Learn how medical affairs can help oncology teams turn strong clinical evidence into real-world adoption by connecting development strategy with clinical practice.
- What Will Life Science Orgs Do When The AI Bill Comes Through?
- Clinical Trial Standards — What They Are And Why They're Indispensable
- Last-Mile Lessons For Depot-To-Site Delivery
- What SIP Gets Right And Where It Still Falls Short
- 5 Ways To Enrich The Clinical Trial Ecosystem
- Turn AI Visibility Into Action: Build Explanation Layers For Different Stakeholders
- Your Trial Shows Up In AI. Now What?
GUEST COLUMNISTS
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The Promise Of MRD-Guided CAR-T Treatment
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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Your Trial Shows Up In AI. Now What?
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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Dose Escalation, Combination Strategy Keep Aprea Ahead In Its Oncology Trials
Aprea’s Gene Kennedy explains how smart dose escalation, next-gen sequencing, and combination planning are helping the company advance its oncology trial for multiple solid tumor types.
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How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial Infrastructure
By pairing donor priorities with research needs at Children's National, Milken Institute SPARC is turning philanthropy into faster trials, stronger infrastructure, and long-term care goals.
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Lessons In Forecasting Discipline From A $40B Supply Chain
Forecasting errors rarely start with the algorithm. They start when protocol changes, enrollment and site data reach the supply plan too late to prevent waste and disruption.
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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.
CLINICAL TRIAL WHITE PAPERS
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Flexibility In Drug Development: From Tactical Response To Strategic Discipline
Historically managed through late-stage adjustments, operational adaptability has become a strategic imperative to prevent programs from stalling under real-world pressures.
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Designing More Representative Trials Through Strategic Planning5/28/2025
Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.
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A Promising Rebound in Clinical Trials10/23/2024
This report explores how clinical trials bounced back in 2023 from their decline a year earlier despite continued geopolitical, regulatory, and pricing pressures.
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Enhancing Clinical Trial Flexibility9/1/2025
Once seen primarily as staffing extensions, FSPs have evolved into strategic partners that deliver flexibility, scalability, and tailored expertise.
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Patient-Reported Outcome In Oncology Clinical Trials4/17/2025
As cancer therapies grow more complex and personalized, patient-reported outcomes (PROs) have emerged as a vital component of oncology research and care.
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De-Risking Early-Stage Biotech: Turning Vision Into Venture Capital9/3/2025
For early-stage biotech companies, transforming a scientific breakthrough into an investable asset requires more than compelling data—it requires a clear product vision.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Rescuing A Global Program For NDA Success8/12/2025
Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.
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Advancing Neuromuscular Research with Digital Endpoints1/20/2026
Explore cutting-edge digital measures that capture peak mobility and activity in real-world settings, offering meaningful insights into disease progression in neuromuscular disorders.
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Supporting Seamless Execution Across Early Phase Alzheimer's Trials7/31/2026
Enrollment hesitancy, staff turnover, and compressed timelines threatened a multi-phase Alzheimer's program. Learn the operational approach that delivered results at every stage.
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Medable's Japanese Clinical Trial Exceeds FPI Date And eCOA Adherence3/10/2025
A top-10 global pharma company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites in Japan. Explore an initiative to enhance the patient and site experience.
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Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission1/27/2026
Learn how to create a direct line from clinical planning and protocol design to clinical trial disclosure to optimize efficiency across the entire trial lifecycle.
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Unlocking Recruitment Potential In Trial-Naïve Sites4/17/2025
Site Professional Support enabled this late-phase rheumatoid arthritis study to conduct complex patient visits despite its use of sites that lacked research experience and resources.
NEWSLETTER ARCHIVE
- 09.12.26 -- Beyond Reviewing Data: RBQM And EDC Integration
- 09.11.26 -- Better Data, Faster Trials: How AI And Standards Are Reshaping Clinical Research
- 09.10.26 -- The Vanishing Middle: How Consultants And CROs Are Reshaping Clinical Trials
- 09.10.26 -- Solving The Complexities of Rare Disease Clinical Development
- 09.09.26 -- Where AI Risk Meets Patient Trust In Today's 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?