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… data analyses Clinical Study Reports (CSR) Support for regulatory agency submissions In addition, our statisticians …
… of the manufacturer. The process is kicked off when the regulatory dossier is submitted to the EMA. HTA Firmly in … efficacy and safety evidence submitted as part of the EMA regulatory dossier will effectively be mirrored in the JCA, …
… interviews, chart abstractions, etc.) Data management Regulatory support including preparing reports and responses to regulatory questions for studies that are conditions of drug …
… opportunities for joint HTA consultations with Canada, the US, Norway, Sweden, and Finland. In the event that the UK … helps in implementing appropriate study design for both regulatory and HTA purposes. However, advice that is sought …
… Measurement Strategies With a deep understanding of the regulatory environment and reimbursement issues pertaining to …
… management strategies throughout the product development, regulatory, and post-marketing lifecycle. …
… guidance about using real-world evidence (RWE) to support regulatory decision-making that includes considerations for … studies that use RWD and are intended for regulatory submission. The guidance emphasizes the … using RWD and RWE in regulatory submissions. Contact us to talk about how we can help with your RWD and RWE …
… FL Kristen Lentz is a Senior Data Protection and Regulatory Compliance Manager with RTI-HS. In this role, she reports to the Vice President of Legal and Regulatory Affairs. Kristen assists with development and maintenance of …
… Drug Safety in Pregnancy Satisfy Regulatory Requirements With Help From Our Perinatal … for an existing product, you will likely be required by regulatory agencies to assess the safety of your product if … authorities, so you can confidently partner with us to conduct the regulatory RWE research needed to meet …
… and Strategy Team Offers: Extensive experience developing publications in pharmacoepidemiology, patient-centered … tactical plans efficiently and effectively. The Complete Publications Experience RTI-HS partners with you to develop … through increased knowledge and understanding. Our publications support spans the whole asset lifecycle and is …