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
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
CLINICAL TRIAL WHITE PAPERS
-
Deriving Reliable Clinical Outcome Scores From Continuous DHT Data
DHT-derived endpoints, especially percentile-based metrics, hold promise for robust, scalable measurement in clinical trials—provided they're chosen statistically and with adherence in mind.
-
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.
-
2026 Clinical Trials: Strong Headwinds, Winds Of Change6/11/2026
Are your Phase I–III/IV clinical studies prepared for today's regulatory landscape? Learn how leading organizations are addressing compliance, transparency, and data ownership risks.
-
Participant Payments: Navigating Modern Studies12/18/2024
To address the challenges of disbursing clinical trial participant payments globally, sponsors need region-specific payment solutions that navigate local laws and banking systems.
-
Antibody-Drug Conjugates: 'Magic Bullets' Become Reality2/19/2025
Cancer therapy has evolved from potent chemotherapy to targeted biological therapy, including antibody-drug conjugates (ADCs). Learn more about ADCs’ makeup, mechanisms, and the development landscape.
-
Faster Starts, Stronger Finish: Operational Excellence In NSCLC5/22/2026
In NSCLC trials, data‑driven site selection, streamlined protocols, efficient screening strategies, and proactive engagement can accelerate enrollment and improve trial efficiency across regions.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Use Of Epiontis ID In A Phase 2 Psoriasis Trial9/25/2025
Mirikizumab’s Phase 2 trial explores IL-23 inhibition in psoriasis, measuring immune cell changes to assess its potential for long-term disease control and flare-up prevention.
-
Stabilizing A Biotech Sponsor's Data Management And Biostatistics Functions8/29/2026
Discover how a rapid mid-study data transition rescued an endangered clinical trial, cleaned up compromised data, and secured a critical interim database lock within twelve months.
-
Advancing IHC Assays From RUO To Clinical Trials And CDx8/21/2026
Examine how an exploratory IHC assay evolved into a multi-indication clinical program through integrated assay development, validation, regulatory strategy, and scientific collaboration.
-
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.
-
Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice10/30/2024
See how a pharma company reduced investigator payment cycle time by 55% while decreasing their own administrative burden by 90% in this metrics-rich case study.
-
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.
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.
-
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?