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The article discusses the evolution of outsourcing models in clinical development operations over the last 25 years, particularly focusing on the shift from full-service outsourcing (FSO) to functional service provider (FSP) models. It highlights the emergence of new variations and hybrid models combining elements of both FSO and FSP. It further examines the impact of this shift on contract research organizations (CROs).

The article focuses on the paramount importance of adhering to Good Clinical Practice (GCP) in the realm of clinical trials. It highlights a pivotal incident where Pfizer severed ties with CareAccess, a decentralized clinical trial specialist, due to unspecified GCP violations. It further addresses the challenges posed by protocol deviations inherent in clinical trials and emphasizes that thorough training can mitigate these issues.

The article focuses on harnessing the power of scientific surveillance in centralized monitoring of clinical trials. Topics includes the statistical methods used in centralized monitoring, application of scientific surveillance techniques, and the detection of scientific inconsistencies, risk prediction, and inflated placebo response.

The article discusses the reports the In the pharmaceutical sector, data from clinical trials is only being analyzed on a 20 percent scale. It highlights prospective advantages, including reducing costs, de-risking financial investments, and discovering proof of potential negative consequences. Additionally, it describes the efficiency of clinical trials, pharmacovigilance, and organizations and consortiums that support data integration and interoperability.

This article discusses the impact of travel on patients participating in clinical trials and the environment. It highlights the significant discrepancy between the distance patients travel for routine medical care compared to clinical trial visits, emphasizing that travel is a key barrier to recruitment and retention in clinical trials. The article suggests several strategies to reduce patient and planetary burden, such as utilizing virtual or remote visits, using home healthcare agencies with efficient routing and electric vehicles, incorporating wearables for remote monitoring, and encouraging environmentally friendly modes of transportation. The article also emphasizes the importance of minimizing travel distances for clinical trials and the interconnectedness of patient burden and planetary burden. [Extracted from the article]

The article presents the discussion on remote patient monitoring has become critical to achieving better healthcare outcomes. Topics include technology allows for extended monitoring of patients' health parameters, such as vital signs, medication adherence, and symptom progression, without the need for frequent in-person visits; and wearables must align with the specific goals of the trial and uphold the highest standards of scientific rigor and validation.

The article discusses the ways to optimize risk-based quality management (RBQM) risk detection in order to reduce incorrect diagnosis. It discusses the guidelines by Food and Administration Department (FDA) to reduce complexity and burden of clinical research, further discussed role of risk-based monitoring (RBM) in risk-based quality management (RBQ) which incorporates good clinical practice (GCP), and discussed RBQM methodology which reduces false detection.

In the article, the authors discuss the evolution of clinical trials from the use of papyrus to technology-driven data collection solutions. Other topics include the need to ensure data quality and integrity (DQI), the need for the pharmaceutical industry and regulators to refrain from using paper-based processes as gold standards, and the claim that the first clinical trial was conducted by King Nebuchadnezzar of Babylon as recorded in the Bible book of Daniel.

The article offers information about the Bayesian Methods to Expedite Learning. It mentions that Bayesian methods bring flexibility and speed to clinical trial design and analysis, and with increased access to the necessary computational power and transforming today's clinical research. It discusses that Bayesian dose-finding approaches such as the continual reassessment method.

The article focuses on Clinical trial stakeholders weigh in on the major shifts unfolding in the era of COVID-19, as efforts move away from the traditional site-based model. Topics inlcude the pandemic driving a long-awaited trend away from the traditional site-based study model toward one that being patient-centric, and the Tufts Center for the Study of Drug Development (CSDD) found no significant differences in the mean number of patients enrolled per site.

The article suggests strategies for implementing risk based monitoring (RBM) and risk-based quality management (RBQM) activities in clinical trials. Topics include the planning to start the development of the target product profile (TPP); risk of identification of critical data and processes depends on multiple stakeholders, including the Drug safety Inc. and the Medical affairs Co.; and selection of vendors for risk based monitoring.

This article discusses the Food and Drug Administration ongoing efforts to enhance oversight of food and medical product safety. It mentions revisions to inspection and compliance programs, influenced by the pandemic's remote oversight practices. It further emphasizes a risk-based approach for monitoring investigational studies.

The article offers information on how much traditional approaches in clinical operations need to change to meet new expectations for clinical delivery. Topics discussed include views of Rob Metcalf, vice president (VP) at drug maker Eli Lilly, on drug development, the implementation of a new Unified Clinical System and views of Jim Reilly, VP at software company Veeva Systems, on clinical operations.

