Current Edition

Ensuring inspection readiness at clinical facilities
Volume 11 Issue 5

Ensuring Inspection Readiness at Clinical Facilities

The principles of Good Clinical Practice (GCP) serve to ensure the protection of trial participants and the integrity of the data recorded. Katrien Lemmens at …

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Digesting the alphabet soup data standarts
Volume 11 Issue 5

Digesting the Alphabet Soup of Data Standards

Harmonisation of data standards has been a popular topic recently at the US Food and Drug Administration (FDA) and other regulatory organisations. Governmental regulation attracts …

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Successful oncology trials need
Volume 11 Issue 5

Successful Oncology Trials Need Intelligent Supply Management

As clinical trials become more complex, so does the task of ensuring the right supplies are in the right place at the right time. Protocol …

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Planning for early access programmes
Volume 11 Issue 5

Planning for Early Access Programmes

Early access programmes are becoming more common and more sophisticated, requiring greater attention and resources from sponsors. The FDA’s pilot programme is designed to help …

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Living in the data stream
Volume 11 Issue 5

Living in the Data Stream: Managing Patient and Study Metrics

Clinical research is changing rapidly alongside the growing prevalence of “smart” technology. Data is being generated beyond traditional clinical settings – originating in disparate locations …

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Are regulatory service providers over-estimating
Volume 11 Issue 5

Are Regulatory Service Providers Over-estimating AI’s Potential Impact on Process Transformation?

Within the next three years, the pharma and biotech industries will be at a point of deploying AI and machine learning to transform the pace …

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Adjust in time_beware of the challenges
Volume 11 Issue 5

Adjust in Time: Beware of the Challenges Annex VI Brings for Labelling

Five years after Clinical Trial Regulation (EU) first came into force, development of the clinical trials portal and database that will trigger its official application …

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EU Clinical trials regulation and protection
Volume 11 Issue 5

EU Clinical Trials Regulation and Protection of Personal Data

Personal data concerning health should include all data pertaining to the health status of a data subject which reveal information relating to the past, current …

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The public's growing appetite for
Volume 11 Issue 5

The Public’s Growing Appetite for Product Data

As momentum builds anew towards ISO IDMP compliance, life sciences companies could be forgiven for a lacklustre response, after a series of delays. Most organisations …

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North Africa an underestimated
Volume 11 Issue 5

North Africa; an Underestimated Region with Huge Potential for Clinical Trials

North Africa is the region covering the northern part of the African continent and can be defined as the area covering Morocco, Algeria, Tunisia, Libya, …

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