Discover how how federated data networks, platform aggregators, and collaborative partnerships have evolved to meet the data demands of modern product development, regulatory strategy, and commercial success.
- Research Center Layout Helps Lower Barriers To Cross-Industry Collaboration
- Elsa's AI Model Migration: Technical, Compliance, And Regulatory Risks For Sponsors (Part 2)
- Site Staffing On The Upswing, But Still A Challenge
- From Real-World Data To Real-World Impact: Building The Evidence Capability Pharma Actually Needs
- Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials
- A Clinical Machine Learning Operations (MLOps) Maturity Framework For Biopharma
- CROs, AI, And The New Economics Of Outsourcing
GUEST COLUMNISTS
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![anticancer drug, ADC-GettyImages-2148345960]( "Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials")
Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC TrialsZymeworks CMO Sabeen Mekan, MD, explores how scientific gains in ADC therapies have influenced first-in‑human trial design.
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![Data mining, artificial intelligence, machine learning, business analytics-GettyImages-1479759169]( "A Clinical Machine Learning Operations (MLOps) Maturity Framework For Biopharma")
A Clinical Machine Learning Operations (MLOps) Maturity Framework For BiopharmaPharma has invested substantially in machine learning applications, but investment in the operational infrastructure — the MLOps layer — has lagged. The time to build that infrastructure is now — not after your next trial fails.
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![Medical, psychological-GettyImages-2250633966]( "Don't Let The Nocebo Effect In Psychedelic Trials Become A Regulatory Problem")
Don't Let The Nocebo Effect In Psychedelic Trials Become A Regulatory ProblemWhen a patient feels no effect or a worsening effect because a known treatment effect was or wasn't experience, that's the "nocebo" effect. Strategic Advisor Jama Pittman discusses how this effect could impact regulatory reviews.
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![Risk-GettyImages-1396330691]( "Are You Liable? What All Clinical Stage Companies Should Understand About Risk Disclosure")
Are You Liable? What All Clinical Stage Companies Should Understand About Risk DisclosureBarnes & Thornburg partner Seth Mailhot provides a primer on risk disclosure and how sponsor companies can prepare for and mitigate issues that might arise.
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![EHR Checklist, secure digital workflow, medical records, patient date-GettyImages-2234691940]( "How Important Are Medical Monitors Under ICH E6(R3)?")
How Important Are Medical Monitors Under ICH E6(R3)?Discover how medical monitor-led implementation of ICH E6(R3) outperforms operations-only models across six critical performance dimensions.
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![bechtel getz series article 3]( "Old Habits, Communication Issues Still Stalling Site Budget Negotiations")
Old Habits, Communication Issues Still Stalling Site Budget NegotiationsDrawing from the 2025 SCRS Landscape Survey Report, Jimmy Bechtel and Ken Getz unpack how growing trial complexity, inconsistent fair market value benchmarks, and structural disconnects are reshaping site-sponsor relationships.
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![Gold key hung in the middle-GettyImages-1310224740]( "The Art Of Finding And Keeping The Right KOL")
The Art Of Finding And Keeping The Right KOLLearn from Incyclix CEO Patrick Roberts how the company identifies its KOLs, tailors engagement to their expertise, measures collaboration success, and sustains successful long-term partnerships.
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![Success Transformation, improvement, leadership-GettyImages-1417761158]( "What To Look For In Rare Disease Partnerships, With Origami's Beth Hoffman")
What To Look For In Rare Disease Partnerships, With Origami's Beth HoffmanOrigami Therapeutics CEO Beth Hoffman shares how the company took both a measured and a gut-feeling approach to finding the right partner to supports its development of protein degraders for neurodegenerative diseases.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1316437398-planning-strategy-data]( "Phase 1 Clinical Trial Designs And Strategies")
Phase 1 Clinical Trial Designs And StrategiesWith tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.
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GMP Compliance For Pharmaceuticals And Medical Devices3/14/2025
Good Manufacturing Practice (GMP) ensures products meet quality standards for their intended use, which covers all aspects of production. Explore how Ideagen supports GMP compliance across nine titles.
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Everest Group Life Sciences eCOA Peak Matrix Assessment 20259/16/2025
Discover how digital platforms are revolutionizing clinical trials by improving data quality and patient engagement in this comprehensive market assessment.
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Deriving Reliable Clinical Outcome Scores From Continuous DHT Data6/10/2025
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.
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Safeguarding Personal Data: Protecting PII8/4/2025
Learn about a secure, patient-centric platform that enables individuals to participate in clinical trials and registries while maintaining lifelong access to their data.
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Closing The Gap In Our Understanding Of Sleep Health With DHTs4/26/2024
What is the current state of sleep assessments in clinical trials, regulatory expectations, and what opportunities do wearable digital health technologies present?
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How A Rare Disease Biotech Replaced Manual Processes With RTSM Software3/26/2026
Discover how a clinical-stage biotech automated its supply chain to protect patient enrollment and eliminate manual errors in a complex, multi-national genetic medicine trial.
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Streamlining Global Respiratory Trial Complexities With Robust Data Capture Strategy9/23/2025
Want to see how eCOA solutions can simplify patient-reported data capture and accelerate global trials? Explore implementation strategies, lessons learned, and measurable results.
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Ergomed's Solutions To The Challenges of Oncology Trials4/15/2025
Explore a pivotal Phase III global clinical trial investigating neoadjuvant immunotherapy for locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).
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Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study4/15/2025
Discover how a clinical development program was saved using objective, continuous digital outcome measures.
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Expanding Access To Post-Market Safety Exams For Cystic Fibrosis Medication1/29/2025
This study highlights the transformative impact of point-of-need care on patient access, focusing on pediatric cystic fibrosis (CF) patients requiring essential eye exams.
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Cracking The Code: Strategies For Success In Complex Trials8/27/2024
Navigating the complexities of modern clinical trials requires advanced technology and strategic planning. Learn what goes into managing a challenging, decentralized rare disease trial.
NEWSLETTER ARCHIVE
- 03.30.26 -- Site Networks Scale For Consistency: Will Efficiency Follow?
- 03.27.26 -- What "AI-Ready Data" Really Looks Like
- 03.26.26 -- Engage Early With The FDA On AI … Or Expect Problems
- 03.25.26 -- U.S. Pharma Tariffs And MFN: Manufacturing And Procurement Impact
- 03.25.26 -- STREAM Edition: 3 Pillars Of Trustworthy AI In 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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![translate foreign language with internet software-GettyImages-2215567295]( "Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing")
Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
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![Gold key hung in the middle-GettyImages-1310224740]( "The Art Of Finding And Keeping The Right KOL")
Learn from Incyclix CEO Patrick Roberts how the company identifies its KOLs, tailors engagement to their expertise, measures collaboration success, and sustains successful long-term partnerships.
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![Doctor and patient in nursing home-GettyImages-1345138968]( "PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients")
Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.
FOCUS ON PATIENTS
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![translate foreign language with internet software-GettyImages-2215567295]( "Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing")
Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
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![Success Transformation, improvement, leadership-GettyImages-1417761158]( "What To Look For In Rare Disease Partnerships, With Origami's Beth Hoffman")
Origami Therapeutics CEO Beth Hoffman shares how the company took both a measured and a gut-feeling approach to finding the right partner to supports its development of protein degraders for neurodegenerative diseases.
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![Doctor and patient in nursing home-GettyImages-1345138968]( "PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients")
Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.
