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.
- 2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination Diets
- Accurate Diagnosis And Enrollment Criteria Improve Intracerebral Hemorrhage Research
- Hey, What's The Big Idea? Patient Enrollment Utterly Reimagined, That's What
- PI's CRAACO Model + AI = Rapid Enrollment
- Breaking Free From The Acronym Soup: Rethinking The Role Of Technology In Clinical Trials
- Gilead Art Campaign Captures The PBC Patient Experience, Inspires Patient-Centric Trials
- Population-Aware Medicine: Mitigating Racial Disparities In Efficacy And Accuracy
GUEST COLUMNISTS
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![Human crowd forming a big DNA symbol-[GettyImages-1129579152]( "Population-Aware Medicine: Mitigating Racial Disparities In Efficacy And Accuracy")
Population-Aware Medicine: Mitigating Racial Disparities In Efficacy And AccuracyMedicine is not one-size-fits-all. Here, strategic advisor Bill Hanlon implores pharma to develop therapeutics and diagnostics anchored by racial and ethnic diversity.
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![retro alarm clock-GettyImages-1161898895]( "It's Time To Change How We Engage Research Sites")
It's Time To Change How We Engage Research SitesSite operations expert Maria Ladd argues for a major change in how sponsors and CROs communicate and work with clinical research sites.
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![Pills, capsules, tablets, world-GettyImages-466783866]( "The Effects Of Most Favored Nation Drug Pricing On Clinical Trial Management")
The Effects Of Most Favored Nation Drug Pricing On Clinical Trial ManagementMarket expert Mathini Ilancheran explains how sponsors can mitigate the effects of "Most Favored Nation" drug pricing while maintaining trial integrity and accelerating time to market.
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![US flag capitol hill-GettyImages-1314505420]( "Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight")
Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future OversightRecent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.
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![FDA Headquarters Washington-GettyImages-1293101930]( "Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAs")
Understanding FDA's Draft Guidance: Composition Statements Of Ingredients In Labeling In NDAs And ANDAsThe FDA's 2024 draft guidance details presentation of a drug product’s composition and the corresponding details of the ingredients in the product labels for NDAs and ANDAs.
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![Document compliance, management, assessment-GettyImages-2208418097]( "How Is RIM Software Transforming Regulatory Compliance?")
How Is RIM Software Transforming Regulatory Compliance?Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.
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![Document Management Systems-GettyImages-2208418147]( "Why CRA Proficiency Needs A Boost From Better Assessment And Training")
Why CRA Proficiency Needs A Boost From Better Assessment And TrainingCRAs intend to fulfill clinical research’s commitment to patient safety. Yet, some fall short of true proficiency, and Gerald DeWolfe contends better evaluations and training can help.
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![European Union Flag, compass-GettyImages-1090057126]( "EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?")
EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?The EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials came into effect on July 1, 2025
CLINICAL TRIAL WHITE PAPERS
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![Bladder and Kidneys-GettyImages-1339092350]( "Bladder Cancer Global Clinical Trial Landscape (2024)")
Bladder Cancer Global Clinical Trial Landscape (2024)Bladder cancer is the ninth most common cancer in the world and thirteenth in mortality. This report provides a detailed overview of the clinical trial landscape for bladder cancer.
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The Annual Clinical Trials Roundup11/20/2023
Delve into in-depth analyses of key diseases, players, and geographies influencing the pharmaceutical industry through an overview of Phase 1–3 clinical trials initiated in 2022 across all therapeutic areas.
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Breaking Through Barriers With Integrated Trial Optimization5/9/2025
In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.
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Developing A Data Strategy For Clinical Trials9/20/2023
This white paper outlines a standardized method for developing a data strategy that can be tailored to a company's current needs and adapted as those needs evolve.
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How Early-Stage Planning Strategies Are Optimizing Drug Development5/12/2025
Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.
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Acute Myeloid Leukaemia: Global Clinical Trial Landscape (2024)4/8/2024
Learn how the collaboration among researchers, healthcare providers, and pharmaceutical industries holds promise for progress in Acute Myeloid Leukaemia management and care.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Decentralized Trials For Duchenne Muscular Dystrophy8/24/2023
Partnering with a global biotech, see how MRN was able to conduct 180+ monthly home visits to sustain trials for rare disease genetic medicine in vulnerable pediatric patients during COVID-19.
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Patient Insights Informed Consent Engagement9/18/2023
By incorporating the patient viewpoint throughout the informed consent process, discover how this technical solution enhanced the overall patient experience within clinical research operations.
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IP To Treat PFIC Approved With Support Of Customized Research Services7/14/2023
Find out how this biopharmaceutical company was able to evaluate a new drug's efficacy and safety for treating progressive familial intrahepatic cholestasis (PFIC) in a pediatric patient population.
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Cancer Research UK's Path To Rave EDC And The Medidata Platform6/17/2024
Discover how Cancer Research UK, the world's largest cancer charity, upgraded to Medidata's Rave EDC platform, streamlining clinical trials and enhancing productivity while ensuring minimal disruption.
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Using eConsent Data To Populate Site And Sponsor Data Systems10/7/2024
A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves. See how we accomplished it, using eConsent.
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U.S. Renal Care Achieves 75% Site Adoption Of eConsent5/1/2024
By dispelling prevalent misconceptions regarding participant age, cost, and complexity, see how this platform emerged as a versatile, rapid, and effective solution tailored to the unique needs of the elderly renal care population.
NEWSLETTER ARCHIVE
- 07.08.25 -- Breaking Free From The Acronym Soup
- 07.07.25 -- Why CRA Proficiency Needs A Boost From Better Assessment And Training
- 07.03.25 -- Navigate FDA Regulatory Changes
- 07.02.25 -- The Effects Of Most Favored Nation Drug Pricing On Clinical Trial Management
- 07.02.25 -- STREAM Edition: The Evolution Of Caregivers In Research
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.
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![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.
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![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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![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.
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![Gilead PBC 1]( "Gilead Art Campaign Captures The PBC Patient Experience, Inspires Patient-Centric Trials")
Gilead’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.
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![Human crowd forming a big DNA symbol-[GettyImages-1129579152]( "Population-Aware Medicine: Mitigating Racial Disparities In Efficacy And Accuracy")
Medicine is not one-size-fits-all. Here, strategic advisor Bill Hanlon implores pharma to develop therapeutics and diagnostics anchored by racial and ethnic diversity.
CONTENT COLLECTIONS
2024 CRO LEADERSHIP AWARDS
See who the winners are of the 2024 CRO Leadership Awards.
