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With CROs, Decide What You Can Actually Manage

Industry veteran Peter Fredette explores how small biotechs can rethink CRO outsourcing by balancing cost, operational needs, and internal oversight. Before choosing a CRO model, sponsors must honestly assess which services they need — and how many partners they can realistically manage.

GUEST COLUMNISTS

Examining The Potential Of P-tau217 To Provide Earlier Diagnosis Of Alzheimer's
P-tau217 blood tests could accelerate Alzheimer’s diagnosis. Lilly’s Nino Sireci, MD, MSc, explains the research, evidence thus far, potential clinical use, and next steps.
The 50-Page Monitoring Report And The Illusion Of Control
A massive decentralized trial showed why more monitoring doesn’t always mean more control — and how risk-based oversight can reveal what truly matters.
Autoimmune Drugs For Women: What To Bring To The Clinic
Autoimmune disease is one of the most sex-skewed categories in medicine. Sex, reproductive status, and hormonal state should not be treated as background noise.
The Real Cost Of Sites Working Without An Enforceable Agreement: Why Your Site's Quality Of Earnings Is Suspect
Starting site work before an enforceable agreement may look like flexibility, but it can drain leverage, create unrecoverable costs, and raise financial reporting and GCP concerns.
The U.S. Clinical Trial Recruiting Pipeline Report – August 2026
This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from July and August.
How VNS-REHAB Aims To Improve Stroke Recovery After Patients Have Plateaued
Learn how a stroke trial standardized intensive therapy, sustained patient adherence, and exposed access barriers after FDA approval.
Resensitizing Treatment-Resistant Cancer Holds Promise Over Replacing Once-Efficacious Therapies
John Yu, MD, of Kairos Pharma, explains why reversing treatment resistance could extend the life of proven cancer therapies and improve patient outcomes.
Why Oncology Programs Can't Rely On An Inside View Alone
Discover how looking outside a program can help oncology teams test assumptions, improve feasibility, and make stronger development decisions.

CLINICAL TRIAL WHITE PAPERS

Effectively Tailoring Treatments Based On Genetic & Molecular Profiling
Precision medicine is transforming hematology-oncology care by matching treatments to the distinct genetic and molecular profiles of each patient.

10 Clinical Research Practices That Feel Like Compliance (But Aren't)
3/24/2026

Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.
De-Risking The Neurology IND: Lessons From Early FDA Engagement
5/27/2026

Learn how early FDA alignment can help your neurology program move forward with greater clarity, confidence, and regulatory readiness.
A New Era Of ADC Development Demands A New Kind Of Partner
3/30/2026

Explore how to navigate the evolution of antibody-drug conjugates by mastering AI-driven selection, dose optimization, and new regulatory strategies for earlier-line clinical success.
State Of Clinical Trial Technology: The AI Inflection Point
2/12/2026

Digital maturity gaps are widening in clinical research. Connected workflows speed insights and execution, while manual processes leave organizations increasingly behind.
Enhancing Clinical Trial Flexibility
9/1/2025

Once seen primarily as staffing extensions, FSPs have evolved into strategic partners that deliver flexibility, scalability, and tailored expertise.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Transforming Clinical Trial Sites With Research Study Rockstar
2/10/2025

This innovative platform streamlines workflows, automates patient communication, and provides intuitive dashboards to address prevalent pain points faced by trial coordinators.
Improving Clinical Research Efficiency And Access For Underserved Populations
3/26/2026

Modernizing data workflows removes geographic barriers to clinical trials, ensuring rural patients access innovative care while reducing administrative burdens on dedicated research staff.
Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission
1/27/2026

Learn how to create a direct line from clinical planning and protocol design to clinical trial disclosure to optimize efficiency across the entire trial lifecycle.
NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission
8/12/2025

A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).
Supporting Global Approval Of A First-In-Class Gene Therapy For A Rare Genetic Disorder
5/27/2026

Global approvals for a first-in-class gene therapy don’t happen by chance. See how adaptive oversight and inspection readiness kept a complex rare disease program moving forward.
Leveraging A Demand-Led Clinical Supply Model For Program-Level Product Pooling
3/12/2026

See how a global biopharmaceutical company was able to address inefficiencies and reduce waste within the clinical supply chain for a high-value therapy that faced strong demand but limited supply.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

More Newsletters

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.

Most Patients Learn About A Trial Online, But Is That What They Want?

Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.
Why Are We Still Talking About Compensating Research Participants?

Should we be compensating research participants? And is that even a question worth asking? Lindsay McNair, MD, and Ken Getz say yes despite recent data that doesn't point to a clear ROI.
Autoimmune Drugs For Women: What To Bring To The Clinic

Autoimmune disease is one of the most sex-skewed categories in medicine. Sex, reproductive status, and hormonal state should not be treated as background noise.

FOCUS ON PATIENTS

How Plain Language Summaries Created Under EU CTR Can Help Shape NIH Policy

As the NIH shapes its plain language summary policy, EU CTR experience offers practical lessons on clarity, privacy, consistency, and implementation.
Most Patients Learn About A Trial Online, But Is That What They Want?

Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.
Why Are We Still Talking About Compensating Research Participants?

Should we be compensating research participants? And is that even a question worth asking? Lindsay McNair, MD, and Ken Getz say yes despite recent data that doesn't point to a clear ROI.