Data Management Featured Articles

91. Risk-Based Monitoring: Understanding The Future Of Clinical Trial Monitoring 7/29/2015

    While risk-based monitoring (RBM) has been a popular discussion topic among the clinical research community for quite some time, sponsors and researchers have been slow to implement adaptive strategies. RBM moves away from the traditional approach of frequent on-site visits and 100 percent source data verification (SDV) toward a combination of activities, including centralized data collection and monitoring.

92. How One Bio Company Tackled Its Data Visualization Challenge 7/16/2015

    Data visualization is a problem for many life science companies. Being able to visualize reliable data in real-time, and make smarter decisions faster, is vital to delivering speed and quality across clinical trials.

    While many companies struggle with quality uncertainty and surfacing relevant data trends, those that specialize in rare diseases have a more unique challenge. With rare diseases, trials are open label (patients and researchers both know which drug is being administered) and non-comparative. By design, personnel have access to data in an unblended way. That provides the opportunity to see actual data as it emerges, enabling personnel to understand the data in a way that would not be possible in a blended trial.

93. CISCRP's Fight For Clinical Trial Transparency 7/13/2015

    Research shows that 77 percent of trial participants are never told the result of the trial, despite the fact that 72 percent of them believe it is a very important issue. In Europe, legislation is now pending that would require sponsors to disclose the results of trials, in plain, non-scientific language, via a public registry. Believing this to be an unmet need in the U.S., CISCRP has sent a petition letter to the FDA requesting that a similar system be instituted here as well. But can it work, or will legal concerns stymie the effort?

94. Centralized Monitoring: A Smart Solution For “Oversight” 7/10/2015

    As clinical trial management costs rise because of increasingly complex protocols and stringent regulatory requirements, it has become important to have proper oversight of clinical trials, programs, or projects to avoid any major setbacks and to ensure the achievement of required quality, expected timelines, and return of investment (ROI). Centralized monitoring, if customized and planned properly using the right technology, offers a smart solution for “oversight” of a trial/ program to ensure compliance to protocol and regulatory requirements and to control, mitigate risk/issue(s) on time.

95. Why Do Most Clinical Trials Fail? 7/8/2015

    According to the latest industry research, about 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialization. At first glance, one could conclude that the reason is the stringent FDA review process designed to ensure that only products that deliver an acceptable efficacy and safety profile ever reach consumers. But a more detailed analysis of the results of many clinical research programs tells a different story.

96. Proper Feasibility Planning Is Critical For Clinical Trial Success 6/22/2015

    “Right now, the key to proper feasibility planning is data,” says Paul Evans, VP of feasibility and enrollment solutions for PAREXEL. But just because we have the data doesn’t mean we will always know what to do with it. This is where feasibility enters the picture.

97. How Important Will mHealth Be To Pharma? 6/11/2015

    As mHealth continues to evolve from new phenomenon to mainstay marketing strategy, Michelle Vitko and Sarah Ray, predict its importance in the pharmaceutical industry will continue to grow.

98. Are Your Data Submission Ready? 5 Questions You Should Be Asking 5/19/2015

    In December 2014 the Food and Drug Administration released two final guidance documents and one technical conformance guide related to the content and format of electronic submissions. By Rob Woolson, Chief Strategist Biostatistics and Data Standards for Regulatory Submissions, Rho

99. TransCelerate Moves Forward With Electronic Label Initiative 5/5/2015

    TransCelerate BioPharma has announced an innovative electronic labels (e-labels) information channel to support its member companies. The initiative will work to enhance label usefulness for patients, while providing more consistent labeling approaches for sites. The initiative offers the potential to reduce clinical labeling timelines in the investigational supply chain and create cost efficiencies for pharma companies.  

100. 6 Factors To Consider When Adopting mHealth For Clinical Trials 4/15/2015

     From patient recruitment and retention to expedited data collection, new technologies are poised to simplify trials, create a better patient experience, and hopefully bring down the high cost of trials.