The FDA has issued a draft guidance titled Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development and is accepting public comments through October 20, 2025.
- How Brazil's New Law Is Redefining The Country's Clinical Research
- 4 Steps To Make A Business Case For Digital Endpoints
- The Dream Is EHR-To-EDC — eSource Is The Wake-Up Call
- Are Pragmatic Trials The Patient Recruitment Solution We've Been Looking For?
- The New FDA Era Of Radical Transparency And Pervasive Oversight
- Redesigning Oncology Trials Around Tumor Vulnerability: The Rise of WEE1 And DDR Strategies
- Rethinking Clinical Development In The Age Of Synthetic Cell Therapy
GUEST COLUMNISTS
-
Redesigning Oncology Trials Around Tumor Vulnerability: The Rise of WEE1 And DDR Strategies
As clinical progress with DNA damage response (DDR) continues to evolve, research must respond with adaptive models, smarter combinations, and biomarker-informed patient selection.
-
Rethinking Clinical Development In The Age Of Synthetic Cell Therapy
Synthetic biology, especially when applied to engineered stem cells, such as induced mesenchymal stem cells (iMSCs), represents a new frontier. But to get these cells to patients, we need to reimagine how we develop and evaluate them.
-
How Digital Twins Are Rewriting Clinical Trials
While the benefits of digital twins to accelerate clinical trials are undeniable, many questions about their use are still unanswered and go far beyond technology.
-
3 Quick Takes From A PI With 100+ Trials To His Name
Principal investigator Norman B. Gaylis, MD, shares his perspective on patient recruitment, protocol design, and vendor selection.
-
Alzheimer's Trial Targeting Amyloid Beta Oligomers Sees Cost Savings, Patient Satisfaction With New Screening
Acumen Pharmaceuticals' Eric Siemers, MD, discusses their novel Alzheimer's disease screening method and trial design for investigational drug sabirnetug that keeps both the clinical site and patient experience in mind.
-
Insuring Global Clinical Trials: Navigating Risks Across Borders
Foreign clinical trials insurance is indispensable. Learn its features, its benefits, and why it's needed.
-
Misconceptions About Cancer Clinical Trials And How To Overcome Them
Medical oncologist Wasif Saif, MD, MBBS, discusses many of the misconceptions held by patients and clinicians about cancer clinical trials.
-
RWE Is Not Optional, It's Essential
UCB Head of Medical Strategy, Bone Health, Jennifer Timoshanko explains why RWE is a valuable alternative to RCTs and shares best practices for collecting it.
CLINICAL TRIAL WHITE PAPERS
-
Master Protocols: Implementing Effective Treatment Adaptations
From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions with minimal disruption.
-
Reimagining Medical Monitoring In Clinical Research4/11/2025
Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
-
IPF - Global Clinical Trial Landscape5/19/2025
This report provides a comprehensive overview of Idiopathic Pulmonary Fibrosis (IPF), a progressive and fatal interstitial lung disease.
-
Cystic Fibrosis: Global Clinical Trial Landscape (2024)4/8/2024
Gain valuable insights on patient enrollment, site selection, and navigating global regulatory landscapes tailored to rare diseases, thus propelling forward CF research and treatment.
-
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.
-
Non-Small Cell Lung Cancer — Global Clinical Trial Landscape (2024)7/3/2024
Explore cutting-edge Non-Small Cell Lung Cancer (NSCLC) research with Novotech CRO's in-depth disease analysis, providing insights into innovative therapies, clinical trials, and future directions shaping NSCLC care globally.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Regulatory Portfolio Management: From Bad To Gold10/30/2023
Uncover how a multiphased approach helped a small biotech to organize its programs so that it could efficiently make decisions, timely adapt to changes in strategy, and better understand current activities.
-
Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions12/8/2023
Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.
-
Educating Globally Diverse Populations Through Branding & Visuals10/31/2024
See how this customized educational approach significantly enhanced recruitment and retention efforts, helping to ensure a more inclusive trial for Nonobstructive Hypertrophic Cardiomyopathy (nHCM).
-
CRO Leverages Integrated Central IBC Partnership To Initiate Sites5/15/2024
Learn how a CRO was able to accelerate review times so COVID-19 vaccine trial sites could progress through site selection, IRB/IBC submission, approval, drug shipment, and complete site initiation visits in record time.
-
Recruiting & Retaining More Patients Per Site:3/14/2025
Through Home Trial Support (HTS) services, MRN is able to enhance the accessibility of clinical trials while reducing the emotional toll on their patients suffering from loss of mobility.
-
Mobile App And Wearable Integration Collects Longitudinal Data2/12/2024
Get an overview of SISCAPA's utilization of eTechnologies, specifically ePRO, and how their partnership with CDS accurately demonstrates the improvement of data collection and analysis in the biotechnology industry.
NEWSLETTER ARCHIVE
- 09.17.25 -- Social Media And A Site-Less Model Lead To Pandemic-Era Success
- 09.17.25 -- STREAM Edition: Australia's R&D Incentive: Not A Gift, But A Tax Strategy
- 09.16.25 -- AI-Enhanced Clinical Project Management For Cell And Gene Therapy Clinical Trials
- 09.16.25 -- Strengthen Protocol Certainty
- 09.15.25 -- More Personalized, Precision Medicine Needed In Psychiatry 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.
-
CISCRP shares its mobile education project brings clinical trial awareness and information directly to communities.
-
Principal investigator Norman B. Gaylis, MD, shares his perspective on patient recruitment, protocol design, and vendor selection.
-
Medical oncologist Wasif Saif, MD, MBBS, discusses many of the misconceptions held by patients and clinicians about cancer clinical trials.
FOCUS ON PATIENTS
-
CISCRP shares its mobile education project brings clinical trial awareness and information directly to communities.
-
Brazil aims to revamp its clinical research industry with the introduction of a new law intended to make trials faster, empower local ethics committees, and give patients greater post-trial access to investigational drugs.
-
TransCelerate's Rob DiCicco reintroduces the "pragmatic trial" design concept, discusses its potential benefits, and provides resources for its integration.