Without question, advanced cellular and gene therapies require well-defined cold-chain management solutions that reduce risk and include all elements of packaging, data collection and logistics expertise to ensure high-quality, effective treatments reach the point of care, and ultimately, the patient.
Planning for ethnic sensitivity from a scientific and regulatory perspective.
The industry is experiencing a paradigm shift from pharmacovigilance rooted in case processing and compliance reporting to a safety program built around benefit-risk management.
How to meet the rigorous safety and efficacy demands critical to evaluating newer targeted cancer therapies.
A follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.
A follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.
A follow-up survey on clinical quality assurance (CQA) assesses current industry best practices compared to a decade ago, and provides recommendations on this key component of quality management for the future.
The information in this article serves as a good start by providing factors to keep in mind if your organization is considering adopting ePRO. Appropriateness of ePRO often varies by study and is evaluated individually. As the research landscape continues to shift, being prepared will help ensure a successful IRB review of your study and facilitate a smoother research process overall.
The information in this article serves as a good start by providing factors to keep in mind if your organization is considering adopting ePRO. Appropriateness of ePRO often varies by study and is evaluated individually. As the research landscape continues to shift, being prepared will help ensure a successful IRB review of your study and facilitate a smoother research process overall.
An overview of clinical supply blinding methods in the context of the current research environment.
An overview of clinical supply blinding methods in the context of the current research environment.
An overview of clinical supply blinding methods in the context of the current research environment.
Planning for ethnic sensitivity from a scientific and regulatory perspective.
Planning for ethnic sensitivity from a scientific and regulatory perspective.
Planning for ethnic sensitivity from a scientific and regulatory perspective.
Planning for ethnic sensitivity from a scientific and regulatory perspective.
Industry news focusing on the people and organizations who work in the clinical trials profession.
Work is needed if true efficiencies are to be gained in clinical trial performance.
Planning for ethnic sensitivity from a scientific and regulatory perspective.
Planning for ethnic sensitivity from a scientific and regulatory perspective.
Planning for ethnic sensitivity from a scientific and regulatory perspective.
Community-based recruitment engages multiple stakeholders in a collaborative approach.
PRO measures enrich the evaluation of treatment effectiveness and help sponsors differentiate products.
Addressing patient dropout with an arsenal of tools that leverages both technology and communication.
Community-based recruitment engages multiple stakeholders in a collaborative approach.
The statistics show that fewer and fewer physicians are willing to take part in trials and that around half of those that do so once never do so again.
Accelerating the discovery and delivery of personalized medicine.
Accelerating the discovery and delivery of personalized medicine.
While several studies and surveys have examined the relationship between sponsors and CROs, there has been little analysis of CRO-investigative site relationships. This study uncovers useful learnings on the positive and negative experiences of investigators in their direct dealings with CROs.