Clinical Leader - Helping clinical research professionals connect and collaborate

Collaboration Isn't Sexy. That's Kind of the Point.

SCRS’s Collaborate Forward playbook isn’t about reinventing clinical trials; it’s about fixing how people work together. Based on real-world examples, the initiative shows how small, practical changes in collaboration are already improving study startup, site relationships, and operational performance.

GUEST COLUMNISTS

ALS Researchers Use Stratification, Diverse Endpoints To Address Heterogeneity
Coya Therapeutics' Fred Grossman dives into innovative trial design elements and a novel biomarker that might better account for clinical and functional progression in Coya's ALS trial studying a dual immunomodulatory therapy.
Clinical Failures Persist Because They're Structural, Not Random
Clinical failures are no longer contained within a single program but happen across portfolios, companies, and therapeutic areas. Advisor Mikail Evteev suggests the reason is a failure to learn from past mistakes.
Human-In-The-Loop In AI Validation And Control: From Principle To Practice
Explores how human-in-the-loop oversight can move from principle to practice. with a risk-based framework for determining when HITL is required, how the human role should be defined, and what organizational factors influence its effectiveness.
Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support
Fixed patient reimbursement isn't enough, says Donna Libretti Cooke, Erin Miller, and Jeanne M. Regnante. To truly care for patients and support their participation in a clinical trial, they need whole-person support.
Breaking Barriers In Rare Disease Clinical Trials
Priovant Therapeutics CEO Ben Zimmer shares lessons learned from rare disease VALOR trial exploring a new therapy for the treatment of dermatomyositis.
Reimagining Data Governance For The AI Era
Understand the persistent governance challenges that undermine AI initiatives and walk away with a robust blueprint for building a resilient, scalable, and ethically sound framework.
Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials
Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today.
Philanthropy Empowers And Accelerates Testing Of Drug Combinations In T1D
City of Hope’s Alberto Pugliese, MD, discusses how philanthropic gifts helped launch a landmark multi-center trial to test a combination therapy using repurposed drugs for the treatment of Type 1 Diabetes.

CLINICAL TRIAL WHITE PAPERS

Writing An IND Module 3 For Cell And Gene Therapy Products
This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

How Sponsors Can Drive Success With Central eSource At Investigator Sites
6/17/2025

Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.
Overcoming Challenges In Obesity Trials
2/12/2026

Obesity trials face high dropout rates due to long durations and complex requirements. Overcome these hurdles with personalized engagement, expert lifestyle support, and proactive patient care.
Challenges And New Approaches To Developing Clinical Evidence For Medical Devices
9/12/2024

Learn about the challenges and new approaches to developing clinical evidence for medical devices, including decentralized trials, adaptive studies, in silico trials, and real-world evidence.
Understanding Immunogenicity In AAV Gene Therapy
8/14/2025

As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.
Rewriting The Future Of Clinical Trials
8/8/2025

In an increasingly data-complex environment, eCOA is emerging as a foundational pillar for both operational agility and scientific rigor in clinical development

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Solutions To The Challenges Of Oncology Trials
5/6/2025

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.
Biotech Delivers A Superior Patient And Site Experience
3/4/2025

To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.
Sol-Gel Builds Awareness Of Rare Skin Condition, Generates Leads
4/1/2026

Explore a 60-day HCP Awareness email campaign that surpassed industry benchmarks and generated a substantial number of leads.
Early-Stage Development In Rare Pediatric Oncology
4/11/2025

Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.
Accelerating A Global, FIH ADC Therapy Trial For Lung Cancer
11/17/2025

Choose a development partner who can navigate global execution, ADC-specific challenges, and Project Optimus requirements so your first-in-human study is designed and positioned for success.
Overcoming Participant Compliance Challenges In A Medical Device Study
9/9/2024

Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.

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.

Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support

Fixed patient reimbursement isn't enough, says Donna Libretti Cooke, Erin Miller, and Jeanne M. Regnante. To truly care for patients and support their participation in a clinical trial, they need whole-person support.
Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials

Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today.
Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)

In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.

FOCUS ON PATIENTS

Precision Medicine Needs Better Infrastructure — And We Already Have The Models For It

Standard methods for evaluating clinical trial representativeness perform poorly when the trial population differs from the broader disease population in a patient registry. June Cha, Ph.D., MPH, explains how the right metrics can make a difference.
Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support

Fixed patient reimbursement isn't enough, says Donna Libretti Cooke, Erin Miller, and Jeanne M. Regnante. To truly care for patients and support their participation in a clinical trial, they need whole-person support.
Breaking Barriers In Rare Disease Clinical Trials

Priovant Therapeutics CEO Ben Zimmer shares lessons learned from rare disease VALOR trial exploring a new therapy for the treatment of dermatomyositis.