Authors
Latest:
The Remote Patient-Centered Approach in Clinical ResearchIn the healthcare arena, the concept of patient-centeredness has expanded over the last 50 years, beginning as a term to describe patient engagement in self-health management and evolving to include various aspects of patient engagement in healthcare research.1
Latest:
Risking it All? Going All in on RBM AdoptionCancer Research UK (CRUK) followed such advice when it decided to have its Center for Drug Development (CDD) adopt a risk-based monitoring (RBM) approach across its entire portfolio of clinical trials.
Latest:
Placebo Effect of Transdermal NSAIDSThe implications and challenges of the placebo effect on regulatory agency product approval.
Latest:
Manage Trial Master Files via Investigative PortalsAutomated eTMF solutions reduce costs, improve productivity, and enhance data management.
Latest:
Demystifying Asian TrialsConducting clinical research in the East brings a new group of challenges to sponsors
Latest:
Personalized Medicine DevelopmentAs the popularity of personalized medicine grows the role of the CRO continues to evolve.
Latest:
Late Phase Study TrendsThis recent report explores key factors behind customer satisfaction and other dynamics within the Late Phase market.
Latest:
Pediatric Consent ErrorsThe intent of consent is that participants are comfortable with their choice and can comply with it.
Latest:
The FDA's Guidance on PROThis guidance has both raised the stakes and improved the odds of securing label claims based on PROs.
Latest:
Archiving Approach in the UKThe proper storage of research documents remains an essential aspect of the clinical trials process.
Latest:
The Role of Observational Research & Patient Registries in Evidence GenerationThis whitepaper discusses the importance of observational research and patient registries in evidence generation. The modern healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes. These often conflicting perspectives require access to a portfolio of interventional and observational research designs sub-serving different objectives … Increasingly central is the inclusion of observational studies, including registries, which provide insights missing from traditional nterventional studies encountered in the course of drug development.
Latest:
A Structured Approach to Implementing a Risk-based Monitoring Model for Trial ConductAn effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
Latest:
A Structured Approach to Implementing a Risk-based Monitoring Model for Trial ConductAn effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
Latest:
A Structured Approach to Implementing a Risk-based Monitoring Model for Trial ConductAn effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
Latest:
A Structured Approach to Implementing a Risk-based Monitoring Model for Trial ConductAn effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
Latest:
A Structured Approach to Implementing a Risk-based Monitoring Model for Trial ConductAn effective risk mitigation model requires the development of a structured approach to risk identification, analysis and control, from trial inception to completion.
Latest:
Predictions for 2015: Trends in Clinical Trial ProcessesIt’s clear that the value clinical trials bring to the health and well being of our existence is being recognized and expectations from the public are high.
Latest:
Transforming Cognitive Health Conditions through Clinical GamesAs clinical games emerge as a new tool for diagnosing and treating cognitive health, it is important to understand how these tools work and the ways in which these tools are validated, as well as how to realize their full potential.
Latest:
The Employee Profile in China Pharma R&DIn this analysis, distinctions between who hires who in non-Chinese and China-based companies emerges.
Latest:
Keys to a Successful Study Start-up Transformation - Best Practices from Top 20 PharmasAutomating study start-up in a single application enables faster site activation, better collaboration with study partners, and more informed decision-making. Read this white paper to learn best practices from top 20 pharmas on effective study start-up deployment and how to overcome common barriers to change.
Latest:
Steps for a Successful Clinical Trial Management SystemAs the importance of translational research continues to grow, research institutions are exploring other options to remain competitive players in the academic clinical research arena.
Latest:
Positive Changes for Clinical Trials in UkraineThe Ukrainian Government has implemented several important measures to make the country more attractive for clinical trials.
Latest:
The Impact of Faster Drug Approvals on Oncology Clinical Trial DesignDue to a shifting landscape because of faster drug approvals, this article offers strategies for sponsors to design clinical trials.
Latest:
Using Compliance Data for Strategic AdvantageHelp desk centers offer sponsors the chance to mine valuable PV data.
Latest:
Big Data is Built From Tiny FragmentsDo patients really want to share their data? Nearly half of the rare disease patients responding to an international survey, are against their data being shared outside or even within the medical field.
Latest:
Designing Alzheimer’s Disease Clinical Trials For SuccessAlzheimer’s disease (AD) is and will remain one of the most unyielding public health crises of the 21st century. Aging global populations translate to a constantly growing prevalence of a disease with no cure and an immense cost of care. In the United States alone, recent estimates1 suggest that 28 million people will develop AD by midcentury. Approximately 25% of the annual Medicare budget will be spent treating the disease – a projected $330B in 2040 – with hundreds of billions more in indirect costs.
