{"version":"https://jsonfeed.org/version/1","title":"Fractional Clinical Operations Leadership & Governance | Choice ClinOps","home_page_url":"https://choiceclinops.com","description":"Fractional Clinical Operations Leadership & Governance | Choice ClinOps","author":{"name":"Fractional Clinical Operations Leadership & Governance | Choice ClinOps"},"items":[{"id":"https://choiceclinops.com/blog/f/should-environmental-exposure-data-be-included-in-your-trial","html_content":"

I walked into a room labeled monitoring area that looked like a repurposed closet. The flourescent lighting made a low buzzing sound similar to a fly. The site coordinator's nearby desk smelled like burnt coffee and hand...

","url":"https://choiceclinops.com/blog/f/should-environmental-exposure-data-be-included-in-your-trial","title":"Should Environmental Exposure Data be Included in Your Trial?","summary":"I walked into a room labeled monitoring area that looked like a repurposed closet. The flourescent lighting made a low buzzing sound similar to a fly. The site coordinator's nearby desk smelled like burnt coffee and hand...","date_modified":"2026-08-12T04:38:57Z"},{"id":"https://choiceclinops.com/blog/f/astrazeneca-and-bristol-myers-squibb-possible-3rd-largest-pharma","html_content":"

AstraZeneca and Bristol Myers Squibb: What We Know About the Reported $400 Billion Merger Talks

","url":"https://choiceclinops.com/blog/f/astrazeneca-and-bristol-myers-squibb-possible-3rd-largest-pharma","title":"AstraZeneca and Bristol Myers Squibb: Possible 3rd Largest Pharma","summary":"AstraZeneca and Bristol Myers Squibb: What We Know About the Reported $400 Billion Merger Talks","date_modified":"2026-08-03T14:15:30Z"},{"id":"https://choiceclinops.com/blog/f/fdas-new-vision-for-oncology-clinical-trial-eligibility","html_content":"

I have read a lot of clinical trial eligibility criteria in 24 years. I have also written a fair number of them, and I will confess something you may not hear often: some of draft and final protocol eligibility I receive...

","url":"https://choiceclinops.com/blog/f/fdas-new-vision-for-oncology-clinical-trial-eligibility","title":"FDA's New Vision for Oncology Clinical Trial Eligibility","summary":"I have read a lot of clinical trial eligibility criteria in 24 years. I have also written a fair number of them, and I will confess something you may not hear often: some of draft and final protocol eligibility I receive...","date_modified":"2026-07-30T18:25:11Z"},{"id":"https://choiceclinops.com/blog/f/july-20-26-2026-ma-signals-in-oncology-and-rare-disease","html_content":"

Executive Summary

","url":"https://choiceclinops.com/blog/f/july-20-26-2026-ma-signals-in-oncology-and-rare-disease","title":"July 20-26, 2026: M&A Signals in Oncology and Rare Disease","summary":"Executive Summary","date_modified":"2026-07-27T19:17:16Z"},{"id":"https://choiceclinops.com/blog/f/what-does-the-nvidia%E2%80%93kaist-ai-research-lab-deal-mean-for-clinops","html_content":"

By Leila Cupersmith, Founder & CEO, Choice ClinOps

","url":"https://choiceclinops.com/blog/f/what-does-the-nvidia%E2%80%93kaist-ai-research-lab-deal-mean-for-clinops","title":"What Does the NVIDIA–KAIST AI Research Lab Deal Mean for Clinops?","summary":"By Leila Cupersmith, Founder & CEO, Choice ClinOps","date_modified":"2026-07-24T15:50:29Z"},{"id":"https://choiceclinops.com/blog/f/why-arpa-hs-160m-thrive-program-should-be-on-every-rare-disease","html_content":"

Twenty-four years in clinical operations across oncology, rare disease, and cell and gene therapy trials has taught me one hard truth: the \"one disease, one drug, one trial\" model was never built for the patients who nee...

","url":"https://choiceclinops.com/blog/f/why-arpa-hs-160m-thrive-program-should-be-on-every-rare-disease","title":"Why ARPA-H's $160M THRIVE Program Should Be On Every Rare Disease","summary":"Twenty-four years in clinical operations across oncology, rare disease, and cell and gene therapy trials has taught me one hard truth: the \"one disease, one drug, one trial\" model was never built for the patients who nee...","date_modified":"2026-07-13T16:19:25Z"},{"id":"https://choiceclinops.com/blog/f/whats-the-difference-between-clinical-research-studies-trials","html_content":"

","url":"https://choiceclinops.com/blog/f/whats-the-difference-between-clinical-research-studies-trials","title":"What's the difference between clinical research, studies & trials","date_modified":"2026-06-28T00:08:01Z"},{"id":"https://choiceclinops.com/blog/f/cro-governance-that-works-a-practical-guide-for-sponsors","html_content":"

You outsourced to a CRO to reduce your internal burden. So why does oversight feel like a full-time job you don't have resources for?

","url":"https://choiceclinops.com/blog/f/cro-governance-that-works-a-practical-guide-for-sponsors","title":"CRO Governance That Works: A Practical Guide for Sponsors","summary":"You outsourced to a CRO to reduce your internal burden. So why does oversight feel like a full-time job you don't have resources for?","date_modified":"2026-02-13T15:24:48Z"},{"id":"https://choiceclinops.com/blog/f/the-takeda%E2%80%93iambic-ai-deal-is-a-clinops-wake-up-call","html_content":"

AI isn’t just accelerating drug discovery. It’s compressing the timeline to IND—and moving the bottleneck straight into clinical trial operations.

