Regulators have made it abundantly clear - through recent guidance and inspection findings - that demonstrating sponsor oversight of an outsourced study is a critical requirement for TMF health and inspection-readiness.
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The Date of Application for Medical Device Regulation 2017/745 established several new documents and support services to help manufacturers adjust to the new regulatory environment.
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Jax
Do you need reliable pharmacokinetic data (PK) to evaluate human immunoglobulin or albumin-based therapeutic drug candidates? The humanized FcRn (Hu-FcRn) mouse model enables you to obtain clinically-relevant PK data related to drug half-life. This critically important PK data helps optimize the design of preclinical efficacy studies and to de-risk lead selection.
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questexweb
Like many health plans, engaging and activating vulnerable populations at scale is critical to Home State Health. Tailored conversations through text messaging between the health plan and the individual improves member engagement, which leads to improved quality measures and health outcomes. Advances in Conversational AI enable Home State Health to deliver meaningful dialogue that address multiple topics, incorporate Social Determinants of Health (SDOH) and drive member action.
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