June 22nd 2023
Study Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.
September 22nd 2022
Clinical trials must rely on internet surveys to incorporate the needs of industry and patients, but how can results be improved?
September 7th 2022
How optimizing RBQM risk detection reduces the efforts caused by false signals.
August 3rd 2022
Survey among readers evaluates the trajectory of RWD and how it can be more widely adopted.
April 22nd 2022
Digital twins, defined as a typical demographic patient profile in a specific population, have the potential to help clinical trial design.
We Can Improve Oncology Trials Using Adaptive Designs
Today’s rich oncology pipeline-accounting for nearly 25% of agents in clinical development-promises much needed advances in cancer therapy.
Overcoming Hematological Oncology Clinical Trial Challenges
Conducting successful clinical trials in hematological malignancies requires an understanding of a rapidly evolving treatment paradigm that is increasingly nuanced, complex and patient-directed.
A Structured Approach to Implementing a Risk-based Monitoring Model for Trial Conduct
An effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
The Future of ePRO Platforms
It is tempting to imagine the use of the patient's own mobile computing platform for collection of patient-reported outcomes (PROs).
The Remote Patient-Centered Study Approach in Clinical Research
In this article, the authors discuss patient-centered research (also termed "direct-to-patient") that uses the "remote" study approach.
Switzerland Guides Innovation in Clinical Trial Regulations
Switzerland is a country small in size, but big in innovation that has always been an attractive location for clinical trials.
Sustaining the Investigator Pool: Understanding Operational Burden and Implementing Valuable Supportive Solutions
The sharp rise in ongoing clinical research studies is driving demand for greater participation in research by physicians as well as by patients.
Integrated Clinical Research Systems: Shortening Development Time by Improving the Efficiency of Clinical Trial Sites
The organization of healthcare is changing rapidly.
Sponsor-Investigator Relationships: A Crisis of Trust in Life Sciences
Timely completion of clinical trials is the weak link in the drug development process, and there is no shortage of suggestions for how to improve it.
Functional Outsourcing in the Pharmaceutical Industry - a Project Management Perspective
It is estimated that by the end of 2014, pharmaceutical companies will lose approximately $78 billion USD as a result of medications going off patent.
Clinical Supply Capabilities, Practices, and Perceptions Among Investigative Sites
Pressure to shorten study start-up timelines puts clinical supply management in the crosshairs.
Efficient Pre-implementation of Multi-site Clinical Trials
Method designed to reduce the time gap between protocol approval and recruitment is examined.
Optimizing Trial Supplies Via Integrated e-Platforms
eGSP-driven approach focuses on overcoming operational challenges through data integration.
Fair Market Conundrum: Solutions for Sponsors & Sites
Breaking through the confusion around fair market value when applying the concept to study budgets.
Decline of Clinical Trials in Central and Eastern Europe: Fluctuation or Trend?
In some countries, the participation in clinical trial, is still the only possibility to be treated.
The Use of a Single Center, Multi-Location Research Structure For Participation in Large Clinical Trials: The Cleveland Clinic Model
As funding for clinical research trials decreases and sponsors of clinical studies are under increasingly stringent timelines to obtain FDA approval and get new therapies to market, the need increases for well-managed, efficient, and effective clinical trial sites.
Enhancing Trial Enrollment Through 'Goal Programming'
How iterative analysis of subject recruitment data can optimize outcomes during ongoing enrollment.
Going Mobile: How Mobile Technology is Evolving in Clinical Trials
It is estimated that mobile penetration now stands at 96% globally.
eGSP: Operational Approach for Optimization of Clinical Trial Supplies Through Integrated e-Platforms
New adaptive study designs, new target diseases, and global studies require on-demand packaging and labeling methods in order to keep operating costs under control.
Lifecycle Modeling and Simulation: Applications in Clinical Development
Computer-based modeling and simulation has advanced numerous industries, from aeronautics and engineering to meteorology and finance.
Fair Market Value Conundrum: Solutions for Sponsors and Sites
Clinical trial budget development continues to frustrate industry sponsors and investigative sites.
Patient-centric Engagement and the Digital Age
The Internet and various services using it as a platform evolve at such a rapid pace that it is difficult to keep track of everything and to understand its significance to clinical trials.
Centralized Statistical Monitoring As a Way to Improve the Quality of Clinical Data
The last decade has seen the complexity, size, and costs of clinical trials increase, which has made the task of guaranteeing data quality progressively difficult.
Method for Efficient Pre-implementation of Multi-site Pharmacological Trials
Increasing the speed with which promising pharmacological treatments move from pre-clinical research to patient-care utilization has received increasing focus in recent years.
High Performing Study Startups
Study startup underperformance and inefficiency has been a problem for executives who manage clinical research trials for decades.
Data Monitoring Committees: Implementation and Sourcing Model Options
Maintaining health and safety of patients is a primary objective when conducting any form of research.
Steps Toward a Successful Clinical Trial Management System
As the importance of translational research continues to grow, research institutions are exploring other options to remain competitive players in the academic clinical research arena.
Time to Change the Clinical Trial Monitoring Paradigm
Results from a Multicenter Clinical Trial Using a Quality by Design Methodology, Risk-Based Monitoring and Real-Time Direct Data Entry
Right Time, Right Channel
Industry news focusing on the people and organizations who work in the clinical trials profession.
The IDEAS Initiative
Improving diversity, education, and advancement in studies: a look at the IDEAS initiative.