Discover how resources from the Medical Device Innovation Consortium (MDIC) can help advance clinical trials for better patient outcomes.
- How PDS Biotech Approached FDA Meetings For Its Phase 3 Cancer Trial
- FDA Finalizes Guidance On The Advanced Manufacturing Technologies Designation Program
- Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars
- Input Needed On Using AI To Create Lay Summaries Of Trial Results
- The Scoop On SCOPE
- Annual SCOPE Summit Serves Up A Similar But Satisfying Menu
- How "Atomic Habits" Can Help Optimize Patient Recruitment
GUEST COLUMNISTS
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How "Atomic Habits" Can Help Optimize Patient Recruitment
With the third article in his series “Inspired Patient Recruitment — Taking Inspiration from Business Advice Bestsellers," Ross Jackson applies theories from "Atomic Habits" by James Clear to clinical trial patient recruitment.
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A Tool To Tackle The Risk Of Uninformative Trials
Uninformative trials hinder progress in clinical practice, policy decisions, and further research. Fast Data Science developed a free risk tool to help pharma companies avoid them.
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In Clinical Research, Every Day Is Groundhog Day
Rather than proffer some New Year's predictions, Paul Ivsin looks at clinical research through the lens of Groundhog Day and the tradition of reinventing the same thing over and over again.
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Biopharma R&D Faces Productivity And Attrition Challenges In 2025
Evaluate VP of Thought Leadership Daniel Chancellor discusses trends for 2025 as the surge in R&D, coupled with rapidly evolving industry dynamics, presents a productivity and attrition challenge for the industry.
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FDA Issues Draft Guidance: Study Of Sex Differences In The Clinical Evaluation Of Medical Products
The U.S. FDA's recent draft guidance on the Study of Sex Differences in the Clinical Evaluation of Medical Products deduces that individuals whose sex is assigned as “female” at birth are underrepresented in clinical trials. The public comment period ends April 7 (in theory), though it should be noted that the guidance was removed from the FDA website shortly after the new administration took office.
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Tech Vendors Are Today's Don Quixotes
Don Quixote is known for tilting at windmills, believing them to be enemies. Today, it seems, emerging tech solution developers are embodying the spirit of the quixotic knight centuries later.
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FDA Provides Updated Draft Guidance To Support E6(R3)
Get a quick but thorough understanding of the latest guidance updates with this summary of "E6(R3) Good Clinical Practice: Annex 2."
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What Is "Patient-Centric" About A Clinical Trial?
"Patient-centric" has been a characteristic most sponsors, CROs, and sites have endeavored to achieve in describing clinical trials. But what does the term "patient centricity" actually imply?
CLINICAL TRIAL WHITE PAPERS
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Patient Diversity: Identifying Challenges, Opportunities, And Best Practices
By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.
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HIV – Global Clinical Trial Landscape1/3/2024
Get a comprehensive overview of the global HIV clinical trial landscape since 2018, showcasing regional leadership, trial phases, and growth rates.
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Improving Diversity Data In Clinical Trial Benchmarking & Feasibility6/15/2023
Improving diversity representation in clinical trials relies on demographic data. Get a glimpse of the problems sponsors encounter when obtaining this data and how regulatory agencies are working to ensure its accessibility.
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Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change3/9/2023
A strong labeling team is vital to ensure successful navigation of the legal entity change process, including developing a timeline, executing data transfers, and mitigating compliance risks.
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Closing The Gap In Our Understanding Of Sleep Health With DHTs4/26/2024
This article delves into the current state of sleep assessments in clinical trials, advocates for a broader understanding of sleep, explores opportunities presented by wearable digital health technologies and examines regulatory expectations.
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Site Satisfaction: Influencing Tech Development Strategies4/19/2023
Technology is playing an increasingly important role in clinical trials, helping to improve efficiency, compliance, and data quality. Learn why it’s critical that clinical study technologies are easy to use across sites and fit into the team’s workflows.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Validating New Identification Algorithms With Objective Criteria & Clinical Trial Data7/19/2023
Learn how researchers and clinicians can make better-informed decisions to advance patient care and enhance public health outcomes related to myocardial infarction.
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Breaking Free From Process Paralysis In Clinical Trials1/13/2025
Explore the implementation of CRIO’s eSource solution by a leading pharmaceutical company to overcome process paralysis in clinical research.
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RTSM And Clinical Drug Dispensation7/16/2024
A pharma company used Signant Health's RTSM solution in a Phase 2 schizophrenia trial to ensure drug availability, maintain study balance, prevent duplicate allocations, and manage returns and destruction of unused drugs.
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Fast Data Insights Improve Productivity, Client Centricity7/20/2023
Discover how Medidata's Rave CTMS seamlessly met the comprehensive requirements of Catalyst Clinical Research—an exclusive CRO provider specializing in oncology—during a period of rapid expansion.
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How Optina Diagnostics Used EDC In Earlier Disease Detection5/15/2024
Understand how Optina Diagnostics streamlined operations and achieved significant milestones by leveraging Castor's tools in its effort to revolutionize the diagnostic process for Alzheimer’s.
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From Phase I In Australia To A Global Phase III5/8/2023
With some help, see how one California-based biotech company was able to get its patients on treatment by the end of the fiscal year and identify additional opportunities to streamline processes and leverage document/process standards.
NEWSLETTER ARCHIVE

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.
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Executive editor Abby Proch sums up her second SCOPE Summit experience.
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With the third article in his series “Inspired Patient Recruitment — Taking Inspiration from Business Advice Bestsellers," Ross Jackson applies theories from "Atomic Habits" by James Clear to clinical trial patient recruitment.
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The U.S. FDA's recent draft guidance on the Study of Sex Differences in the Clinical Evaluation of Medical Products deduces that individuals whose sex is assigned as “female” at birth are underrepresented in clinical trials. The public comment period ends April 7 (in theory), though it should be noted that the guidance was removed from the FDA website shortly after the new administration took office.
FOCUS ON PATIENTS
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"Patient-centric" has been a characteristic most sponsors, CROs, and sites have endeavored to achieve in describing clinical trials. But what does the term "patient centricity" actually imply?
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Medical director and clinical lead Jason T. Lerner, MD discusses Biohaven's patient-centric approach to its pediatric epilepsy clinical trials, from reducing visit frequency to offering virtual visits and more.
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Learn what makes someone "underserved," understand the importance of that person's participation in research, learn about the barriers to them doing so, and discover ways to improve their inclusion.