Current Edition

Assessing Study Design and Matching
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 what they perceived …

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Interim Report Shows FDA Meeting Goals for
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), provided for in …

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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 collaborators have had …

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A Novel Approach to Clinical Supply Chain
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 addressed …

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Prevention is Key
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 …

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Preparing – at Last – for IDMP Adoption
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 …

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Communicating with Patients
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 patient information is apathy, …

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Clinical Trials in Medical Devices
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 …

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Nursing Report Sheet_ An Essential Tool for
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 …

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From Little Acorns_ A Scandinavian Study’s
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 …

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