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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Master Protocols: Implementing Effective Treatment Adaptations
From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.
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Clinical Trial Starts Rose At Slower Pace In 202412/8/2025
Clinical trial starts grew 5.5% to 10,503 in 2024, a slowdown from 2023’s 9.4% rise in trial starts. Sustained geopolitical and global regulatory pressures on pharma contributed to curbing momentum.
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Human-Centered RTSM Design Enhances Data, Safety, And Operations12/5/2025
Uncover how this human-centered approach to RTSM prioritizes user experience (UX) and interface design (UI) to reduce complexity, minimize errors, and improve compliance.
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Hospital-Based eCOA Implementation: Real Challenges In Infectious Disease Trials11/21/2025
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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Rethinking Trial Access Through Trust-Driven Design And Local Collaboration5/19/2026
Locally embedded research models help sponsors reach underserved populations while reducing burden on patients and health systems alike.
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What Is Healthcare Data Interoperability And Why Does It Matter For Clinical Research?1/28/2025
Explore how healthcare data interoperability can transform patient outcomes, streamline clinical research, and enhance efficiencies while addressing key challenges and global initiatives.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Scaling Investigational Drug Services: A Case Study in Overcoming Operational Bottlenecks8/20/2026
Are operational bottlenecks holding back your research site? Explore a blueprint for automating investigational product workflows and giving staff time back for patient care.
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Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia4/11/2025
Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.
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Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech10/2/2025
This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.
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Overcoming Participant Compliance Challenges In A Medical Device Study9/9/2024
Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.
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Maintain Compliance Through Divestiture Without Disrupting Operations6/25/2026
Facing a divestiture? Learn how to protect historical quality records and stay audit-ready throughout the transition.
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Finding An RTSM Software To Keep Up With A Small Biotech3/26/2026
Stop letting rigid RTSM builds stall your oncology trials. Learn how agile configuration and right-sized documentation keep Phase I studies on track during frequent protocol amendments.
NEWSLETTER ARCHIVE
- 09.04.26 -- Data Accuracy Meets Patient Access: Innovations Driving Clinical Trials Forward
- 09.04.26 -- From Intelligent RTSM To Inspection Readiness: Smarter Clinical Workflows
- 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?
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?