The DTRA has released a detailed playbook to help clinical research sites use their own validated technology in sponsor-led trials. The "Bring Your Own Technology" (BYOT) model aims to reduce tech overload at sites, improve efficiency, and preserve regulatory compliance — starting with eConsent as its first use case.
- 4 Centralized Comparator Sourcing Models To Fortify Supply Chains
- How To Avoid Hazards And Map A Safer, Smarter Path For AI, Part 2
- How To Avoid Hazards And Map A Safer, Smarter Path For AI, Part 1
- Clinical Trials Get A Council For AI Oversight
- From Protocol To People: Teva's Patient-First Clinical Trials Approach
- A Guide To Guidelines: How ICH And Others Help Us Conduct Better Trials
- How An Australia-First Strategy Cut 63% From Our R&D Spend
GUEST COLUMNISTS
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![Australia map with pharmacy sign-GettyImages-994171800]( "How An Australia-First Strategy Cut 63% From Our R&D Spend")
How An Australia-First Strategy Cut 63% From Our R&D SpendEtira CEO Russell Hayward explains how conducting the company's early-stage trials in Australia has yielded big savings, shortened timelines, and produced FDA-ready data.
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![Womens health, medical research-GettyImages-1684528840]( "Imunon Talks Passionate PIs, Endpoint Selection In Frontline Ovarian Cancer Trials")
Imunon Talks Passionate PIs, Endpoint Selection In Frontline Ovarian Cancer TrialsIMUNON CEO Stacy Lindborg, Ph.D. details the company’s successes in site selection, as well as trial design and execution, in Phase 2 and 3 trials for IMNN-001, a frontline treatment for ovarian cancer.
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![GettyImages-1416039261]( "Dear Pharma, The Creator Economy Is NOT Only For Beauty")
Dear Pharma, The Creator Economy Is NOT Only For BeautyEmpactful Ventures CEO Denise N. Bronner has a message for pharma when it comes to influencer marketing: Adapt or become invisible. Here, she details the hazards of overlooking this powerful media channel.
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![Healthy gut, food-GettyImages-1301830934]( "2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination Diets")
2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination DietsVibrant Wellness clinical coordinator Suzanne Barker, MS, RDN, LDN, CGP, discusses how they faced and resolved two key issues when conducting a food sensitivity clinical trial.
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![Headache, cerebral hemorrhage, brain stroke-GettyImages-609441144]( "Accurate Diagnosis And Enrollment Criteria Improve Intracerebral Hemorrhage Research")
Accurate Diagnosis And Enrollment Criteria Improve Intracerebral Hemorrhage ResearchCEO Marc Deschamps shares how ischemic stroke treatment has overshadowed that of intracerebral hemorrhage, negatively impacting recruitment for ICH clinical trials. To turn the tide, he advocates for accurate diagnoses, more specialized care, and less restrictive enrollment criteria.
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![light bulb, idea-GettyImages-2151600503]( "Hey, What's The Big Idea? Patient Enrollment Utterly Reimagined, That's What")
Hey, What's The Big Idea? Patient Enrollment Utterly Reimagined, That's WhatWhat do air traffic control, nuclear power plants, and aircraft carriers have in common? Patient recruitment expert Tatty Scott argues clinical researchers should look at these industries to inspire more precise trial execution.
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![rosendal_acronymsoup]( "Breaking Free From The Acronym Soup: Rethinking The Role Of Technology In Clinical Trials")
Breaking Free From The Acronym Soup: Rethinking The Role Of Technology In Clinical TrialsAscendis Pharma's Ivanna Rosendal details how clinical systems hinder clinical trial execution and why we should rethink how technology can support our trials.
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![Gilead PBC 1]( "Gilead Art Campaign Captures The PBC Patient Experience, Inspires Patient-Centric Trials")
Gilead Art Campaign Captures The PBC Patient Experience, Inspires Patient-Centric TrialsGilead’s Carrie Frenette discusses the company's art campaign centered on primary biliary cholangitis to bring awareness to the condition and create more patient-centric trials for patients.
CLINICAL TRIAL WHITE PAPERS
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![Market Access Planning_Getty-1482999252]( "2024 Market Trends In Clinical Trials: Navigating The Future With Ease")
2024 Market Trends In Clinical Trials: Navigating The Future With EaseExplore this year’s market trends survey for a comprehensive analysis of the emerging trends, evolving preferences, and key challenges set to shape the future of clinical trial processes.
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Closing The Gap In Our Understanding Of Sleep Health With DHTs4/26/2024
This article delves into the current state of sleep assessments in clinical trials, advocates for a broader understanding of sleep, explores opportunities presented by wearable digital health technologies and examines regulatory expectations.
