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JCS Volume 15 Issue 3
 
Assessing Study Design and Matching to Systems based on Efficiency and Cost Outline
Volume 13 Issue 3

Assessing Study Design and Matching to Systems based on Efficiency and Cost Outline

Prior to the pandemic, a survey was conducted asking clinical professionals from pharma, clinical research organisations, clinical sites, and clinical vendors alike ...
14 June 2021 Volume 13 Issue 3
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Interim Report Shows FDA Meeting Goals for Efficient, Transparent Review of Biosimilars Applications
Volume 13 Issue 3

Interim Report Shows FDA Meeting Goals for Efficient, Transparent Review of Biosimilars Applications

The Program for Enhanced Review Transparency and Communication for 351(k) biologics license applications (BLAs) of the US Food and Drug Administration (FDA), provide...
14 June 2021 Volume 13 Issue 3
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Pandemic Industry Impact – One Year On
Volume 13 Issue 3

Pandemic Industry Impact – One Year On

The pandemic has taken its toll, transforming many markets and sectors irrevocably. Organisations operating within the clinical trial space alongside cold chain coll...
14 June 2021 Volume 13 Issue 3
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A Novel Approach to Clinical Supply Chain Systems Integration
Volume 13 Issue 3

A Novel Approach to Clinical Supply Chain Systems Integration

In an era of rapid transformation in clinical trials, research sponsors are presented with new logistical and clinical supply management challenges that can be addre...
14 June 2021 Volume 13 Issue 3
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Prevention is Key: Shifting the Mindset to RBQM
Volume 13 Issue 3

Prevention is Key: Shifting the Mindset to RBQM

Far more than a series of linear quality checkpoints along the way, RBQM spans the clinical trial continuum, scanning data as it accrues and assessing it holisticall...
14 June 2021 Volume 13 Issue 3
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Preparing – at Last – for IDMP Adoption: How Life Sciences Should Ensure Readiness
Volume 13 Issue 3

Preparing – at Last – for IDMP Adoption: How Life Sciences Should Ensure Readiness

The objective of IDMP, to save patient lives, bears repeating, especially given the years that have elapsed since its conception: IDMP will make it easier to mine pr...
14 June 2021 Volume 13 Issue 3
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Communicating with Patients – Who and How?
Volume 13 Issue 3

Communicating with Patients – Who and How?

Even though patient-friendly versions of many regulatory documents are now mandated by the regulations, the most frequently encountered reaction to communicating pat...
14 June 2021 Volume 13 Issue 3
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Clinical Trials in Medical Devices: Life Cycle Risk Management
Volume 13 Issue 3

Clinical Trials in Medical Devices: Life Cycle Risk Management

Risk refers to the chance of suffering loss or injury, or anyone proposing a hazard. The process of risk management identifies, evaluates and prioritises potential h...
14 June 2021 Volume 13 Issue 3
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Nursing Report Sheet: An Essential Tool for the Clinical Research Nurse
Volume 13 Issue 3

Nursing Report Sheet: An Essential Tool for the Clinical Research Nurse

In the past, the research nurse had little time to read the entire protocol and, to manage scheduled visits, they developed nursing summaries of clinical trials. Dis...
14 June 2021 Volume 13 Issue 3
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From Little Acorns: A Scandinavian Study’s Implications for Paediatric Development
Volume 13 Issue 3

From Little Acorns: A Scandinavian Study’s Implications for Paediatric Development

In December 2020, a paper was published in the journal BMJ Paediatrics Open, a respected journal with a relatively modest impact factor of 2.496, regarding paediatri...
14 June 2021 Volume 13 Issue 3
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