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One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial Execution

Having the same number of clinical programs as team members might sound crazy, but for Step Pharma, it has become one of their biggest strengths.

Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDA
The Compliance Problem With Excel Trackers And Other Computational Tools — And How AI Can Help

GUEST COLUMNISTS

How The Quiet Data Standards Revolution Is Impacting Drug Approval
Principal Statistical Programmer Varun Debbeti details the role data standards play in approval timelines, detailing shortfalls of current the model and CORE, Dataset-JSON, and SDTM v3.0 stand to make an impact.
Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial Hypertension
Cereno Scientific’s Rahul Agrawal discusses the scientific and strategic rationale behind extending the company’s Phase 2b study duration and how the company incorporated regulator and patient input.
What's Wrong With Site Benchmarking? A Site-Centered Perspective On Its Alignment, Transparency, And Use
Benchmarking is widely used and highly valued, yet trust in it is limited. The League Benchmarking Working Group has set out to standardize how site metrics are defined, contextualized, and applied.
New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA
NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.
The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn't It?
Strep A kills around 500,000 people each year, and a vaccine would change this and is within reach. Yet, no strep A vaccine is currently in Phase 3. 1Day Sooner's Josh Morrison explains why and shares how FDA could make Strep A vaccines a reality.
How Acquiring Sponsors Can Keep Post-Acquisition Clinical Operations Running Smoothly
When acquiring another company, the acquiring sponsor must preserve operational continuity across active trials while integrating new assets, teams, technologies, vendors, and decision structures. Leila Cupersmith explains how.
5 Signals Teams Should Track To Avoid Clinical Trial Execution Drift
Many teams detect execution drift too late. To stay head, learn how to follow these five governance signals: documentation reliability, ownership clarity, dependency visibility, escalation discipline, and decision-ready review quality.
Lessons In Pivoting From A Clinical Trial Launch In Uganda
Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.

CLINICAL TRIAL WHITE PAPERS

Challenges And New Approaches To Developing Clinical Evidence For Medical Devices
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.

AI in Pharma: Benefits, Risks, And The Road Ahead
10/23/2024

How could leveraging AI technologies, including machine learning (ML) and generative AI (GenAI), enable your company to streamline processes from drug discovery to post-launch?
Routes To Sponsor Of Choice: Shared Pipelines, Streamlined Payments
10/30/2024

Paying clinical trial sites consistently on time provides stability and maintains positive relationships. Learn why being a sponsor of choice can mean the adoption of a singular clinical trial payments solution.
Decentralized And Community-Based Solutions Driving Women's Healthcare
9/24/2025

Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
Improving The eCOA Experience
1/25/2026

Discover how template-driven builds and reuse can slash eCOA timelines by 50% while solving the licensing and translation hurdles that delay First Patient In.
The Patient Recruitment Shift: Navigating Disruption, Delivering Precision
3/27/2025

Explore the four macro trends reshaping the recruitment space in 2025—each grounded in emerging data, technology, and behavior shifts.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Pioneering The End-To-End Decentralized Trial Experience
4/16/2025

This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
Advancing Dose Escalation Strategies With Bayesian Modeling
8/12/2025

A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.
Optimized Processes: A Guide To Lyophilization Cycle Development
6/25/2024

Review the essential phases of the lyophilization cycle — freezing, primary drying, and secondary drying — and critical success factors to achieve optimal product quality and stability.
Outgrowing Excel: Implementing RTSM Software In A Live Phase I Trial
3/26/2026

Moving from manual spreadsheets to RTSM mid-study requires precision. Learn how clinical teams maintain trial momentum while executing protocol changes without delays.
Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research
10/6/2025

By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.
How Syneos Health Tackles Protocol Complexities
1/7/2025

Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase I-IV clinical trials, particularly under a complex adaptive trial protocol.

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.

Lessons In Pivoting From A Clinical Trial Launch In Uganda

Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.
Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community

CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.
Taking On Patient Recruitment From Another Angle — The Payer

Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment.

FOCUS ON PATIENTS

A Blueprint For Addressing Underserved Patient Populations

Does our current approach to clinical research truly serve the patients who face the greatest needs? Insmed Inc. CMO Martina Flammer, MD, MBA, explores how to better meet patient needs.
New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA

NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.
Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community

CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.