SIP users Sophie Haynes and Vicki Alvarez identify features that provide value but question whether the platform eliminates enough work to justify its setup demands, repetitive processes, and usability challenges.
- The Promise Of MRD-Guided CAR-T Treatment
- Your Trial Shows Up In AI. Now What?
- Dose Escalation, Combination Strategy Keep Aprea Ahead In Its Oncology Trials
- How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial Infrastructure
- The SIP Problem Is Bigger Than SIP
- Lessons In Forecasting Discipline From A $40B Supply Chain
- The Pharmacy Benefit No One Is Managing: Clinical Research As A Care Option
GUEST COLUMNISTS
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The Pharmacy Benefit No One Is Managing: Clinical Research As A Care Option
Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
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Planning A Global Clinical Trial With The Right Sites, Not The Most Sites
Less is more for Yi Larson and the team at Excursion Therapeutics, which opted to build right site network — not the largest one — for its Phase 2 trial.
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Turning Pediatric Cancer Discoveries Into Medicines Requires Better Connections
Promising pediatric cancer science often stalls before patients benefit. David Adler explains how better connections could change that.
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Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
How can sponsors revive a promising modality with known safety limits? Vast Therapeutics CEO Nate Stasko, Ph.D., explains how ALX1 is reshaping nitric oxide delivery.
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It Is Time To Require Human-Relevant Efficacy Evidence Before First-In-Human Trials
Why, when human-relevant evidence of likely efficacy can be generated before a trial begins, is it not evaluated before patients are exposed?
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Immune Priming, Oncolytic Viruses, And The Next Phase Of Solid Tumor Immunotherapy
Can priming with oncolytic viruses be a better path to reeducating the immune system to recognize and attack cancer? Oncolytics Biotech advisor Richard Vile, Ph.D., says yes.
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4 Ways That AI And Point-Of-Care Diagnostics Are Redefining Clinical Trial Design And Operations
Discover how AI-enhanced point-of-care diagnostics are changing trial design and what ClinOps should do next.
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What BriaCell's Trial Design Says About Real-World Cancer Research
BriaCell President and CEO William Williams, MD, shares how broader eligibility criteria and physician’s choice controls can better reflect real-world cancer care.
CLINICAL TRIAL WHITE PAPERS
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Hospital-Based eCOA Implementation: Real Challenges In Infectious Disease Trials
This resource outlines proven strategies to reduce delays, improve compliance, and meet regulatory standards for PRO data in infectious disease studies.
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Demonstrating IDS Value With Time-Based Metrics6/10/2026
Explore how leading IDS pharmacies are using remote monitoring workflows and digital accountability systems to improve accuracy, reduce site burden, and maintain audit readiness.
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Proving The Return On Investment For eRegulatory1/22/2025
Explore a study of how leading research centers, CROs, and sponsors cover the cost of eRegulatory tools … and then some.
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The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality11/18/2024
Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.
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Writing An IND Module 3 For Cell And Gene Therapy Products9/1/2025
This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.
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What Is ICH GCP, And How Does It Impact Clinical Planning?10/20/2025
The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration5/27/2026
Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.
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Improving Clinical Research Efficiency And Access For Underserved Populations3/26/2026
Modernizing data workflows removes geographic barriers to clinical trials, ensuring rural patients access innovative care while reducing administrative burdens on dedicated research staff.
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Successful SwissMedic Marketing Authorization Application For An Oncology Therapy6/4/2026
See how strategic EU dossier adaptation and Swiss-specific regulatory expertise enabled a successful SwissMedic submission and accelerated market access for an oncology therapy.
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Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research10/6/2025
By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.
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Inspection Facilitation Without Local MAH Presence5/26/2026
Local expertise and centralized oversight ensured compliant, well‑coordinated inspections across countries, reducing operational risk and client burden while maintaining consistent authority engagement.
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Trial Rescue And Reconnaissance4/15/2026
Explore a strategic partnership that resulted in a rescue plan for a Phase III oncology trial that was facing high site decline rates.
NEWSLETTER ARCHIVE
- 09.03.26 -- Faster FDA Pathways, Smarter Partnerships: Rethinking How Trials Get Done
- 09.03.26 -- Finding The Right Trial Model For Better Study Outcomes
- 09.02.26 -- Can Digital Endpoints Really Accelerate Clinical Trials?
- 09.02.26 -- This Isn't Just A Compliance Exercise
- 09.01.26 -- Cut The Chaos: Smarter Systems For Sites, Sponsors, And Data
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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AI visibility isn’t just about being found. Ross Jackson coaches sponsors on how to influence AI to provide clear stakeholder pathways for clinical trial involvement.
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AI can explain your trial — but can it help patients act? Ross Jackson shares how sponsors can turn visibility into trust and next steps.
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Early and ongoing patient engagement is a crucial component to staving off recruitment trouble and securing proper patient representation. Boehringer Ingelheim's Karen Correa, Ph.D., explains how.
FOCUS ON PATIENTS
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Minimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.
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Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
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Why, when human-relevant evidence of likely efficacy can be generated before a trial begins, is it not evaluated before patients are exposed?