Medidata’s DCTs make up an ecosystem of tools, people, and processes. The promise and potential of decentralized clinical trials (DCTs) are great, but execution and delivery of the right technologies matters in optimizing patient, site, and sponsor experiences. Today’s clinical trial technologies allow patients to complete clinical trial activities remotely to create better patient experiences while enabling sponsors and clinical research organizations (CROs) to execute faster, smarter trials and sites to focus on patient care, rather than administrative duties. Proactive risk mitigation for research data quality issues to help prevent trial delays.Įmpowering a risk-based approach to source data verification by focusing on critical data.Ī cloud-based remote site access and monitoring solution. Quickly and accurately develop investigator grant budgets.Ī dynamic digital solution for risk assessment, monitoring, and mitigation.Ī powerful data & risk surveillance tool to improve data integrity & reduce trial risk. Unify your clinical research study data and financial management in one platform. Manage electronic trial master file content while maintaining readiness & compliance. Improve speed and efficiency for the oversight of studies with Rave CTMS (Clinical Trial Management System). 7, 13–14 (2008).Drive faster timelines across the trial lifecycle with centralized data & analytics.Ī streamlined, single digital endpoint adjudication system. The use of electronic data capture tools in clinical trials: web-survey of 259 Canadian trials. The Pink Sheet 73 < (11 April 2011).Įl Emam, K. Disclosing drug discovery failures would aid regulatory science, FDA's Hamburg says. Publication of clinical trials supporting successful new drug applications: a literature analysis. The Wealth of Networks (Yale University Press, 2006). Utility of adiponectin as a biomarker predictive of glycemic efficacy is demonstrated by collaborative pooling of data from clinical trials conducted by multiple sponsors. The BATTLE Trial: personalizing therapy for lung cancer. Biomarker-led adaptive trial blazes a trail in breast cancer. Cutting Edge < (15 July 2011).Īllison, M. Clinical Operations: Benchmarking per-patient costs, staffing and adaptive design. Metabolic and immune parameters at clinical onset of insulin-dependent diabetes: a population-based study. Health and Human Services September, 2001). The Globalization of Clinical Trials: a Growing Challenge in Protecting Human Subjects (US Dept. The Economic Times < (15 July 2008).ĭHHS Office of the Inspector General. Clinical trial biz likely to be $546 mn by 2011: Assocham. The placebo effect in irritable bowel syndrome trials: a meta-analysis. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. Measuring the incidence, causes, and repercussions of protocol amendments. Drugs, money and glory: is cancer beating cardiovascular disease? < (11 August 2011). Trial watch: phase III and submission failures: 2007–2010. Drug R&D spending fell in 2010, and heading lower. The errors have been corrected in the HTML and PDF versions of the article. In addition, it should have been noted that Eric Westin, who was interviewed while senior director of Lilly Oncology, had left the company. If they delay in responding, a reminder can be sent.” And for space reasons, other text relating to Recruit, “The tool is integrated with Pfizer’s volunteer database and allows immediate text message-based communication and assessment of a subject’s suitability within 5-10 min” and “It can also be used to send protocol-specific messages to patients already enrolled in trials” was deleted. 3) via their mobile phones or home computers. Instead of “new technology to recruit patients faster and in a more standardized fashion, ”the text now reads, “new technology to allow home-based clinical trial data reporting.” Instead of “‘Recruit’ text messaging technology in a pilot study” for Detrol, the text now reads, “‘eDiary’ tool in a Phase 4 trial, called Research on Electronic Monitoring of OAB Treatment Experience.” Additional explanation has been added, including “Patients can respond to simple questionnaires (Fig. The text references to Recruit have been replaced with an explanation of eDiary. The Recruit technology is being used in other studies. In the version of the article originally published, the ExoInTouch product being used by Pfizer in its virtual trial for overactive bladder (OAB) is eDiary, not Recruit, which allows patients to report through mobile phone or internet portals.
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