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.
- Reducing The Number Of Clinical Holds On Cell And Gene Therapies: Approaches For Sponsors And The FDA
- The Rise, Fall, And Eventual Rebound Of DCTs
- Fine-tuning Analytical Development Strategies For Every Phase
- AI Technologies Drive Drug Development And Enhance Patient Experience In Neurology & Rare Diseases
- No CRO? No Problem As Curadev Tackles Site Selection For Its First Clinical Trial
- Latest CISCRP Patient Survey Reveals Diversity Gaps, Yields 5 Tips For Improvement
- Why Small Clinical-Stage Companies Need Developmental Risk Management Plans
GUEST COLUMNISTS
-
Latest CISCRP Patient Survey Reveals Diversity Gaps, Yields 5 Tips For Improvement
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.
-
Why Small Clinical-Stage Companies Need Developmental Risk Management Plans
For small clinical-stage companies, developmental risk management plans are not a regulatory requirement but a strategic imperative to proactively manage risks.
-
Why The ‘Illusion’ Of Speed In Clinical Trials Unravels As Contracting Demands Scale
Discover four mistakes biotechs often make in haste (and how to avoid them) as they hurry through clinical trial contracting on the path to commercilization.
-
Informed Consent In Clinical Trials: Understanding The FDA’s And OHRP’s Joint Draft Guidance
The FDA and OHRP have jointly issued a new draft guidance about how sponsors, investigators, and IRBs should structure and present informed consent documents to clinical research participants.
-
What’s Needed To Keep Tinnitus Research From Going Quiet
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.
-
Could Consolidating Independent Sites Into Site Networks Be The Research Revolution We Need?
The formation of clinical trial site networks appears to be rising in popularity. Understand how these integrated networks can contribute to more effective, patient-centric trials — if done correctly.
-
A Better Recipe For Sourcing Your Clinical Trial
Is outsourcing still the optimal pathway for conducting clinical trials in the 21st century? A better recipe for success might include insourcing and functional service providers (FSP), sprinkled with a handful of outsourced tasks, for a more stress-free and agile clinical trial experience.
-
A Structured Approach To Regulatory Information Management Vendor Selection
Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.
CLINICAL TRIAL WHITE PAPERS
-
The Shifting Paradigm Of Dose Selection In Oncology
Oncology drug development is undergoing a significant transformation. Explore strategies for integrating dose finding and optimization into early clinical development and how it could benefit oncology patients.
-
Top Therapeutic Areas In The Asia Pacific Clinical Trial Landscape1/6/2023
Explore why the Asia-Pacific region has emerged as a clinical trial hub due to the ease of regulatory compliance, low trial costs, rising patient population, and the availability of top clinical institutions as trial locations
-
How eConsent Is Changing The Informed Consent Process5/26/2022
Learn how informed consent — providing a potential participant with enough information about a study to allow for an informed decision about their participation — is a critical step for enrolling patients in clinical trials.
-
Direct-From-Patient Data Capture With eCOA5/2/2022
Learn how an eCOA tool can provide patients a chance to be heard while giving sponsors quantitative and qualitative data to track the efficacy of a treatment.
-
The Rise Of Decentralized Clinical Trials3/29/2022
Discover how technological advancements have created the Internet of Things (IoT), in which numerous devices, including wearables like fitness trackers, can all be connected through software and cloud computing.
-
Beyond Integration: Flexible Orchestration Of IRT And eCOA Solutions4/25/2023
Consider how integrated response technologies and electronic clinical outcomes assessments can improve configurability, study start-up, and flexible mid-study changes.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
DCT: Book Of Case Studies10/18/2023
Review this collection of case studies showcasing Medidata's capabilities in decentralized trials, including the industry's first fully decentralized megatrial, ADAPTABLE.
-
Maximizing Efficiency In Data Management Services In A Breast Cancer Study1/13/2023
Learn how database validation, database lock, and the development of the electronic CRF were used in a HER2-positive operable breast cancer study.
-
Alliance Bolsters Patient Engagement And Data Insights9/19/2023
Learn how the Metastatic Breast Cancer Alliance’s desire for richer participant information and heightened patient engagement led them to create MBC Connect™.
-
How NetSuite And Coupa Integration Helps Biotech Companies Streamline Processes And Manage Growth1/30/2023
Discover how a therapeutics company began the search for a business spend management solution that would automate everything from procurement to payments and integrate seamlessly with a new ERP.
-
RTSM Manages Clinical IP Dispensation In Schizophrenia Study8/30/2023
Challenged by the dispensation of an investigational product (IP) across diverse patient subgroups, see what solution this pharma was able to utilize to ensure optimal distribution and minimize wastage.
-
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
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
-
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.
-
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.
-
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
-
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.
-
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.
-
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.