","url":"https://choiceclinops.com/blog/f/the-takeda%E2%80%93iambic-ai-deal-is-a-clinops-wake-up-call","title":"The Takeda–Iambic AI Deal Is a ClinOps Wake-Up Call","summary":"AI isn’t just accelerating drug discovery. It’s compressing the timeline to IND—and moving the bottleneck straight into clinical trial operations.","date_modified":"2026-02-11T01:24:15Z"},{"id":"https://choiceclinops.com/blog/f/time-toxicity-the-kpi-sponsors-dont-track-until-the-study-break","html_content":"

Most oncology and rare-disease sponsors measure enrollment, cycle time, and vendor performance.

","url":"https://choiceclinops.com/blog/f/time-toxicity-the-kpi-sponsors-dont-track-until-the-study-break","title":"Time Toxicity-The KPI Sponsors Don't Track Until the Study Breaks","summary":"Most oncology and rare-disease sponsors measure enrollment, cycle time, and vendor performance.","date_modified":"2026-01-15T15:27:58Z"},{"id":"https://choiceclinops.com/blog/f/the-26m-mistake-hiding-between-your-clinical-trial-vendors","html_content":"

Captain James commanded the research vessel Prometheus on its most critical voyage yet. Week 3: a junior engineer reported a small leak.

","url":"https://choiceclinops.com/blog/f/the-26m-mistake-hiding-between-your-clinical-trial-vendors","title":"The $2.6M Mistake Hiding Between Your Clinical Trial Vendors","summary":"Captain James commanded the research vessel Prometheus on its most critical voyage yet. Week 3: a junior engineer reported a small leak.","date_modified":"2025-12-31T00:49:53Z"},{"id":"https://choiceclinops.com/blog/f/how-can-sponsors-build-value-based-care-into-clinical-trials","html_content":"

Value-based care (VBC) is often framed as a reimbursement problem. In reality, patients and care teams experience it as an access + execution problem.

","url":"https://choiceclinops.com/blog/f/how-can-sponsors-build-value-based-care-into-clinical-trials","title":"How can sponsors build value-based care into clinical trials?","summary":"Value-based care (VBC) is often framed as a reimbursement problem. In reality, patients and care teams experience it as an access + execution problem.","date_modified":"2025-12-17T03:32:39Z"},{"id":"https://choiceclinops.com/blog/f/cro-oversight-steps-for-success-in-small-mid-size-oncology-trial","html_content":"

A VP of Clinical Operations at a 50-person oncology biotech running their second Phase 2 trial recently confided: \"Every metric is green, but I'm working 60-hour weeks just keeping things from falling apart. I can't tell...

","url":"https://choiceclinops.com/blog/f/cro-oversight-steps-for-success-in-small-mid-size-oncology-trial","title":"CRO Oversight: Steps for Success in Small-Mid-Size Oncology Trial","summary":"A VP of Clinical Operations at a 50-person oncology biotech running their second Phase 2 trial recently confided: \"Every metric is green, but I'm working 60-hour weeks just keeping things from falling apart. I can't tell...","date_modified":"2025-12-12T09:50:17Z"},{"id":"https://choiceclinops.com/blog/f/behind-the-scenes-operational-gene-therapy-study-rescue","html_content":"

When a pivotal gene therapy trial falls behind, timelines aren't the only thing at risk.

","url":"https://choiceclinops.com/blog/f/behind-the-scenes-operational-gene-therapy-study-rescue","title":"Behind The Scenes: Operational Gene Therapy Study Rescue ","summary":"When a pivotal gene therapy trial falls behind, timelines aren't the only thing at risk. ","date_modified":"2025-12-04T05:51:27Z"},{"id":"https://choiceclinops.com/blog/f/elevidys-boxed-warnings-and-future-dmd-gene-therapy-clinops","html_content":"

When a therapy carries both historic hope and a Boxed Warning, clinical trial operations move from “execution” to responsibility. That is exactly where the Duchenne community now stands with delandistrogene moxeparvovec ...

","url":"https://choiceclinops.com/blog/f/elevidys-boxed-warnings-and-future-dmd-gene-therapy-clinops","title":"Elevidys, Boxed Warnings, and Future DMD Gene Therapy ClinOps","summary":"When a therapy carries both historic hope and a Boxed Warning, clinical trial operations move from “execution” to responsibility. That is exactly where the Duchenne community now stands with delandistrogene moxeparvovec ...","date_modified":"2025-11-17T17:08:49Z"},{"id":"https://choiceclinops.com/blog/f/poll-results-are-in-poor-communication-tops-45%25","html_content":"

Two weeks ago, I, Leila Cupersmith, opened a poll on my LinkedIn profile to identify why clinical trial operations and data-management teams misalign.

","url":"https://choiceclinops.com/blog/f/poll-results-are-in-poor-communication-tops-45%25","title":"POLL RESULTS ARE IN: Poor Communication Tops 45%","summary":"Two weeks ago, I, Leila Cupersmith, opened a poll on my LinkedIn profile to identify why clinical trial operations and data-management teams misalign.","date_modified":"2025-10-24T02:01:09Z"}]}