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Adopts Veeva Systems Clinical Trial Management System PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Adopts Veeva Systems Clinical Trial Management System articles that have been published worldwide.
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Randomized controlled clinical trials require management effort, involving huge organizational, economic and informatics investments. Information technology offers opportunities to approach clinical trial methodology in new ways. However, there are only a few reports of computerized data and drug management systems.
With the rapid increase in utilization of imaging endpoints in multicenter clinical trials, the amount of data and workflow complexity have also increased. A Clinical Trial Imaging Management System (CTIMS) is required to comprehensively support imaging processes in clinical trials. The US Food and Drug Administration (FDA) issued a guidance protocol in 2018 for appropriate use of medical imaging in accordance with many regulations including the Good Clinical Practice (GCP) guidelines. Existing research on ...
Monitoring and ensuring the integrity of data within the clinical trial process is currently not always feasible with the current research system. We propose a blockchain-based system to make data collected in the clinical trial process immutable, traceable, and potentially more trustworthy. We use raw data from a real completed clinical trial, simulate the trial onto a proof of concept web portal service, and test its resilience to data tampering. We also assess its prospects to provide a traceable and us...
In this work, we present a conceptual framework to support clinical trial optimization and enrollment workflows and review the current state, limitations, and future trends in this space. This framework includes knowledge representation of clinical trials, clinical trial optimization, clinical trial design, enrollment workflows for prospective clinical trial matching, waitlist management, and, finally, evaluation strategies for assessing improvement.
This randomized clinical trial compared a personally tailored, automated telephone symptom management intervention to improve self-management among long-term survivors of prostate cancer with usual care enhanced with a nontailored newsletter about symptom management. We hypothesized that intervention-group participants would have more confident symptom self-management and reduced symptom burden.
In the long-run we wish to demonstrate the power of linking clinical trial information to routine health records for straightforward patient recruitment - not only at each single hospital but in a large German consortium (called MIRACUM). In such architecture a hospital wide clinical trial registry (CTR) plays a major role. All such site specific CTR however, also need to be interoperable and support automated data provision for a central MIRACUM wide trial registry. Based on a survey of already existing tr...
A initiative at an academic medical center to create a single database of immunization-related content to inform the build and configuration of immunization-related knowledge assets across multiple clinical systems is described.
The aim of this prospective, randomized, split-mouth clinical trial was to evaluate postoperative sensitivity, clinical performance, and interproximal contacts after using different restorative systems.
While some published literature exists on the use of interactive patient care systems, the effectiveness of these systems on the management of pain is unclear. To fill this gap in knowledge, we aimed to understand the impact and outcomes of pain management patient interactive systems in an inpatient setting.
To assess the performance of the referral management system (RMS) compared to a previous paper-based referral system and to determine whether referrals reflected the patients' malocclusion and met current guidelines.
Hybrid closed-loop (HCL) artificial pancreas (AP) systems are now moving from research settings to widespread clinical use. In this study, the inControl algorithm developed by TypeZero Technologies was embedded to a commercial Tandem t:slim X2 insulin pump, now called Control-IQ, paired with a Dexcom G6 continuous glucose monitor and tested for superiority against sensor augmented pump (SAP) therapy. Both groups were physician-monitored throughout the clinical trial.
Acceptability of mobile phone text messaging as a means of asynchronous communication between health care systems and patients is growing. The US Department of Veterans Affairs (VA) has adopted an automated texting system (aTS) for national rollout. The aTS allows providers to develop clinical texting protocols to promote patient self-management and allows clinical teams to monitor patient progress between in-person visits. Texting-supported hepatitis C virus (HCV) treatment has not been previously tested.
Clinical trials consume the latter half of the 10 to 15 year, 1.5-2.0 billion USD, development cycle for bringing a single new drug to market. Hence, a failed trial sinks not only the investment into the trial itself but also the preclinical development costs, rendering the loss per failed clinical trial at 800 million to 1.4 billion USD. Suboptimal patient cohort selection and recruiting techniques, paired with the inability to monitor patients effectively during trials, are two of the main causes for high...
Broadening the Debate About Post-trial Access to Medical Interventions: A Qualitative Study of Participant Experiences at the End of a Trial Investigating a Medical Device to Support Type 1 Diabetes Self-Management.
Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n = 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts blood g...
The Predictive Low Glucose Management System in Prevention of Clinically Significant Hypoglycemia in Type 1 Diabetes. A Preliminary Study Identifying the Most Common Events Leading Up to Hypoglycemia During Insulin Pump Therapy.
Prevention of hypoglycemia remains a major challenge in diabetic management, despite the introduction of modern insulin pumps in daily clinical practice. The Low Glucose Suspend (LGS) and the newer Predictive Low Glucose Management (PLGM) systems incorporated in the Medtronic insulin pumps have shown promising results in prevention of hypoglycemia. Our aim was to evaluate the effect of the 2 systems relative to the frequency of clinically significant hypoglycemia in Type 1 diabetes (T1DM). In addition, we i...
Clinical decision support systems (CDSSs) are a good strategy for preventing medication errors and reducing the incidence and severity of adverse drug events (ADEs). However, these systems are not very effective and are subject to multiple limitations that prevent their implementation in clinical practice.
This 12-week clinical trial evaluated efficacy and adverse events for two recombinant human bone morphogenetic protein-2 (rhBMP-2) delivery systems in alveolar ridge preservation.
Describe patient-, clinician-, system-, and community-level interventions for pain management developed and employed by 9 healthcare systems across the United States and report on lessons learned from the implementation of these interventions.
The primary aim of the current trial was to assess the clinical effectiveness of acupressure in the management of depression in elderly people compared to patients receiving sham acupressure or standard care alone.
Since 1 January 2004, all physicians, psychotherapists and medical care centres on contracts with statutory healthcare in Germany are obliged according to § 135a section 2, no. 2 of the Fifth Social Security Statute Book to introduce and develop an intra-institutional quality management system. Thus, physicians are faced with the question of which quality management system is best suited to their own practice.
Clinical trial registries are intended to increase clinical research transparency by nonselectively identifying and documenting clinical trial designs and outcomes. Inconsistencies in reported data undermine the utility of such registries and have previously been noted in general medical literature.
An emission permit system (EPS) is a fixed-source environmental management system that is widely practiced worldwide. Since 2016, China has been building a fixed-source environmental management system with the EPS as its core. This paper summarizes the evolutionary process of China's EPS over the past 40 years considering four main stages: embryonic stage, local pilot stage, total emission control-based exploration stage, and reform stage of the core management system. This paper notes that China initially ...
Geriatric assessment and management is recommended for older adults with cancer referred for chemotherapy but no randomised controlled trial has been completed of this intervention in the oncology setting.
Healthcare may be influenced by the healthcare system to which the patient is aligned as well as the characteristics of the patients within a given healthcare system. The University of Southern California (USC) has two healthcare systems on the same campus - the private system (PS) University Hospital for patients with healthcare insurance and the safety net system (SNS), Los Angeles County Hospital for indigent patients. The same USC physicians provide care in both systems. This article is protected by cop...
Many targeted therapies are currently available only via clinical trials. Therefore, routine precision oncology using biomarker-based assignment to drug depends on matching patients to clinical trials. A comprehensive and up-to-date trial database is necessary for optimal patient-trial matching.