The article reports that I f you haven't had the opportunity to attend the Drug Information Association (DIA) Global Annual Meeting (GAM) held each year in June, this would be the year to do it. From June 19-23 in Chicago, this year's DIA theme is "Innovation through Collaboration." Tamei Elliott, senior manager of scientific programs with the DIA, said, "DIA has seen tremendous effort across the globe.

The article focuses on a study regarding the clinical trial sites in Eastern Europe that reveals that the clinical research sites potential in Eastern Europe are underutilized in terms of performance. Topics discussed include observation of poorly resourced clinical trial sites with restricted funding from government, lacking of market knowledge in the hospitals and high number of clinical trial activities in Eastern Europe regardless of challenges faced by companies.

The article focuses on data monitoring committees (DMCs) which are created to advise a clinical research organization during the conduct of clinical trials. It reports that DMCs work to preserve the integrity of the trial and protect the safety of study participants. Further discussed are models for implementation of DMCs which include Do It Yourself models in which sponsors have full control over the data and full outsourcing models which are handled by contract research organizations (CROs).

The article offers information on several plans to increase the speed in disease treatments from clinical trials to patient utilization. Among the plans include the development of chips that mimics the human tissues, improvement of data management tools, and efficient translational research. Also mentioned are the causes of the prolonged pre-implementation periods such as the occurrence of uncontrollable events, underestimation on the duration of project completion, and lack of coordination.

The article discusses COVID-19 pandemic forces compliancy within organizations following FDA's 2018 revision of Good Clinical Practice in federal registry. Topics include clinical trials characteristically produce massive amounts of data for study staff to sift; and quality risk assessments, starting at protocol development and ending with database lock,.

The article focuses on the regulatory and business assumptions for adopting tools and processes that are related to monitoring and can provide higher quality trial data at a lower cost. It mentions that the eClinical forum risk-based monitoring taskforce provides effective methods for assuring the quality of the clinical data. It also provides certain beneficial details that are related to the elements that can be considered for evolving risk-based approaches to clinical trial monitoring.

Judy Canavan, Managing Director, Global Employer Services of BDO said, "The sense that [CRAs] can own their career is important, and organizations are really not enabling employees to do that." Applied Clinical Trials • April 2021 11 appliedclinicaltrialsonline.com CLINICAL OUTSOURCING TURNOVER FOR CLINICAL MONITORING REMAINS HIGH BDO recently released its annual CRO Insights Report for 2020/2021 (see: https://bit.ly/39grb41). For this most recent edition of the report, the main headline continues to be a high rate of employee turnover within CROs, particularly for the CRA role. [Extracted from the article]

The article highlights the findings of the survey of the periodical and its partner SCORR Marketing on digital integration, managing data sources. Topics discussed include improving the quality of clinical trials monitoring; difficultly in understanding the different RBM approaches; and the views of Shelley Padgett, director at Eli Lilly & Co. on exploring the third-party solutions needed for company's infrastructure.

The article discusses the views of the author on navigating a decentralized trial model during COVID. Topisc discussed include these conditions will continue to be uncertain for the foreseeable future, so sponsors have little option other than to take an agile approach; and the work of talented and skilled clinical research associates (CRAs) is perhaps more vital than ever, as they are on the front lines navigating how the evolving clinical landscape impacts them and patients.

The article offers information on the Linking Leaders private roundtable featuring leaders from the clinical development operations sector in late April 2012. Topics discussed includes the effect of changing sponsor-provider partnerships, the impact of the growth of outsourcing on sponsor oversight responsibilities, and improvement of site performance by site management. Participants of the roundtable includes Michelle Katz, Craig Wozniak, and Andrew Lee.

The article offers information related to the efforts of regulators for risk-based oversight of clinical trials. It mentions that the research community has been slow to embrace strategies for reducing on-site oversight to reflect risk. It also mentions that sponsors appear willing to spend more to ensure that results meet regulatory expectations and avoid raising issues that can delay the review and approval of a market application.

The article discusses the concept of blockchain in applied clinical trials for development of a interoperable, and auditable platform that enables investigational product (IP) to be tracked from point of manufacture to consumed by the patient. Topics include the partnership of Hu-manity.co with International Business Machines (IBM) to use blockchain platform as its global consent ledger, and commercial use of personal information.

