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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Unlocking The Potential Of Decentralized Clinical Trials
Explore the current DCT landscape and its evolution, as well as the key advantages of incorporating decentralized attributes and how barriers to their inclusion can be overcome.
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Risks To Sponsors Developing And Running Their Own DCT Technology8/24/2022
Delve into the considerations of inadequate data in DCTs and how a sponsor can ensure it exerts appropriate control over the DCT technologies in place.
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How Biotechs Are Using DCT Technology To Conduct Trials In The APAC Region9/22/2022
In this white paper, gain insight into how the Asia Pacific region, with its rapid growth of clinical trials, presents a great opportunity for conducting clinical research and has become the preferred destination for DCTs.
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4 Ways FSP Models Are Being Used To Drive Success9/11/2023
Dive into several case studies where clients have leveraged clinical research services to surmount critical challenges within the industry and accelerate their achievements.
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Going Global With eConsent4/20/2022
Scott Askin paints the picture of why Novartis, determined to improve the patient experience, has begun to deploy eConsent, and what they’ve learned along the way.
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Cell & Gene Therapy In The Asia Pacific Clinical Trial Landscape1/6/2023
Discover how a new class of therapeutics called cell and gene therapies are revolutionizing how diseases are treated and even potentially cured.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Transforming Invoice And Payment Processes While Reducing Costs1/18/2024
Uncover how Uni Hospital, a state-of-the-art medical center in Bulgaria was able to process invoices and receive payments quicker while noticeably improving accuracy.
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Expert Consulting, MRCT Strategy Rescues Oncology Program5/8/2023
Uncover how teams identified missing IB data and necessary additional details needed to outline U.S. study challenges as required for local authority approval in a previously failing study.
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Expert IND Publishing Support For An Understaffed Regulatory Team5/10/2023
Discover how a clinical-stage biotechnology company was able to successfully file its IND submissions and complete CSR publishing tasks, in addition to creating a synchronized team.
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Patient Engagement: Early Cancer Detection Blood Draw4/17/2024
Discover how we aided a pharmaceutical company in enrolling participants for a Phase III trial, DETECT-ASCEND 2, focused on Plasma-Based CancerSEEK Testing for early cancer detection.
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Consolidating Clinical Supply Chain Operations With GxP Inventory4/18/2024
A Japan-based biotechnology company leveraged Signant SmartSignals® GxP Inventory, which improved visibility, reduced risks and costs, and optimized operations in this case study.
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Top 10 Biopharma Achieves Significant Regulatory Efficiency5/23/2022
Discover how a top 10 biopharmaceutical company expanded its regulatory efficiency and automated key workflows between their IRB Platform and their electronic master file (eTMF).
NEWSLETTER ARCHIVE
- 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
- 04.16.24 -- Improve Site Selection And Identify Your Ideal Patient With AI Insights
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.