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… Evidence Assessment for a Digital Medical Technology OPPORTUNITY Our client’s digital … by the National Institute for Health and Care Excellence (NICE) in the United Kingdom and was not recommended for use … NICE guidance on medical devices, diagnostics, and digital technologies. Our team reviewed clinical data on the …
… Regulatory Guidance and Support We can support you throughout your … to the FDA following the release of the FDA’s PRO Guidance. To support these efforts, we have developed more …
… Medical Technologies Chart a complete course to commercial success. … the value of their medical devices and tests. We provide guidance on health economic and outcomes measures that will … research Q-TWiST Preparation of HTA submissions (i.e. NICE) Reimbursement and value communication strategies …
… Early Dialog with NICE and EUnetHTA See the research: Early dialogue with NICE and EUnetHTA: a UK perspective in a politically uncertain ERA Heyes A, Millar …
… submissions (meeting the requirements of agencies such as NICE, SMC, CDR, and PBAC), value messaging , and publications A Team Approach Let our multidisciplinary team … state utilities you need to differentiate your product beyond its safety and efficacy profiles. We combine the …
… Submission Requirements of Nordic HTA Organizations for Medical Technologies Maria Kinderås, MSc Senior Associate, Market … – especially in the selection process – that will impact evidence generation needs and submission planning. …
… HTA Processes for Medical Technologies Across the World – Are All Hurdles the Same? … whereas European HTAs consider other economic elements beyond QALYs. HTA review times vary across and within …
… to help commercialize your products. Located in the US, UK, Germany, Spain, and Sweden , our team of over 60 health … demonstrate the economic value of your pharmaceutical and medical products. Expertise for Every Product Lifecycle Stage … cost-consequence, budget and population health impact, and value-based pricing Comparative Effectiveness …
… Disease prevalence and incidence Treatment patterns, impact, and adherence Product safety and risk minimization … and retention Statistical analysis plans Reports and publications Data Collection and Management Depending upon … includes customizing and employing the following technologies: Laptop and tablet applications Electronic data …
… Publication Management and Medical Writing Publications are critical for the … revisions at the revision stage Upon Acceptance Providing guidance on Open Access license options Reviewing the article …