When acquiring another company, the acquiring sponsor must preserve operational continuity across active trials while integrating new assets, teams, technologies, vendors, and decision structures. Leila Cupersmith explains how.
- Lessons In Pivoting From A Clinical Trial Launch In Uganda
- DDW 2026 Signalled The Next Era Of Competitive Landscape In IBD
- The Patient Recruitment Debate Nobody's Having
- What Is Computer Software Assurance, And What Are Its Benefits?
- The FDA Is Rudderless And Clinical Trials Are Left Adrift
- Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community
- What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026
GUEST COLUMNISTS
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What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026
On the heels of ISPOR 2026, discover what relevancy HEOR has in the world of clinical operations.
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Why Tolerability Will Drive The Next Wave Of Obesity Treatments
For the next generation of obesity medicines, enhancing how patients experience therapy will inform discovery and development efforts and may ultimately determine long-term success.
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Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid Tumors
Kivu Bioscience CEO Mohit Trikha, Ph.D., contends that safer ADCs enable higher effective dosing and could elicit a better response in solid tumors. In this Q&A, he also discusses how parallel trial execution, global site strategy, and stakeholder collaboration support rapid, data-driven development.
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Taking On Patient Recruitment From Another Angle — The Payer
Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment.
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Clinical Trial Ads, Informed Consent, And Half-Hearted Regulation
Should informed consent really start with clinical trials ads? And if not, why do IRBs need to be involved in their approval? Paul Ivisin unravels the tangled web of IRBs, regulators, and clinical trial advertisements.
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FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors
Discover five critical risks created by HALO's architecture and Elsa 4.0's expanded capabilities. Then, learn how to implement practical safeguards sponsors to implement immediately.
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Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials
BioAegis Therapeutics CEO Susan Levinson, Ph.D., talks about the role of partner and regulatory support in bringing their investigational immunotherapy into the clinic.
CLINICAL TRIAL WHITE PAPERS
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Understanding How To Build And Leverage A DSMB Statistical Plan
Get an overview of the essential components involved in providing independent statistical center support for a data safety monitoring board (DSMB), also known as a data monitoring committee (DMC).
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Bringing Clinical Trials To Everyone's Backyard1/10/2025
Learn how bringing clinical trials to any community around the world is not only possible but also increases patient access and reach and improves recruitment and retention.
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The Impact Of High Inflation And The Great Resignation On Clinical Site Budgeting10/30/2024
The twin pressures of inflation and attrition prolong negotiations between sponsors and clinical sites, stalling drug development. Sponsors need up-to-date, reliable benchmark data to negotiate fair market value budgets.
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How Adaptive Design Accelerates Early‑Phase NSCLC Development5/22/2026
Adaptive trial designs and an adaptive mindset enable non-small cell lung cancer (NSCLC) sponsors to optimize dose, respond to evolving expectations, and accelerate early‑phase development.
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10 Clinical Research Practices That Feel Like Compliance (But Aren't)3/24/2026
Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.
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Combination Therapy Dose Optimization In Oncology Trials3/30/2026
Optimize dose selection in oncology trials by moving beyond toxicity limits. Use advanced modeling and benefit-risk analysis to improve efficacy and meet modern regulatory standards.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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The Perfect Solution For Recruitment, Retention, And ROI8/15/2024
See how Citeline Connect was deployed to advance enrollment six months ahead of schedule for a sponsor’s Phase IV atopic dermatitis trial and build a community of engaged patients.
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FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study3/12/2026
Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.
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Enhancing Investigator Training And Communication During COVID-196/26/2024
Centralizing all trial-related information, enabling seamless interaction and global team coordination through Scout Academy.
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Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice10/30/2024
See how a pharma company reduced investigator payment cycle time by 55% while decreasing their own administrative burden by 90% in this metrics-rich case study.
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Drug-Drug Interaction Study On A Novel Cardiovascular Medication9/17/2024
Learn how Altasciences leveraged its expertise to design, recruit, and conduct complex DDI studies, assessing pharmacokinetic and pharmacodynamic impacts of co-administered drugs.
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Optimizing EDC Strategy And Data Collection for a Rare Disease Trial6/11/2025
Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.
NEWSLETTER ARCHIVE
- 06.05.26 -- FDA's Draft Guidance On Bayesian Methods
- 06.05.26 -- Distributing, Exchanging, And Managing Study Documents Electronically
- 06.04.26 -- Contracting For AI In Clinical Trials
- 06.04.26 -- Who Are Clinical Trials Really Reaching?
- 06.03.26 -- FDA Approval Is Not Synonymous With Commercial Success
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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Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.
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CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.
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Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment.
FOCUS ON PATIENTS
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CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.
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For the next generation of obesity medicines, enhancing how patients experience therapy will inform discovery and development efforts and may ultimately determine long-term success.
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Being time conscious and attuned to patient needs are two contributing factors to trials that recruit and retain patients for the duration.