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Author(s):  
Sharon V Medendorp ◽  
Allison Crumpler

Effective management of a clinical trialrequires having real time access to information that provides useful insightsinto trial progress and that lends itself to collaborative decisionmaking.  Data visualizations using datafrom multiple source systems employed during the conduct of a clinical trialhave become an essential tool in the recent past as support for collaborativedecision making by project teams. Having the ability to access, analyze, read,work with, and present data to support an argument are  important skills that ensure datavisualizations fulfill their purpose in clinical trial management. There is anexpectation that members of the clinical trial team either possess or developthe data literacy skill sets necessary to collaborate on the successfulexecution of a clinical drug development trial. Here we describe thedevelopment of a Data Learning Series program targeted to increase the data literacyskills within a Contract Research Organization in support of the digitalevolution of the drug development industry.


Author(s):  
Sharad Desai ◽  
Nilesh Patel

Nowadays health agencies of regulated markets are becoming stringent regarding the bio-studies. So clinical/contract research organization (CRO) need to be selected carefully after their detailed assessment. As per requirement of bio-study CRO should be assessed with the study specific checklist of questions before awarding the bio-study. Questions related to various services of study like: Clinic phase, analytical phase, Pharmacokinetic and statistical phase, ethics approval, QA/QC, record handing etc. and related to CRO capabilities are discussed here with their relevance to conclude the abilities of CRO for successful execution of bio-study. Hence, this paper focuses all possible questions which need to be assessed before selection of CRO mainly for Bioavailability/Bioequivalence (BABE) study in healthy adult volunteers. Properly selected CRO will help for smooth execution of study and quality report and subsequently, hassle-free approval of dossier submitted to regulatory agency.


Bioanalysis ◽  
2021 ◽  
Author(s):  
Daisy Yuill ◽  
Chiara Carla Rospo ◽  
Henko Tadema ◽  
Jade Louber ◽  
Sijranke Post

As the number of therapeutic modalities expand, and the field of scientific research evolves toward finding treatment solutions for complex and rare disease, an ability to demonstrate efficacy through biomarker end points in clinical development studies is becoming increasingly important. Implementing flow cytometry in a clinical setting is challenging and many sponsor organizations take a hybrid approach, developing complex analytical methods internally before identifying and forming partnerships with contract research organizations to conduct the formal analytical method validation and sample bioanalysis. Ensuring that these interactions are effective is critical to the delivery of high-quality, impactful clinical data. This paper provides a review of the recommendations, challenges and solutions for the implementation of decision-making flow cytometry end points effectively utilizing the Sponsor Contract Research Organization interaction.


2021 ◽  
Vol 16 (3) ◽  
pp. 87-91
Author(s):  
Poonam Chauhan ◽  
Monica Mendonca

The evolution of the drug development process and testing its efficacy is a primary responsibility of pharmaceutical companies. The time cost investment involved in identifying a compound suitable to its target disease and making it available to the masses eventually led to the rise of the Contract Research Organization (CRO) in the domain of clinical research.  Pharmaceutical companies outsource the research and clinical trials to CRO’s. A CRO has a vital role from drug discovery to the launch and marketing of drugs. India is emerging as attractive location for global clinical trial. It has cost advantage compared to other countries and a well-developed associated services like data management, medical writing and pharmacovigilance.  The Central Drug Standard Control Organization (CDSCO) is the National Regulatory Authority in India that aims to bring safe drugs and standardize clinical research. Pharmaceutical Companies benefit by strategically working with CRO to gain speed and efficiency in drug discovery, generation and retention of clinical data integrity. The risk associated with CRO relates to delays and inferior quality of work, thereby making CRO a critical decision for Pharmaceutical Company.


10.2196/26813 ◽  
2021 ◽  
Vol 23 (7) ◽  
pp. e26813
Author(s):  
Romée Melanie Helena Coert ◽  
James Kenneth Timmis ◽  
André Boorsma ◽  
Wilrike J Pasman

Background Conventional clinical trials are essential for generating high-quality evidence by measuring the efficacy of interventions in rigorously controlled clinical environments. However, their execution can be expensive and time-consuming. In addition, clinical trials face several logistical challenges regarding the identification, recruitment, and retention of participants; consistent data collection during trials; and adequate patient follow-up. This might lead to inefficient resource utilization. In order to partially address the current problems with conventional clinical trials, there exists the need for innovations. One such innovation is the virtual clinical trial (VCT). VCTs allow for the collection and integration of diverse data from multiple information sources, such as electronic health records, clinical and demographic data, patient-reported outcomes, anthropometric and activity measurements, and data collected by digital biomarkers or (small) samples that participants can collect themselves. Although VCTs have the potential to provide substantial value to clinical research and patients because they can lower clinical trial costs, increase the volume of data collected from patients’ daily environment, and reduce the burden of patient participation, so far VCT adoption is not commonplace. Objective This paper aims to better understand the barriers and facilitators to VCT adoption by determining the factors that influence individuals’ considerations regarding VCTs from the perspective of various stakeholders. Methods Based on online semistructured interviews, a qualitative study was conducted with pharmaceutical companies, food and health organizations, and an applied research organization in Europe. Data were thematically analyzed using Rogers’ diffusion of innovation theory. Results A total of 16 individuals with interest and experience in VCTs were interviewed, including persons from pharmaceutical companies (n=6), food and health organizations (n=4), and a research organization (n=6). Key barriers included a potentially low degree of acceptance by regulatory authorities, technical issues (standardization, validation, and data storage), compliance and adherence, and lack of knowledge or comprehension regarding the opportunities VCTs have to offer. Involvement of regulators in development processes, stakeholder exposure to the results of pilot studies, and clear and simple instructions and assistance for patients were considered key facilitators. Conclusions Collaboration among all stakeholders in VCT development is crucial to increase knowledge and awareness. Organizations should invest in accurate data collection technologies, and compliance of patients in VCTs needs to be ensured. Multicriteria decision analysis can help determine if a VCT is a preferred option by stakeholders. The findings of this study can be a good starting point to accelerate the development and widespread implementation of VCTs.


2021 ◽  
Vol 12 (2) ◽  
pp. 17-34
Author(s):  
Tabitha Andersen ◽  
Dylan Cawthorne

What happens when an engineer attempts to address the value-neutral paradigm and the holistic deficits in engineering science? This paper sets out to account for the interplay between an unmanned aerial system engineer acting as a “champion” of value sensitive design (VSD) and their more objectivist research organization. Action research methods are used by the authors in an attempt to implement VSD in a real-world research organization and thereby bridge the theory-practice gap. Primary empirical data are collected which indicate the engineer has internalized and often utilizes a VSD approach. Both barriers and catalysts to wider adoption of VSD within the organization are experienced, and recommendations for overcoming paradigmatic, strategic, structural, and cultural barriers are addressed. This work demonstrates how action research can be used to shift engineering away from a value-neutral paradigm towards the value-sensitive approach advocated by the authors.


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