FDA has published a new paper bringing together key considerations for developing and using digitally derived measures as outcomes in clinical investigations, including measures captured through digital health technologies and AI-enabled tools.
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A recent Phase 2b cardiovascular study at Wellness Clinical Research moved from site selection to activation in 28 days, followed by the first participant screening 15 days later.
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Following the first screening on August 27, the Wellness Clinical Research team screened three additional participants the next day and another on September 3.
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FDA's May 2026 final technical specifications describe how continuous glucose monitoring data should be structured and submitted in clinical trials supporting drug and biologic marketing applications.
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Wellness Clinical Research Principal Investigator Dr. Gustavo Albizu-Angulo is listed among the SURMOUNT-5 Trial Investigators in the New England Journal of Medicine publication comparing tirzepatide and semaglutide for obesity.
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Dr. Lucky Flores is named among the ECOSPOR III and ECOSPOR IV investigators in a 2024 peer-reviewed analysis of a microbiome therapeutic for recurrent Clostridioides difficile infection.
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Dr. Gustavo R. Albizu-Angulo is listed among the SURMOUNT-4 investigators in the JAMA publication evaluating continued tirzepatide treatment for maintenance of weight reduction in adults with obesity.
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Wellness Clinical Research investigators Dr. Lucky Flores and Dr. Gustavo Albizu-Angulo are listed as authors on published Phase II research evaluating neihulizumab in treatment-refractory ulcerative colitis.
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Dr. Lucky Flores is listed in the investigator supplement for a randomized Phase 2 Gastroenterology study evaluating mirikizumab in patients with moderate-to-severe Crohn’s disease.
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Dr. Lucky Flores is listed among the JADE COMPARE investigators in the New England Journal of Medicine publication evaluating abrocitinib, dupilumab, and placebo in moderate-to-severe atopic dermatitis.
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Wellness Clinical Research investigators Dr. Lucky Flores and Dr. Gustavo Albizu-Angulo are named authors on a Gastroenterology abstract evaluating ustekinumab in Crohn’s disease with and without concurrent autoimmune skin manifestations.
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