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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![diversity - equality iStock-1303294233]( "Practical Strategies For Diverse Trial Recruitment")
Practical Strategies For Diverse Trial RecruitmentThe clock is ticking on the requirement for pharmaceutical companies to include FDA-mandated diversity action plans for pivotal studies in clinical trials.
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The Importance Of A Maturity Model For Clinical Trial Transparency10/23/2024
A comprehensive maturity model for clinical trial disclosure and transparency offers companies a strategic tool to assess and enhance their practices in an increasingly complex regulatory environment.
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Outlook Good For 7 Drugs Up For Q3 Review8/15/2024
A total of 24 drugs, devices, diagnostics, and deals are expected to progress in the third quarter of 2024, including approval applications for 17 drugs. The estimated overall likelihood of approval is 90% or higher for seven of those drugs, including revumenib for acute myelogenous leukemia and KarXT for schizophrenia.
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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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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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Guide To Pharmaceutical CAPA And Quality Management3/14/2025
CAPA management is vital for quality systems, especially in pharmaceuticals. Examine how issues are identified, corrected, and prevented to safeguard health and uphold regulatory compliance.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Enhancing Phase 1 Clinical Trials With Point-Of-Need Safety Assessments2/3/2025
A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.
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Pioneering The End-To-End Decentralized Trial Experience4/16/2025
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
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End-To-End Inventory Control Supports Biotech's Expanding Portfolio2/19/2026
Many organizations struggle with siloed operations, but this modern GxP inventory solution solves these challenges by providing a centralized, cloud-based platform for end-to-end visibility.
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Removing Translation Bottlenecks With AI8/8/2025
See how an AI-enabled approach eliminated the manual, time-consuming translation bottlenecks that often delay clinical trial launches.
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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.
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Transforming Clinical Supply Planning From Spreadsheets To Smart Forecasting11/17/2025
Streamline your clinical supply forecasting and reduce risk by moving beyond manual spreadsheets to an integrated, real-time supply management solution.
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.
