Current Edition

Translation Services – A Key Component in
Volume 13 Issue 1

Translation Services – A Key Component in Successful Clinical Trials

JCS speaks with Craig Brown of Dora Wirth (Languages) Ltd, on steps companies can take to avoid faulty translations The language used in clinical trial …

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addressing personal
Volume 13 Issue 1

Addressing Personal Protection Shortages During COVID-19 Pandemic

Since the beginning of the COVID-19 public health emergency, the FDA has been working to facilitate the development and availability of medical products and equipment …

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Striving for Cold Chain Sustainability
Volume 13 Issue 1

Striving for Cold Chain Sustainability

Pharmaceutical companies, transportation providers, clinical customers and packaging vendors are increasingly focusing on the environmental impact associated with conducting clinical trials or the transportation or …

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Data Collection Strategy
Volume 13 Issue 1

Data Collection Strategy in a Post-COVID-19 World

The fundamental responsibility of Data Management teams in clinical trials is to ensure the collection of accurate data needed as per study protocol requirements. Deepu …

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Achieving GCP Compliance in Oncology
Volume 13 Issue 1

Achieving GCP Compliance in Oncology Trials: The Balance between Obligation, Idealism and Realism

Good Clinical Practice (GCP) provides an internationally accepted standard to ensure subject safety and data integrity in clinical trials incorporating ethical and scientific guidelines. Amer …

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Opioid Sparing
Volume 13 Issue 1

Opioid Sparing: Prescribing Less is Insufficient

Chronic and post-surgical pain that opioids are intended to alleviate have been offset by a host of societal pains stemming from the prevalence of opioid …

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Managing Human Challenge Trials
Volume 13 Issue 1

Managing Human Challenge Trials: A Case Study

Volunteer infection studies or controlled human infection models (CHIMs) are an extremely effective way to gather early clinical evidence on a new drug or vaccine’s …

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Ensuring Patient Safety and Cardiovascular
Volume 13 Issue 1

Ensuring Patient Safety and Cardiovascular Clinical Trial Integrity during a Globa Pandemic

The susceptibility to and the outcomes of COVID-19 are strongly associated with the presence of CV risk factors and with established CV disease. Clinical trials …

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Impact of COVID-19 on Clinical Research
Volume 13 Issue 1

Impact of COVID-19 on Clinical Research in Malaysia

The novel coronavirus disease (COVID-19) pandemic has impacted global economies. These disruptions, also experienced by the global industry-sponsored research (ISR) industry, required new guidelines and …

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Global Outsourcing and Vendor Management
Volume 13 Issue 1

Global Outsourcing and Vendor Management: Key Influence Factors and Strategies

In the pharmaceutical industry, about one-third of all drugs in the pipeline of the top ten pharmaceutical companies were initially developed elsewhere. Sponsor companies have …

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