle. …
… Market Research We can collaborate with you to develop and support marketing strategies for your pharmaceutical products and/or devices. Our market research services include: Qualitative research (interviews … results (e.g., scientific conferences, peer-reviewed publications ) …
… Utility Assessment Health utility estimates provide a representation … to incorporate the perceived value of a given health benefit into decisions regarding allocation of health care … such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team …
… Collaborative Regulatory RWE Research Through our Barcelona based team, we are a partner … Medicines Agency. We are dedicated to excellence in research by adhering to the ENCePP Guide on Methodological … Alejandro Arana is the Co-Chair of the Working Group on Research Standards. We are also a charter member of the …
… address a safety issue of regulatory importance within a risk management plan Designing studies to evaluate the … plans to use in regulatory discussions Advising on benefit-risk assessment methods for specific products Selecting analytic …
… Database and Registry Research Within pharmacoepidemiology research, secondary … Our experts have conducted database studies for pharmaceutical clients at the request of the US FDA, EMA, and … of Health Sciences (IACS)* Information System for the Development of Research in Primary Care (SIDIAP)* Valencia …
… Instrument Development In accordance with regulatory guidelines and … questions, and response scales Translatability assessment and cross-cultural adaptation Migration to … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… In addition, our statisticians are well versed in outcomes research methods and will work with you to plan and analyze … can help patients evaluate the trade-off between clinical benefit and treatment toxicity to make informed treatment … the Q-TWiST method to quantitatively assess the benefit/risk tradeoff of your new treatment regimen. Healthcare …
… Regulatory Real-World Evidence Research Let us help you ensure the safety of your patients … indicators and using real-world evidence to support your development and post-approval activities. To understand disease distribution, risk factors, treatment patterns and impact, comorbidities, …