Is a vendor handoff really complete once the file is sent? Not quite. Sponsors still need context, ownership, and evidence to keep trials moving.
- What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care
- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
- C-Suite Changes Help Biotech Narrow Focus But Maintain Drive To Treat Fatal Neonatal Brain Injury
- 3 Ways To Solve Data Friction In Modern Clinical Data Management
- How Visible Is Your Clinical Trial To AI?
- The Rare Trials Summit Wants To Produce More Than Conversation
- Threat From Within: Why Biopharma's Drug Development Bottleneck Is Systemic
GUEST COLUMNISTS
-
![bottleneck, searchscope-GettyImages-2166479887]( "Threat From Within: Why Biopharma's Drug Development Bottleneck Is Systemic")
Threat From Within: Why Biopharma's Drug Development Bottleneck Is SystemicAs FDA timelines and AI-enabled development accelerate, biopharma’s biggest bottleneck may be its own ability to make earlier, cross-functional decisions.
-
![GettyImages-1826452239_data]( "Beyond Task Tracking: Why ClinOps Needs Dependency Intelligence")
Beyond Task Tracking: Why ClinOps Needs Dependency IntelligenceClinical trial operations will always need task tracking, but they're not enough on their own. Dependency intelligence shifts the focus toward readiness not reaction.
-
![Backpain-GettyImages-512749727]( "To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome Measures")
To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome MeasuresUNC researcher Irena Dujmovic Basuroski, MD, Ph.D., discusses why transverse myelitis remains difficult to study, how multicenter collaboration and adaptive trial designs may help, and why better clinical, patient-reported, and biomarker-based measures are essential to advancing treatment.
-
![medications in shopping basket-GettyImages-2281371864]( "From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams")
From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development TeamsAbbVie's Svetlana Kobina discusses how basket trials can help clinical development teams move from early clinical signals to a more disciplined strategy.
-
![GettyImages-2208609448_business]( "4 Hidden Gaps In Clinical Trial Preparation For Small Biotechs")
4 Hidden Gaps In Clinical Trial Preparation For Small BiotechsGaps are not always visible at the executive level, but their consequences are very real — affecting timelines, budgets, data quality, and ultimately the likelihood of regulatory success.
-
![pharmacist checks inventory, drug shelves-GettyImages-1941443650]( "ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive Malignancies")
ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive MalignanciesImvivaBio CMO Jan Davidson-Moncada, MD, Ph.D., discusses the company's Phase 1b/2 study for aggressive T-cell malignancies, explaining their unmet need, the rationale for an allogeneic approach, and how they plan to address immune rejection.
-
![Money, finance, economic value-GettyImages-2271167891]( "Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy")
Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor StrategyWith the help of Beroe Inc.'s Surya Ponnam, discover how per-patient cost (PPC) analytics is evolving into a core capability for balancing cost, quality, speed, and patient outcomes.
-
![Cancer Outpatient During Chemotherapy IV Infusion-GettyImages-1263248921]( "Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer Patients")
Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer PatientsCEO Jay Lalezari and CFO Robert E. Hoffman share how CytoDyn meet patient needs when they approach trial design for cancer trials.
CLINICAL TRIAL WHITE PAPERS
-
![clinical-ecoa-GettyImages-2255935744]( "The eCOA Iceberg")
The eCOA IcebergUnderstand the true cost of eCOA deployment, beyond software licenses, to reduce protocol risk, avoid operational bottlenecks, and protect study timelines and data quality.
-
Open-Label Study Assessing Relative And Absolute Bioavailability1/26/2026
Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.
-
De-Risking The Neurology IND: Lessons From Early FDA Engagement5/27/2026
Learn how early FDA alignment can help your neurology program move forward with greater clarity, confidence, and regulatory readiness.
-
2026 State Of Clinical Trial Technology: The Five Strategic Imperatives3/12/2026
AI acceleration and digital fragmentation are reshaping clinical trials. Discover five imperatives driving interoperability, smarter site enablement, and data‑ready workflows for future‑ready operations.
-
Five Preventable Clinical Design Pitfalls And How To Avoid Them7/21/2026
While late-stage trial attrition is often attributed to inadequate safety or efficacy, the true failure may be insufficient upstream planning and/or misalignment between clinical and commercial goals.
-
A New, AI-Augmented Horizon For Safety And Pharmacovigilance1/6/2026
Is your organization leveraging AI to maximize efficiency in safety and regulatory workflows? If not, explore how these technologies are slated to improve industry approaches in 2026.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Scaling Success: A Blueprint For Flexible Biometrics Partnerships2/19/2026
Learn how a micro-FSP model and integrated biometrics team can scale from specialized support to a full-service solution, ensuring agility and consistency as clinical trial needs evolve.
-
Market Approval For A Novel Non-Hodgkin Lymphoma (NHL) Therapy4/11/2025
Explore a collaboration that underscores the importance of strategic planning and regulatory engagement in the approval process.
-
Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research10/6/2025
By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.
-
Reserving Data Integrity With Retrospective Manual Entry7/5/2026
A look at implementing randomization mid-trial by reconstructing subject and inventory records without disrupting sites or compromising data integrity.
-
Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech10/2/2025
This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.
-
Accelerating A Schizophrenia Trial While Ensuring Quality7/31/2026
Tight timelines and rising patient targets don't have to derail a trial. See how speed and data quality can work together from enrollment to database lock.
NEWSLETTER ARCHIVE
- 08.10.26 -- What Sponsors Don't See: The Systems Behind Clinical Trial Delivery
- 08.08.26 -- Clinical Leader Newsletter - Best Of July
- 08.07.26 -- Unify Glucose Monitoring And Enable Passive Abnormal Movement Monitoring
- 08.07.26 -- Upgrade Your Trial Toolkit: Next-Gen eConsent, eSource & AI Platforms
- 08.06.26 -- Development With Orphan Drug Designation And Early Talks With The FDA
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 powered search Engine-GettyImages-2215176753]( "How Visible Is Your Clinical Trial To AI?")
Ross Jacksons explores how clinical trials show up — it at all — in AI tools and what that means for sponsors' approach to publicizing trial information.
-
![Inefficiency, delays, confusion, public administration-GettyImages-2213159033]( "Why Protocol Complexity Is Slowing First Patient In — And How Small Sponsors Can Fix Start-Up Inefficiencies")
Protocol complexity directly affects timelines, costs, and execution quality. Consultant Jessica Cordes explains why this challenge requires sponsors to change their approach to protocol design, feasibility, and start-up.
-
![Busy surgery waiting room-GettyImages-1208597148]( "Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials")
Merck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.
FOCUS ON PATIENTS
-
![Busy surgery waiting room-GettyImages-1208597148]( "Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials")
Merck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.
-
![MRI_forPR_final-(4)-(1)]( "Digital Twins Enhance Disease Progression Measurements In FSHD")
Digital twins can transform trial design by making data more robust and alleviating patient burden. In this interview, Epicrispr CEO Amber Salzman, Ph.D., shares how the company's using it to reliably predict muscle volume change in their trial for a FSHD gene therapy.
-
![kaniel_cassady_01_edit_stairs]( "How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients")
Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.