The article focuses on the practical application of risk-based monitoring (RBM) in clinical trials. It mentions that central statistical monitoring can improve RBM solutions by effectively identifying errors, sloppiness, and tampering. It also presents information on CluePoints that is a central statistical monitoring solution that can improve the clinical data quality over traditional on-site monitoring methods.

The article focuses on the guidance related to the implementation of risk-based monitoring (RBM) in clinical research. It mentions that by incorporating a holistic evaluation of each individual study starting with a multi-disciplinary risk assessment and associated plan development the successful implementation of RBM in clinical trials can be made. It informs that RBM can reduce the cost of clinical studies by approximately 20-30 percent in service fees.

The article focuses on the application of Risk-based monitoring (RBM) for making drug development a more effective process while providing high quality results on time and under the budget. It mentions that RBM carefully analyzes the sources that impose meaningful threats to the goals of clinical development. It suggests identifying variables related to program risks and determining the elements that affect patient safety for the successful application of RBM.

The article focuses on the implementation of risk-based monitoring (RBM) in clinical trials. It mentions that by the application of RBM which is also termed as intelligent monitoring, a strategy of implementing risk levels to incoming data generates better signals from that data that produces better quality data for the trial. It also presents information on a conference on Risk-Based Monitoring in clinical studies to be held in Philadelphia, on October 24, 2013.

The article focuses on the application of risk-based monitoring (RBM) in a clinical trial experiment. It mentions that RBM is considered as an alteration in paradigm from the traditional experimental design and execution to clinical trials in which it brings focus. It also mentions that the risk-based monitoring and constant program optimization assists the findings of a clinical research for providing new products to patients.

The article focuses on the statistical modeling solution software called as the CluePoints for risk-based monitoring (RBM), adopted for the GSK Vaccines from the pharmaceutical company GlaxoSmithKline (GSK). It mentions that the CluePoints provides cost effective onsite monitoring. It informs that CluePoints helps in examining abnormal patterns in the data such as repeated measurements which have almost same values, same values carried forward, and too many missing values.

The article informs that the European Union is planning to leave the ethics considerations regarding clinical trials to the national authorities. It states that the European Forum for Good Clinical Practice (EFGCP) has proposed clinical trials rules which splits the procedure into two parts including the European which consist of a list of documents to be submitted and the national component parts will organize the member.

The article discusses the advancement in the field of clinical trial. It notes the use of remote device to continuously monitor clinical trial participants. It indicates that continuous monitoring facilitates subject recruitment, improves participant retention, and eliminates inefficient clinical trial processes. Furthermore, it cites the role of social networks in the transformation of clinical trials.

The article offers information on the U.S. Food and Drug Administration's (FDA) Patient-Focused Drug Development (PFDD) initiative that facilitates patient engagement in the development of new treatments for specific conditions. Topics include scheduling of PFDD meetings by the Center for Drug Evaluation and Research (CDER), funding of the PFDD by the Prescription Drug User Fee Act (PDUFA) program and FDA's Bioresearch Monitoring program (BIMO) for inspecting clinical research sites.

The article reports on the aspects of clinical trials in the pharmaceutical industries. It states that clinical trials are important for drug's approval and as basis for the evidence of efficacy and safety. Also mentioned that clinical trials are affected by several factors such as the treatments, attitudes, and the cultures of different countries that are unique in several aspects.

The article offers the author's insights about rebranding risk-based monitoring (RBM). The author suggests that most organizations engaged in clinical research have been sitting on the edge of the risk-based monitoring pool. He also tackles the declining trend in the percentage of source document verification (SDV) coverage measured industry-wide.

The article discusses various topics related to clinical trials that were published online on a website located at appliedclinicaltrialsonline.com. Topics discussed include a pie chart which examines the time taken by a company to evaluate and make purchase decisions for technology, a webcast related to risk-based monitoring system in clinical monitoring, and a storage facility for biological samples maintained and operated by the Indiana Clinical and Translational Institute.

The authors present their views on different factors that need to be considered while clinical trials are being conducted, both before the trial commences and also during the trials. The risks associated with clinical trials and data management of the results are of importance. Monitoring of clinical trials to understand a patient's reactions, continuous re evaluation of risk assessments and site analysis are important risks that are checked during the trials.

The article focuses on a risk-based monitoring offered by TransitCelerate BioPharma Inc. as part of its monitoring tools for any type, phase and stage of clinical trial.

A letter to the editor is presented in response to the article ""Flying Blind on CRA Workload, Time Demands," by Kenneth A. Getz in the July 2012 issue.