Just In Time GCP Founder and CEO Donna Dorozinsky contemplates some of the developing uses of generative AI for inspection readiness.
- Top 4 Trends For Neuropsychiatric Disease Research In 2025
- A Data-Driven Approach That Could Change Mental Healthcare In 2025… And Beyond
- Seeing Firsthand The Transformative Impact Of AI On Pharmacovigilance And Clinical Research
- 2024: Familiar Problems & Encouraging Progress
- Site Capabilities — The Hidden Drivers Of Clinical Trial Success
- Here's A Template — And Tips — For Assessing And Improving Patient Centricity
- Can Better Data Management Save Clinical Trials?
GUEST COLUMNISTS
-
Patient Weighs Altruism, Self-Preservation, And Historical Mistrust In Decision To Enroll In Trial
In part three of this series on underserved patient enrollment, patient advocate Bill Allen shares why he enrolled in a clinical trial for both himself and the Black community.
-
Enrollment Mishap Emboldens Patient To Advocate For Minority Participation
In part two of this series on underserved patient enrollment, PAN Foundation patient advocate Tony Newberne shares how narrowly missed trial enrollment and how the experience inspired him to advocate for clinical research in minority communities.
-
The PAN Foundation Expands Resources For Underserved Patient Populations
In part one of this series on underserved patient enrollment, PAN Foundation CMO Amy Niles discusses the Foundation's efforts to improve access to and affordable healthcare for (including in clinical research) underserved patient populations.
-
UCB Emphasizes Importance Of Patient-Centric Protocols
UCB Global Medical Head of Immunology John Ioannou emphasizes the need to partner with the healthcare community, supporting medical and patient organizations, but most importantly, patients to advance the design and execution of patient-centric clinical trials.
-
How Changes To The Declaration Of Helsinki Impact Clinical Trials
Consultant Jessica Cordes breaks down the latest version of the Declaration of Helsinki and how it builds upon the previous version from 2013.
-
Scaling Gene Therapy Clinical Trials Through The Lens Of Ophthalmology
Ocugen CMO Huma Qamar, MD, MPH, CMI discusses scaling gene therapy clinical trials with special attention paid to logistical planning, collaboration with specialized centers, and managing future manufacturing needs.
-
The One-And-Done Investigator: A Clinical Trial Story
There are too many one-and-done principal investigators in clinical research — at least that's the common refrain. But Paul Ivsin isn't convinced. Here, Ivsin looks into and discusses the supposed one-and-done PI crisis.
-
CRO Summit Chair Muses On The Future Of CROs
Clinical Outsourcing Group CRO Summit Chair and seasoned biopharma CxO Jasmina Jankicevic shares her insights on the evolving landscape of CROs.
CLINICAL TRIAL WHITE PAPERS
-
The Current And Future Landscape In Respiratory Connected Devices
Gain insight into the dynamic technological revolution unfolding in respiratory function testing, particularly within wearable connected devices.
-
Rare And Orphan Diseases: Choosing A Path To Regulatory Approval And Market Success1/17/2023
Learn about the challenges of bringing rare disease drugs to market within the U.S. system and some of the guidance for sponsors on meeting them.
-
Optimizing Generative AI In Clinical Operations4/17/2024
Crafting a thoughtful strategy to determine the optimal utilization of Generative AI in advancing medical research and enhancing patient well-being.
-
CRISPR And The Commercialization Of Gene-Based Therapies8/27/2024
The importance of early collaboration between drug developers, manufacturers, and payers is becoming more evident, as it aids in the creation of meaningful clinical endpoints and the formulation of a viable market access strategy.
-
How Clinical Trial Design Impacts Enrollment Of Diverse Populations4/17/2024
Discover the latest findings revealing crucial insights into the factors influencing participants' engagement in clinical trials, offering valuable knowledge about the diverse perspectives and considerations driving participation decisions.
-
Navigating The Biotech Landscape Amidst Covid-19 And Beyond11/7/2023
Access comprehensive insights and analysis for a deeper understanding of the biotech landscape, including optimism and challenges felt throughout 2023 and what the future could hold.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
A Sponsor's Commitment Drives Global Site Adoption & Process Optimization2/15/2023
A global top 10 pharma sponsor needed a provider whose core focus was on patient payments with heightened functionality and centrality. Find out the solution they turned to to solve this need.
-
Medicenna Gains Precedent-Setting FDA Approval12/8/2022
Learn how Medicenna was able to leverage Synthetic Control Arm (SCA) to bolster Phase 2 findings and gain FDA approval to design a hybrid external control arm for their Phase 3 registrational trial.
-
Linking RWD And Patient Insights To Help Demonstrate Asset Value8/22/2024
Real-world data (RWD) in clinical research often lacks detail on patients' personal characteristics and treatment experiences. In this example, our team leveraged innovative data science techniques to bridge the gap.
-
Zero Disruptions: Migrating 14 Mid-Study Clinical Trials In 16 Months11/15/2023
Uncover how Imperial College London was able to effectively transfer 14 ongoing studies, encompassing over 1,700 patients and 150,000+ forms, onto a new EDC platform within 16 months.
-
Improving Patient Health And Safety7/25/2024
Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.
-
Improving The Advanced Therapies Digital Landscape6/3/2024
Discover how ProPharma transformed a rapidly growing biotech company's data governance and systems architecture to enhance efficiency and data integrity.
NEWSLETTER ARCHIVE
- 12.05.24 -- Mental Health Apps: Regulation And Validation Are Needed
- 12.05.24 -- Global Overview Of Cancer Clinical Trials
- 12.04.24 -- Defying Industry Setbacks, MindMed Advances Psychedelic To Phase 3
- 12.04.24 -- STREAM Edition: 5 Strategies To Dramatically Improve Clinical Data Quality
- 12.04.24 -- Transform Your Clinical Trials With Expert eCOA And eConsent Insights
CONTENT COLLECTIONS
FOCUS ON PATIENTS
-
Four program directors from the Medical Device Innovation Consortium (MDIC) share their predictions on the trends that will drive innovation and reshape clinical research in 2025.
-
The Crohn’s & Colitis Foundation shares its guide to reviewing current patient engagement activities and plans for a more patient-centric future.
-
In part three of this series on underserved patient enrollment, patient advocate Bill Allen shares why he enrolled in a clinical trial for both himself and the Black community.
RECRUITMENT AND DIVERSITY
-
Consultants Aashna Goyal and Guriqbal Singh share first-persona accounts of how AI is transforming pharmacovigilance and clinical research by improving data processing, enhancing decision-making, and accelerating drug development.
-
In part three of this series on underserved patient enrollment, patient advocate Bill Allen shares why he enrolled in a clinical trial for both himself and the Black community.
-
In part two of this series on underserved patient enrollment, PAN Foundation patient advocate Tony Newberne shares how narrowly missed trial enrollment and how the experience inspired him to advocate for clinical research in minority communities.