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
-
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.
-
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.
-
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.
-
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.
-
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?
-
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.
-
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.
-
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
-
Designing More Representative Trials Through Strategic Planning
Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.
-
Empower Your Trial With Data And Evidence1/14/2026
Fuel your clinical development and decision-making with insights from fit-for-purpose data and evidence.
-
Practical Strategies For Diverse Trial Recruitment11/11/2024
The clock is ticking on the requirement for pharmaceutical companies to include FDA-mandated diversity action plans for pivotal studies in clinical trials.
-
How AI Is Reshaping Trial Design, Execution, And Disclosure9/25/2025
AI has quietly embedded itself into the operational heart of clinical development, where it is accelerating decisions, reducing manual burden, and improving outcomes.
-
Gene Therapies For Rare Diseases: Platforms, Modalities, And Delivery Systems10/6/2025
Examine the treatment landscape for rare diseases and the rapid evolution of gene therapy across three key dimensions: editing platforms, delivery modalities, and delivery vehicles.
-
5 Questions To Ask Before Selecting A Randomization Partner5/12/2026
Choose the right IRT partner for complex master protocols. Learn how adaptive randomisation expertise and flexible technology reduce disruption and keep trials execution-ready.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution8/18/2025
eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.
-
Delivering Complex Oncology Trials At Scale5/19/2026
Parexel delivered two complex, global Phase III prostate cancer trials by aligning site selection, logistics, imaging workflows, and RAM regulatory expertise—achieving faster enrollment and on‑time execution.
-
Targeted Indication Selection Using Adaptive Design8/12/2025
What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?
-
Accelerating Approval Pathway For Phase III Ovarian Cancer Trial8/29/2025
A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.
-
Leading Recruitment With A Strong Alzheimer's Referral Pool2/24/2026
A strong referral network helped the Gainesville site rapidly recruit pTau217‑positive Alzheimer’s participants while upholding high data quality, boosting enrollment and outperforming other sites.
-
Faster Trial Planning and Site Selection4/15/2025
Address the challenges of identifying the most suitable trial sites and investigators while optimizing feasibility planning, reducing screen failure rates, and improving patient retention.
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.
-
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.
-
AI can explain your trial — but can it help patients act? Ross Jackson shares how sponsors can turn visibility into trust and next steps.
-
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
-
Minimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.
-
Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
-
Why, when human-relevant evidence of likely efficacy can be generated before a trial begins, is it not evaluated before patients are exposed?