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Volume 13 Issue 5

Scientific and Ethical Issues Surrounding the Enrolment of Pregnant People in Clinical Trials

Through recent actions, the US Food and Drug Administration (FDA) has signalled its commitment to advancing research in pregnant and lactating people, recognising tha...
18 October 2021 Volume 13 Issue 5 clinical trials | FDA
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Volume 13 Issue 5

What is Cognitive Debriefing?

Cognitive debriefing is a language test of a linguistically validated questionnaire of healthy volunteers or patients with a specific disease to prove that the transl...
18 October 2021 Volume 13 Issue 5 Clinical Studies | Cognitive Debriefing
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Volume 13 Issue 5

Clinical Quality Management System (CQMS): A Framework for Operational Excellence and Compliance with Good Clinical Practice (GCP)

What defines “quality” within the framework of clinical research? To answer this question, one has to step back and start with the definition of “quality” per se. Uni...
18 October 2021 Volume 13 Issue 5 Clinical Quality Management System | clinical research
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Volume 13 Issue 5

Operationalising Decentralised Clinical Trials (DCTs)

The Challenges and Change Management Approaches, Considering Trial Designs and Timelines with Decentralisation Methods at the Forefront While components of fully dec...
18 October 2021 Volume 13 Issue 5 clinical trials | COVID-19
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Volume 13 Issue 5

Overview: Pharmacovigilance and Risk Management

Drug development is an expensive, lengthy, and high-risk business taking 1015 years and is associated with a high attrition rate. Approximately only 1 in 10 drugs tha...
18 October 2021 Volume 13 Issue 5 drug development | Market Overview
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Volume 13 Issue 5

Finding the Right Patients for Primary Care Clinical Studies

Automated Recruitment Platforms (ARPs) offer primary care clinicians and allied health professionals’ opportunities for more time-efficient ways to engage with and re...
18 October 2021 Volume 13 Issue 5 ARPs | Clinical Studies
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Volume 13 Issue 5

Plain Language Summaries of Publications – What Has COVID-19 Taught Us?

The COVID-19 pandemic has significantly impacted the whole world and the public has had to struggle with understanding scientific data on a daily basis. The impact of...
18 October 2021 Volume 13 Issue 5 COVID-19 | Language
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Volume 13 Issue 5

Clinical Evaluation of Ayurvedic Interventions: Current Scenario in Indian Market

Ayurveda, the science of life, has evolved into a comprehensive system of healthcare based on high-quality scientific experiments with a sound and reproducible eviden...
18 October 2021 Volume 13 Issue 5 Ayurvedic | Clinical Evaluation
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Volume 13 Issue 5

Considerations for Clinical Trial Design Involving Radiotherapy

Radiation therapy has been used for many years as an effective form of treatment against many cancer types, yet it remains less well researched and utilised than othe...
18 October 2021 Volume 13 Issue 5 cancer | clinical trial
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Volume 13 Issue 5

Modernising Study Management for Greater Visibility and Speed in Trials

Clinical trial complexity is growing as the industry adapts to COVID-19 disruptions, increasing data sources, and evolving patient expectations. Add on the fact that ...
18 October 2021 Volume 13 Issue 5 Case Study | CTMS
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