Authors
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Investigators’ Experiences in Cooperation with CROs in Clinical Trials in FinlandWhile 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.
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New Survey Measures the Pulse of RBM & ICH-E6 (R2) Adoption in the Clinical Trials IndustryAbby Abraham, Vice President, Data Analytics, and RBM for OmniComm Systems, writes about a new survey that highlights gaps in the conversation surrounding the industry’s adoption and implementation of risk-based approaches to monitoring.
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A Guide to Risk-Based Study StartupFor organizations looking to increase transparency in the study startup process, the sheer volume of data and the silos in which they exist can be a daunting hurdle. New generation systems enable teams to capture, analyze, share, and visualize study startup data in one system.
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An IRB’s Perspective on ePROThe 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.
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Pharmaceutical Industry and Pediatric Clinical Trial Networks in Europe – How Do They Communicate?Pair of surveys provide a rare formal peek into the relationship between sponsors and pediatric clinical research networks. A lack of awareness, incongruent expectations, and insufficient communication have hindered collaboration between the two parties. Developing standardized procedures and better information exchange could help strengthen the connection going forward.
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Pharmaceutical Industry and Pediatric Clinical Trial Networks in Europe – How Do They Communicate?Pair of surveys provide a rare formal peek into the relationship between sponsors and pediatric clinical research networks. A lack of awareness, incongruent expectations, and insufficient communication have hindered collaboration between the two parties. Developing standardized procedures and better information exchange could help strengthen the connection going forward.
Latest:
Pharmaceutical Industry and Pediatric Clinical Trial Networks in Europe – How Do They Communicate?Pair of surveys provide a rare formal peek into the relationship between sponsors and pediatric clinical research networks. A lack of awareness, incongruent expectations, and insufficient communication have hindered collaboration between the two parties. Developing standardized procedures and better information exchange could help strengthen the connection going forward.
Latest:
Pharmaceutical Industry and Pediatric Clinical Trial Networks in Europe – How Do They Communicate?Pair of surveys provide a rare formal peek into the relationship between sponsors and pediatric clinical research networks. A lack of awareness, incongruent expectations, and insufficient communication have hindered collaboration between the two parties. Developing standardized procedures and better information exchange could help strengthen the connection going forward.
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Clinical Trials, Social Media and Your PatentConsiderations should be made in regard to social media and clinical trials. Public use and disclosure of an invention before filing for a patent can invalidate the claims and locating evidence to demonstrate public use of an invention can be challenging, particularly if the use is not commercial or publicized.
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Top 3 Patient-Centric Payment TrendsWhen paying and reimbursing clinical research volunteers for study participation, what can be done to make the experience more patient centric?
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mHealth: Trendy or Revolutionary?mHealth is making a strong case for its ability to optimize clinical trials and improve engagement with participants and patients.
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Digital Health Devices & Data in Trials TodayIn this eBook, industry leaders Validic, Quintiles and Duke Clinical Research Institute explore the four categories of digital health technologies--wearable fitness devices, clinical devices, sensors and applications-and discuss what each category includes, endpoints they collect and how they’re being used in trials today.
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An Ideal SOP SystemA "can’t live with them, can’t live without them" attitude is revealed in survey of standard operating procedures in the management and conduct of clinical trials.
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Accelerating Clinical Trials With Proper Assay Development and ValidationIn this video, Dr Loren Blake (Study Director, FSP Solutions) and Jack Bradley (Executive Director) from LabConnect share their keen insights on the challenges that sponsors currently face in clinical trials, as well as ways to overcome them to accelerate outcomes.
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Immunotherapy. It’s Working.With the initial promise of immunotherapy use in oncology, we need to continue supporting cross-industry collaborations among leaders from the biopharma community, academia, regulators, and private sector investors.
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Impact of Actigraphy in Clinical ResearchWith all the buzz around wearables, actigraphs-which monitor sleep and daytime activity levels-have been around for decades.
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Data Privacy Concerns Between EU-US IntensifiesReactive, hastily enforced regulations can easily jeopardize the sound conduct of a clinical trial and its data flow, potentially threatening both subject safety and data quality.
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Building Blocks for Better BalanceWhile block randomization has been shown to be a more frequently used form of trial randomization design, the use of dynamic randomization has been shown to have optimal treatment group balancing results.
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An Adaptive-Block Randomization Method when Stratifying by Investigator in Small-to Medium-Sized StudiesA novel adaptive-block method of randomization to maximize the efficiency of overall treatment group balance, while maintaining balance at investigational centers in smaller sized studies, is proposed.
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A Comparison of Techniques for Creating Permuted Blocked Randomization ListsTwo of the most important elements to the integrity of a controlled clinical trial are the patient randomization and the treatment blinding. With a focus on block pattern distribution, four methods of randomization list creation are analyzed.
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The Benefits of Advanced Imaging Management SystemsHow new technology can impact cardiac imaging in oncology clinical trials and have broader implications for patient safety.
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Enhanced Site Training, Resources, and CommunicationSurvey drills down on the preferences and experiences of clinical trial site personnel in critical function areas such as site initiation and monitoring, training, sponsor interaction, and patient recruitment and retention.
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Enhanced Site Training, Resources, and CommunicationSurvey drills down on the preferences and experiences of clinical trial site personnel in critical function areas such as site initiation and monitoring, training, sponsor interaction, and patient recruitment and retention.
Latest:
Enhanced Site Training, Resources, and CommunicationSurvey drills down on the preferences and experiences of clinical trial site personnel in critical function areas such as site initiation and monitoring, training, sponsor interaction, and patient recruitment and retention.
Latest:
Enhanced Site Training, Resources, and CommunicationSurvey drills down on the preferences and experiences of clinical trial site personnel in critical function areas such as site initiation and monitoring, training, sponsor interaction, and patient recruitment and retention.
