https://wellnessclinicalresearch.com Clinical research insights, investigator publications, study milestones, and Wellness Clinical Research news. en-us Fri, 11 Sep 2026 22:24:40 GMT https://wellnessclinicalresearch.com/blog/ai-clinical-trial-recruitment-referral-conversion https://wellnessclinicalresearch.com/blog/ai-clinical-trial-recruitment-referral-conversion Fri, 11 Sep 2026 12:00:00 GMT Recent AI recruitment announcements are shifting attention toward faster patient identification. The harder operational question is whether sites can review, contact, qualify, and support those referrals without losing participants in the handoff. Patient Recruitment and Site Operations https://wellnessclinicalresearch.com/blog/clinical-trial-source-preparation-startup-bottleneck https://wellnessclinicalresearch.com/blog/clinical-trial-source-preparation-startup-bottleneck Fri, 11 Sep 2026 12:00:00 GMT Recent industry attention has focused on a frequently overlooked part of study startup: translating the protocol and supporting manuals into source documents that staff can reliably use. Here is why that work delays enrollment, creates quality risk, and deserves earlier sponsor, CRO, and site coordination. Clinical Trial Site Operations https://wellnessclinicalresearch.com/blog/fda-hepatic-impairment-guidance-site-operations https://wellnessclinicalresearch.com/blog/fda-hepatic-impairment-guidance-site-operations Fri, 11 Sep 2026 12:00:00 GMT FDA’s September 2026 draft guidance on hepatic impairment studies highlights a site-level problem that is easy to underestimate: finding patients with liver disease is not the same as enrolling participants who can be classified consistently, matched appropriately, and dosed on schedule. Clinical Trial Operations https://wellnessclinicalresearch.com/news/fda-digitally-derived-measures-clinical-investigations https://wellnessclinicalresearch.com/news/fda-digitally-derived-measures-clinical-investigations Mon, 07 Sep 2026 12:00:00 GMT 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. Regulatory News https://wellnessclinicalresearch.com/news/43-days-site-selection-to-first-participant-screened https://wellnessclinicalresearch.com/news/43-days-site-selection-to-first-participant-screened Thu, 03 Sep 2026 12:00:00 GMT 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. Study Milestone https://wellnessclinicalresearch.com/news/five-participants-screened-by-september-3-cardiovascular-study https://wellnessclinicalresearch.com/news/five-participants-screened-by-september-3-cardiovascular-study Wed, 02 Sep 2026 12:00:00 GMT Following the first screening on August 27, the Wellness Clinical Research team screened three additional participants the next day and another on September 3. Screening Milestone https://wellnessclinicalresearch.com/blog/inspection-readiness-fda-gcp-trial-operations https://wellnessclinicalresearch.com/blog/inspection-readiness-fda-gcp-trial-operations Thu, 20 Aug 2026 12:00:00 GMT FDA’s increased focus on inspectability and data integrity has an immediate operational implication: sponsors and sites must know where critical records originate, who controls them, and whether they can be reconstructed before the first participant is enrolled. Quality and Compliance https://wellnessclinicalresearch.com/blog/site-payment-performance-clinical-operations-metric https://wellnessclinicalresearch.com/blog/site-payment-performance-clinical-operations-metric Sat, 15 Aug 2026 12:00:00 GMT Payment delays are often treated as a finance problem. At the site level, they affect staffing, participant reimbursements, vendor readiness, study prioritization, and the administrative capacity available for trial execution. Sponsors and CROs should measure payment performance as closely as other operational indicators. Clinical Trial Site Operations https://wellnessclinicalresearch.com/blog/fda-oncology-eligibility-guidance-site-operations https://wellnessclinicalresearch.com/blog/fda-oncology-eligibility-guidance-site-operations Sat, 01 Aug 2026 12:00:00 GMT FDA’s three final oncology eligibility guidances encourage more deliberate use of performance status, laboratory thresholds, washout periods, and concomitant medication exclusions. The operational lesson is clear: broader eligibility can improve access and accrual, but only when protocols, feasibility assumptions, screening workflows, and participant support are designed together. Clinical Trial Operations https://wellnessclinicalresearch.com/blog/digital-health-technology-trial-operations-readiness https://wellnessclinicalresearch.com/blog/digital-health-technology-trial-operations-readiness Sat, 25 Jul 2026 12:00:00 GMT FDA’s latest digital health technology initiative reinforces an operational reality: remote data collection succeeds only when sponsors and sites plan for participant support, missing data, device changes, safety review, and digital access before enrollment begins. Clinical Trial Operations https://wellnessclinicalresearch.com/blog/clinicaltrials-gov-modernized-prs-system-migration https://wellnessclinicalresearch.com/blog/clinicaltrials-gov-modernized-prs-system-migration Sat, 18 Jul 2026 12:00:00 GMT ClinicalTrials.gov began phasing out its Classic PRS workflow in July 2026. Sponsors and CROs should use the transition to tighten record ownership, site-to-sponsor reporting, amendment reconciliation, and submission quality before the next cutoff arrives. Quality and Compliance https://wellnessclinicalresearch.com/news/fda-cgm-data-clinical-trials https://wellnessclinicalresearch.com/news/fda-cgm-data-clinical-trials Thu, 11 Jun 2026 12:00:00 GMT 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. Regulatory News https://wellnessclinicalresearch.com/news/gustavo-albizu-surmount-5-trial-investigator https://wellnessclinicalresearch.com/news/gustavo-albizu-surmount-5-trial-investigator Tue, 13 May 2025 12:00:00 GMT 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. Investigator Publication https://wellnessclinicalresearch.com/news/lucky-flores-ecospor-phase-3-investigator https://wellnessclinicalresearch.com/news/lucky-flores-ecospor-phase-3-investigator Mon, 01 Jul 2024 12:00:00 GMT 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. Investigator Publication https://wellnessclinicalresearch.com/news/gustavo-albizu-surmount-4-jama-investigator https://wellnessclinicalresearch.com/news/gustavo-albizu-surmount-4-jama-investigator Wed, 13 Dec 2023 12:00:00 GMT 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. Investigator Publication https://wellnessclinicalresearch.com/news/flores-albizu-phase-2-ulcerative-colitis-publication https://wellnessclinicalresearch.com/news/flores-albizu-phase-2-ulcerative-colitis-publication Mon, 30 Jan 2023 12:00:00 GMT 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. Investigator Publication https://wellnessclinicalresearch.com/news/lucky-flores-mirikizumab-crohns-phase-2-investigator https://wellnessclinicalresearch.com/news/lucky-flores-mirikizumab-crohns-phase-2-investigator Mon, 08 Nov 2021 12:00:00 GMT 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. Investigator Publication https://wellnessclinicalresearch.com/news/lucky-flores-jade-compare-nejm-investigator https://wellnessclinicalresearch.com/news/lucky-flores-jade-compare-nejm-investigator Mon, 29 Mar 2021 12:00:00 GMT 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. Investigator Publication https://wellnessclinicalresearch.com/news/flores-albizu-ustekinumab-crohns-publication https://wellnessclinicalresearch.com/news/flores-albizu-ustekinumab-crohns-publication Mon, 04 May 2020 12:00:00 GMT 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. Investigator Publication