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.
- 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
- Don't Let The Nocebo Effect In Psychedelic Trials Become A Regulatory Problem
- Are You Liable? What All Clinical Stage Companies Should Understand About Risk Disclosure
GUEST COLUMNISTS
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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.
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![Person Donating Blood-GettyImages-2246332353]( "Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The Clinic")
Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The ClinicTr1X Bio Co-founder and CEO David de Vries explains how moving Type 1 regulatory T Cell (Tr1) therapies into new indications reshapes every facet of first-in-human trial design.
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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")
PolarityBio Loosens I/E And Taps Many Provider Types To Reach More PatientsDiscover 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.
CLINICAL TRIAL WHITE PAPERS
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![Pipette With Cell Culture Plate-GettyImages-520238063]( "4 New Approvals In Q3 Across Gene, Cell, RNA Therapies")
4 New Approvals In Q3 Across Gene, Cell, RNA TherapiesQ3 2025 brought notable progress across the gene, cell, and RNA therapy landscape, marked by four new global approvals. While regulatory progress continued, clinical development activity slowed.
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A New Approach To Dynamic Clinical Oversight With Centralized Insights7/10/2025
RBQM is transforming clinical trial oversight. By automating protocol digitalization, site selection, and risk assessments 360° Monitoring enables the proactive identification of CtQ factors.
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Reimagining Medical Monitoring In Clinical Research4/11/2025
Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
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The Real Cost In CNS Trials: Rater Drift And Site Readiness11/21/2025
Learn how to build resilience into CNS trial operations with evidence-based frameworks that prioritize human factors alongside digital tools.
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The Future Of Regulatory Operations6/3/2024
The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.
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A Guide To Streamlining Study Start-Up In Australia9/23/2025
Discover the benefits of Australia as a premier destination for multinational sponsors looking to expedite drug development, refine trial design, and establish long-term research partnerships.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Expanding Clinical Research In East Africa With Digital Innovation12/11/2025
Africa carries 25% of the world’s disease burden but hosts only 1% of clinical trials. Discover technology-driven strategies that close this gap and transform research access in underserved regions.
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Solutions To The Challenges Of Oncology Trials5/6/2025
This significant Phase III trial, one of the largest global studies in head and neck cancer, faced considerable challenges including enrollment delays and an intricate study design.
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How Compassion Shaped This Pediatric Rare Disease Trial6/11/2025
Learn how kindness transformed the clinical trial experience for pediatric rare disease participants in a global study.
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Analytics–Powered Approach To Patient Recruitment Strategy7/15/2025
In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.
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Achieving A 2.67x Reduction In Study Build Time For An Innovative Neuromodulation Study12/20/2024
This study explores the potential of Focused Ultrasound Neuromodulation in deepening meditative states, and the platform that helps enhance the overall experience for researchers and participants alike.
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Rescue Studies: Get Patient Recruitment Back On Track9/22/2025
What is a rescue study, and how can direct-to-patient digital recruitment be employed to rapidly boost recruitment and enrollment?
NEWSLETTER ARCHIVE
- 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
- 03.24.26 -- The Uncomfortable Conversation: AI And Data Use 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.
-
![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.
-
![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.
-
![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.
-
![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.
