Patient Data Reporting Featured Articles

81. Adverse Event Reporting On Social Media — What You Need To Know 7/17/2018

    Adverse events (a suspected reaction to the API or to the API in combination with prescribed medicines or environmental factors) are, naturally, a challenging situation for patients in a clinical trial and may, in rare cases, become severe or even fatal. For sponsors, contract research organizations (CROs), and logistics partners, early notification and accurate information is vital to understanding and responding to a suspected adverse event. What happens if the patient goes off protocol and turns to social media?

82. Self-Deception — The 3 Most-Repeated Lies Of Trial Master File QC 7/12/2018

    Achieving inspection readiness means that during all stages of a clinical trial, a regulatory inspector would be able to walk into the building and reconstruct the trial using only the documents and metadata present in the trial master file (TMF). Although the concept of an inspection-ready TMF may be simply described, inspection readiness is not easily achieved. The failure to achieve an inspection-ready TMF continues to be an area of growing risk for the clinical research industry.

83. 6 Insights To Broaden Your Understanding Of Clinical Trial Data Management 6/7/2018

    In your opinion, what’s the No. 1 problem when it comes to clinical trials?

84. Edgy Observations On Clinical Site Documentation Management: Leading Or Bleeding? 3/6/2018

    For an investigational trial, clinical site documentation encompasses many types of records. These cover every aspect of patient care, policy guidance, and study execution. Not only does the patient medical history and care need to be maintained, but documentation supporting the plan and evidence of execution of a clinical trial must also be managed. This extensive collection of information is always subject to regulatory inspection.

85. 3 Keys To Successful Blockchain Adoption In Clinical Research 3/1/2018

    Excitement around the potential for blockchain platforms continues to build. This parallels the surge in popularity of blockchain-based cryptocurrencies such as Bitcoin. Meanwhile, “critics argue it’s all hype — a technological hammer looking for a nail — and that the complexities of health information prevent practical use of blockchain technology.”

86. Decrypting The Utility Of Blockchain In Clinical Data Management 1/16/2018

    According to a common refrain, blockchain will “transform” and “disrupt” the life sciences industry. While the technology’s applications in industries such as banking and broader financial services are readily apparent and, in fact, already being adopted, tangible applications in the life sciences prove more nebulous.

87. Clinical News Roundup: FDA Awards Funding To Pediatric Clinical Trials 11/10/2017

    Clinical news roundup for the week of November 6^th with information on FDA funding pediatric trials, clinical trials for heroin addicts, Marken’s home delivery app, Seeker’s patient enrollment portal, and minority recruitment in trials.

88. Janssen Takes Clinical Supplies And Patient Data From Paper To Digital 11/9/2017

    Janssen is seeking to replace paper-based conventional processes of managing clinical supplies and tracking patient health data with a new suite of cohesive digital technologies. The new iSTEP (Integrated Smart Trial & Engagement Platform) is a technology toolset developed to automate investigative product supply and data management in clinical studies.

89. A Critical Juncture For Clinical Trial Data Management 11/2/2017

    Data management functions are managing a much higher volume and diversity of data in response to the increasing scope and demands of global drug development programs. Real-world data and evidence, electronic clinical outcome assessments, data from smartphones and mobile devices, social media community data, and electronic health/medical records are examples of the variety of new data sources now captured during a clinical trial.  The volume and diversity of data presents integration, compatibility, and interoperability challenges that must be optimized to improve drug development performance and efficiency.

90. Clinical News Roundup: CRS Files Lawsuit Against FDA 10/26/2017

    Clinical News Roundup for the week of October 23, 2017 with information on CRS’ lawsuit against the FDA, FDA boosting patient access to medical devices, the Bracket acquisition of mProve, why Alzheimer’s drugs fail, and more.