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… a global real-world study. Lin SH, Kahangire DA, Nagar S , Ahn M, Affi R, Agulnik J, Shih J, Hockmair MJ, Tufman A, …
… with our clients on projects to research rheumatology disease, rheumatology treatment, and complications and comorbidities of rheumatology disease. Our experience includes: Ankylosing spondylitis … arthritis Juvenile rheumatoid arthritis Muckel-Wells disease Types of Projects We have implemented studies to help …
… with MET exon 14 skipping (METex14). Furqan M, Karanth S, Goyal RK, Shih Y, Cai B, Rombi J, Davis KL, Caro N, Saliba …
Regulatory Priorities, Real-World Evidence, and the Safety and Effectiveness of COVID-19 Vaccines Share on: November 2, 2021 The ways COVID-19 vaccines are being administered have changed substantially in the last few months. Issues such as mixing and …
… range of therapeutic areas including chronic hand eczema, Alzheimer’s disease, non‒muscle invasive bladder cancer, multiple … measure for hypoparathyroidism. Ms. Crawford has a firm understanding of the challenges involved in selecting PRO …
… Men's Health A Wealth of Experience We have collaborated with our clients on projects researching men's health, diseases related to men's health, or complications … includes: Benign prostatic hyperplasia (BPH) Dupuytren's disease Erectile dysfunction Hip fractures Osteoporosis …
Webinar: Common Challenges & Solutions in Analysis of PROs in Oncology Clinical Trials Share on: Wednesday, March 21, 2018, 10 - 11am Watch the recording Unique Challenges with Patient-Reported Outcomes in Clinical Trials Collecting, analyzing, and …
… clients on projects to research hematology, hematologic treatments, and complications and comorbidities of …
… and ethnic minority groups as well. Conditions like heart disease, cancer, and diabetes, along with their contributing … sex, or age. Diversity Action Plan Requirements The FDA’s guidance outlines detailed expectations for DAPs. These … DAPs should include background information on disease understanding, associated risk factors, and demographic …
… from manufacturers well in advance of a product’s approval by the FDA so that they can make timely coverage … as a template for information in response to a payor’s request for a pre-approval “dossier.” Include these … data on file – at the discretion of the manufacturer Disease information Product information Version 4.1 (2020) …