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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![ispor]( "What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026")
What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026On the heels of ISPOR 2026, discover what relevancy HEOR has in the world of clinical operations.
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![GLP-1 agonist injector pen, medical measuring tape-GettyImages-2226642622]( "Why Tolerability Will Drive The Next Wave Of Obesity Treatments")
Why Tolerability Will Drive The Next Wave Of Obesity TreatmentsFor 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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![Genetic engineering, GMO and Gene manipulation-GettyImages-1344879684]( "Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge")
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![Female doctor examining patient-GettyImages-2217109316]( "Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid Tumors")
Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid TumorsKivu 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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![Healthcare benefits enroll-GettyImages-882379348]( "Taking On Patient Recruitment From Another Angle — The Payer")
Taking On Patient Recruitment From Another Angle — The PayerMedzown 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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![IRB ad approval-Getty image 1075404882]( "Clinical Trial Ads, Informed Consent, And Half-Hearted Regulation")
Clinical Trial Ads, Informed Consent, And Half-Hearted RegulationShould 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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![5 AI FDA risks]( "FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors")
FDA's HALO Platform And Elsa 4.0: Five Critical Risks For SponsorsDiscover 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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![Human circulatory system, internal organs-GettyImages-2211665100]( "Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials")
Biotech Ecosystem Helps Advance A New Approach To Inflammation Into TrialsBioAegis 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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![GettyImages-638646884 medical team meeting]( "Breaking Through Barriers With Integrated Trial Optimization")
Breaking Through Barriers With Integrated Trial OptimizationIn 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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What Clinical Trial Decision Makers Are Prioritizing In 20255/7/2025
In 2025, clinical trial operations are undergoing a transformative shift driven by the need for speed, cost-efficiency, and patient-centered approaches.
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The Patient Experience Paradox: eCOA Strategy Overhaul3/25/2026
European regulatory shifts now require the systematic integration of patient data. Success depends on aligning clinical and market access strategies through rigorous evidence generation.
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Routes To Sponsor Of Choice: Shared Pipelines, Streamlined Payments10/30/2024
Paying clinical trial sites consistently on time provides stability and maintains positive relationships. Learn why being a sponsor of choice can mean the adoption of a singular clinical trial payments solution.
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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.
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Offline eCOA: The Real-Time Monitoring Dilemma3/9/2026
Balance the need for offline data safety with the necessity of real-time monitoring. Learn how to navigate new regulatory requirements for source devices while maintaining high patient compliance.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Scaling Success: A Blueprint For Flexible Biometrics Partnerships2/19/2026
Learn how a micro-FSP model and integrated biometrics team can scale from specialized support to a full-service solution, ensuring agility and consistency as clinical trial needs evolve.
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Study Analysis – Site Payment Automation12/8/2025
By removing administrative bottlenecks, see how automation improves cash flow for sites, reduces operational burden for sponsors, and supports smoother, more predictable trial execution.
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Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot8/19/2024
Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research efficiency.
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Flexible Data Management For Growing Portfolio7/31/2025
Explore strategic enhancements to a small biopharma's biometrics capabilities involving the deployment of 20 specialized professionals, which effectively bolstered the client’s organizational capacity.
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Optimized Processes: A Guide To Lyophilization Cycle Development6/25/2024
Review the essential phases of the lyophilization cycle — freezing, primary drying, and secondary drying — and critical success factors to achieve optimal product quality and stability.
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Outgrowing Excel: Implementing RTSM In A Live Phase I Trial2/25/2026
Learn how a clinical-stage oncology biotech successfully transitioned a live Phase I trial from manual spreadsheets to RTSM without disrupting site momentum or patient enrollment.
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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![child getting vaccine-GettyImages-1678122790]( "Lessons In Pivoting From A Clinical Trial Launch In Uganda")
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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![Tidioute Health Care Center-GettyImages-1273786594]( "Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community")
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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![Healthcare benefits enroll-GettyImages-882379348]( "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.
FOCUS ON PATIENTS
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![Tidioute Health Care Center-GettyImages-1273786594]( "Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community")
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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![GLP-1 agonist injector pen, medical measuring tape-GettyImages-2226642622]( "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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![Mother abd adult daughter at doctors-GettyImages-2213748134]( "Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS Study")
Being time conscious and attuned to patient needs are two contributing factors to trials that recruit and retain patients for the duration.