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Navigating The European Market's Regulatory Complexities12/30/2024
Prepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.
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Navigating The Evolving Landscape Of Immunotherapy in Oncology3/17/2025
Immunotherapy is revolutionizing oncology, enhancing patient outcomes through targeted treatments. This evolving landscape includes checkpoint inhibitors, and personalized medicine, shaping the future of cancer care.
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Decisions In Cell And Gene Therapy Development7/2/2024
Explore critical decisions across clinical trial design, patient recruitment, site selection, logistics, manufacturing, and long-term follow-up, aiming to guide stakeholders through CAGT development.
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Rare Disease – 2018-2022 Global Clinical Trial Landscape11/7/2023
Discover why the collaboration and expertise of organizations are vital in advancing rare disease research and improving the lives of millions affected.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Breaking Free From Process Paralysis In Clinical Trials1/13/2025
Explore the implementation of CRIO’s eSource solution by a leading pharmaceutical company to overcome process paralysis in clinical research.
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Use Case: A Patient-Centric Approach To Site Selection1/27/2025
Discover how Citeline’s robust datasets, combined with real-world data, inform intelligent site and investigator selection for a rare, autoimmune disease.
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RTSM Manages Clinical IP Dispensation In Schizophrenia Study8/30/2023
Challenged by the dispensation of an investigational product (IP) across diverse patient subgroups, see what solution this pharma was able to utilize to ensure optimal distribution and minimize wastage.
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Treatment Benefits Of Wearable DHTs For Patients With Cancer Cachexia11/20/2024
Wearable digital health technologies (DHTs) played a crucial role in assessing patient-centric outcomes during pfizer's study into the benefits of using ponsegromab for treating cancer cachexia.
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Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments1/15/2025
Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
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Blinded Randomization And Trial Supply Management Gets Support11/17/2023
Uncover how this global specialty pharmaceutical company was able to ensure the confidentiality of its blinded study data while receiving flexible and scalable unblinded support.
NEWSLETTER ARCHIVE
- 07.18.25 -- Never Underestimate The Power Of Clinical Operations
- 07.17.25 -- Composition Statements Of Ingredients In Labeling In NDAs And ANDAs
- 07.16.25 -- 2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination Diets
- 07.16.25 -- STREAM Edition: The Real Reason Why You Should Participate In Clinical Research
- 07.15.25 -- What's The Risk Of Letting Researchers Use LLMs?
RECRUITMENT AND DIVERSITY
This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.
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![Womens health, medical research-GettyImages-1684528840]( "Imunon Talks Passionate PIs, Endpoint Selection In Frontline Ovarian Cancer Trials")
IMUNON CEO Stacy Lindborg, Ph.D. details the company’s successes in site selection, as well as trial design and execution, in Phase 2 and 3 trials for IMNN-001, a frontline treatment for ovarian cancer.
-
![GettyImages-1416039261]( "Dear Pharma, The Creator Economy Is NOT Only For Beauty")
Empactful Ventures CEO Denise N. Bronner has a message for pharma when it comes to influencer marketing: Adapt or become invisible. Here, she details the hazards of overlooking this powerful media channel.
-
![Headache, cerebral hemorrhage, brain stroke-GettyImages-609441144]( "Accurate Diagnosis And Enrollment Criteria Improve Intracerebral Hemorrhage Research")
CEO Marc Deschamps shares how ischemic stroke treatment has overshadowed that of intracerebral hemorrhage, negatively impacting recruitment for ICH clinical trials. To turn the tide, he advocates for accurate diagnoses, more specialized care, and less restrictive enrollment criteria.
FOCUS ON PATIENTS
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![distraught woman in therapy session-GettyImages-973286132]( "More Personalized, Precision Medicine Needed In Psychiatry Clinical Trials")
Arrivo Bioventures' Joel Raskin, MD, and Greg Rigdon, Ph.D., discuss the importance of personalized and precision medicine in psychiatry clinical trials.
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![Teenager blood test-GettyImages-1780575106]( "From Protocol To People: Teva's Patient-First Clinical Trials Approach")
Teva Pharmaceuticals' Head of Global Early Clinical Development Eran Harary, MD, shares how the company approaches drug development by getting patient input early and often.
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![Healthy gut, food-GettyImages-1301830934]( "2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination Diets")
Vibrant Wellness clinical coordinator Suzanne Barker, MS, RDN, LDN, CGP, discusses how they faced and resolved two key issues when conducting a food sensitivity clinical trial.
CONTENT COLLECTIONS
2024 CRO LEADERSHIP AWARDS
See who the winners are of the 2024 CRO Leadership Awards.
