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Showing "adopts Veeva Systems clinical trial management system" PubMed Articles 1–25 of 58,000+

A management system for randomized clinical trials: A novel way to supply medication.

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.

A Good Practice-Compliant Clinical Trial Imaging Management System for Multicenter Clinical Trials: Development and Validation Study.

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 ...

Prototype of running clinical trials in an untrustworthy environment using blockchain.

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...

Conceptual Framework to Support Clinical Trial Optimization and End-to-End Enrollment Workflow.

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.

Self-Management in Long-Term Prostate Cancer Survivors: A Randomized, Controlled Trial.

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.

Establishing an Interoperable Clinical Trial Information System Within MIRACUM.

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...

Creating an immunization content database for knowledge management across clinical systems.

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.

Randomized Prospective Clinical Trial of Class II Restorations Using Low-shrinkage Flowable Resin Composite.

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.

The Impact of Patient Interactive Systems on the Management of Pain in an Inpatient Hospital Setting: A Systematic Review.

 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.

Orthodontic referral management systems: Do they make a difference?

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.

Successful At-Home Use of the Tandem Control-IQ Artificial Pancreas System in Young Children During a Randomized Controlled Trial.

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.

Automated Text Messaging With Patients in Department of Veterans Affairs Specialty Clinics: Cluster Randomized 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.

Artificial Intelligence for Clinical Trial Design.

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...

Development and Evaluation of a Clinical Decision Support System to Improve Medication Safety.

 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.

A randomized controlled clinical trial evaluating efficacy and adverse events of different types of recombinant human bone morphogenetic protein-2 delivery systems for alveolar ridge preservation.

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.

Current interventions to promote safe and appropriate pain management.

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 effectiveness of acupressure in the management of depressive symptoms and in improving quality of life in older people living in the community: a randomised sham-controlled trial.

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.

Analysis of Different Quality Management Systems in Medical Practices in Saxony.

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.

Assessment of Consistency Between Peer-Reviewed Publications and Clinical Trial Registries.

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.

A review of development and reform of emission permit system in China.

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 ...

Clinical and Cost-effectiveness of a Comprehensive geriatric assessment and management for Canadian elders with Cancer-the 5C study: a study protocol for a randomised controlled phase III trial.

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.

Clinical Outcomes of Pemphigus Patients Treated by the Same Physicians in a Public Safety Net Healthcare System Versus a Private Healthcare System.

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...

OCTANE: Oncology Clinical Trial Annotation Engine.

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.

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