If an ICF is not written with the patient in mind — so that it truly facilitates an informed consent — a clinical trial runs the risk of losing viable study participants and derailing study start-up, even success.
- How To Determine Country Feasibility For Cell And Gene Therapy Clinical Trials
- Shorter, Faster, Cheaper: Powerful New Data On Digital Endpoints
- Looking Back & Moving Forward With J&J’s Global Development Leader For Immunology
- Mission: Remission — Patient Need For Durable Treatment Informs J&J’s Ulcerative Colitis Trial
- Ignoring Digital Biomarkers Will Be Your Undoing
- FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions
- ICH E6(R3) And Defining What Is Critical To TMF Quality
GUEST COLUMNISTS
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FDA Warns Industry Of Fraudulent & Unreliable Lab Testing Data In Premarket Submissions
The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.
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2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
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ICH E6(R3) And Defining What Is Critical To TMF Quality
By applying Quality by Design to clinical trials, sponsor companies can rise to meet the elevated role and importance of the TMF in the face of ICH E6 (RF3).
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AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance
The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.
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You’ve Chosen Your Vendor(s), But Have You Thought About Their Oversight?
Vendor management has become an even more complex task involving multiple stakeholders, and it may often be overlooked, especially in the oversight of subcontracted vendors.
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New FDA Draft Guidance: Data Monitoring Committees In Clinical Trials
In a new draft guidance, the FDA describes expectations of data monitoring committees in clinical trials. The public comment period ends April 15, 2024.
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FDA, MHRA, Health Canada Joint GCP Symposium Focuses On 3 Key Topics
The FDA, the U.K. MHRA, and Health Canada recently came together for a symposium on GCP with focus on the ICH E6 harmonized guideline and two other key topics.
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The Results Are In — Survey Reveals Barriers & Opportunities In Site Sustainability
Get a better understanding of site-level dynamics with 2024 release of the Society for Clinical Research Sites' (SCRS) Site Landscape Survey.
CLINICAL TRIAL WHITE PAPERS
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Bringing In Vitro Diagnostics To Market With Real-World Evidence
Explore the potential of real-world evidence in enhancing the regulatory decision-making process to facilitate the market entry of IVDs.
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Patient-Defined Recruitment: The Movement Advanced By COVID-194/17/2024
The pandemic forced the pharmaceutical industry to reimagine how we recruit patients to clinical trials – and it's delivering significant benefits to sponsors who embrace these changes.
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Cell And Gene Therapy Logistics10/27/2023
Take an in-depth look at the obstacles encountered during the Cell and Gene Therapy (CAGT) Logistics asset journey and how to overcome them.
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Robust Models For Supporting PV And Medical Information Activity8/15/2023
Learn how outsourcing local pharmacovigilance and medical information activities to an established safety organization can provide high-quality expertise and technology that meets demand.
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Making Clinical Research Better For Patients With Patient Centricity By Design6/13/2023
Discover why many sponsors struggle to design and conduct studies that accommodate the perspectives and preferences of patients and caregivers.
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Evolution Of Clinical Trials In The Asia Pacific Region9/22/2022
With changing global clinical trials landscape, explore how APAC is emerging as the hot spot for conducting clinical trials, especially in China.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Study Launches Early Phase In Australia With Later Expansion To China5/8/2023
Understand how a biotech company was able to facilitate clinical development plans to extend its study into China for Phase II component, as quickly as possible.
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Rater Training And Central Rating Services Optimize Signal Detection8/8/2023
Explore this comprehensive case study to learn how one sponsor's movement disorder trial was able to optimize signal detection of a primary endpoint using clinician ratings of abnormal, involuntary movements.
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Discngine Advances Life Sciences Research More Securely With OCI12/6/2023
Unearth how this integrated data management on Oracle Cloud Infrastructure (OCI) enabled an R&D firm to build cloud native and low-code apps faster and more efficiently.
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Completing Recruitment In 4 Countries In A Study For ED11/10/2023
Uncover how a leading Eastern European CRO completed patient recruitment ahead of schedule in an erectile dysfunction study involving the evaluation of an innovative MED3000 topical gel.
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Global Phase 3 Study Rescued In Record Time2/28/2023
DSG was selected as the preferred vendor for providing global support and enhanced data quality. Find out how the company was able to dramatically improve database build and study conduct.
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Regulatory Review Of Promotional Materials11/8/2023
Delve into the challenges, objectives, solutions, and achievements of a regulatory review project undertaken by a mid-size pharmaceutical company across the European Union (EU), Asia-Pacific (APAC), Latin America (LATAM), and the Middle East.
NEWSLETTER ARCHIVE
- 04.19.24 -- Strategic Approaches To TMF Management Amidst Workforce Reductions
- 04.18.24 -- You've Chosen Your Vendor(s), But Have You Thought About Their Oversight?
- 04.18.24 -- Your Approach To Managing Complex Clinical Trials
- 04.17.24 -- 4 Questions About A DTx Clinical Trial
- 04.17.24 -- Mobile Nurse Visits Can Transform Clinical Trials - Here's Why
CLINICAL LEADER CONTENT COLLECTIONS
With the advent of decentralized clinical trials and the increased fascination and exploration with technology-assisted processes bringing new data — and more of it — the importance of intentional data collection cannot be overstated. Our latest ebook from Clinical Leader brings you helpful articles on a topic that is arguably the most crucial part of the study process.
More Content CollectionsFOCUS ON PATIENTS
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Digital healthcare and AI technologies play a crucial role in exploring and treating a range of rare diseases as we welcome a new era of personalized care and potentially better patient outcomes.
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Results from the latest CISCRP “Perceptions & Insights” study reveal five opportunities to improve clinical trial recruitment and participation, especially among ethnic and racial minority groups.
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Finding effective treatments for tinnitus has often been circuitous and frustrating for many patients. Tinnitus expert Marc Fagelson, Ph.D., explores the current treatment landscape and what can be done to improve outcomes for patients.
EMBRACING DIVERSITY & INCLUSION
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Clinical trials are essential for evaluating the safety and efficacy of new treatments before they are approved for use by patients. However, a new report from the International Longevity Centre (ILC), in collaboration with RBW Consulting, highlights a significant problem in the clinical trial process: the underrepresentation of older adults.
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The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.
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The enthusiasm for the role of AI in upgrading global health and care provision is justified, provided we understand that the path to success is just as much about communication and collaborative development as it is about the raw potential of the technology itself. Because realizing this technological potential requires us to consider the role of people and processes in an integrated approach.