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Volume 16 Issue 2
 
CDISC & CDASH – Interconnecting Clinical Programming and Clinical Data Management
Editorial Archive

CDISC & CDASH – Interconnecting Clinical Programming and Clinical Data Management

SDTM is the most stable and better understood of the CDISC Clinical Data Standards. SDTM is very prescriptive and, although there is ‘wiggle room,’ there is not as ...
21 August 2015 Editorial Archive | IT & Logistics V7 I4 | Volume 7 Issue 4
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Clinical Trial Material Storage and Distribution – A Critical Mission
Editorial Archive

Clinical Trial Material Storage and Distribution – A Critical Mission

Manufacturing investigational medicinal products (IMP)s and ancillary supplies is a complex process, and it is subject to change at every stage. There is much at st...
20 August 2015 Editorial Archive | IT & Logistics V7 I4 | Volume 7 Issue 4
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Therapeutic Vaccine Development
Editorial Archive

Therapeutic Vaccine Development

Biological medicine has saved the lives of millions around the world and has prevented morbidity and mortality by developing vaccines for human use. A number of pro...
20 August 2015 Editorial Archive | Therapeutics V7 I4 | Volume 7 Issue 4
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Optimising MRI in Multiple Sclerosis Drug Development
Editorial Archive

Optimising MRI in Multiple Sclerosis Drug Development

Multiple sclerosis (MS) is a devastating disease affecting approximately one million people worldwide, and is the most frequent cause of disability in young adults,...
20 August 2015 Editorial Archive | Therapeutics V7 I4 | Volume 7 Issue 4
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The Challenges of Implementing Non-interventional Studies in the EU
Editorial Archive

The Challenges of Implementing Non-interventional Studies in the EU

The European Medicines Agency (EMA) is piloting both adaptive pathways, to shorten time to market, and parallel scientific advice so that benefits and risk data req...
20 August 2015 Editorial Archive | Market Report V7 I4 | Volume 7 Issue 4
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Key Factors for Procuring Translation Services for Clinical Trials
Editorial Archive

Key Factors for Procuring Translation Services for Clinical Trials

Running clinical trials is an operation involving many different specialisations. Thus, the clinical trial industry has always been – even more so in recent years –...
20 August 2015 Editorial Archive | Market Report V7 I4 | Volume 7 Issue 4
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Converge or Be Purged: IDMP Product Standardisation Deadline Looms
Editorial Archive

Converge or Be Purged: IDMP Product Standardisation Deadline Looms

The Identification of Medicinal Products (IDMP) is a set of standards defined by the International Organization for Standardization (ISO). The initiative has enjoye...
20 August 2015 Editorial Archive | Regulatory V7 I4 | Volume 7 Issue 4
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Electronic Trial Master File: Gaining Efficiency for Oversight and Control
Editorial Archive

Electronic Trial Master File: Gaining Efficiency for Oversight and Control

Maintaining an electronic Trial Master File (eTMF) is far more than storing study documents on the sponsor’s file server. EMA’s reflection paper on Trial Master Fil...
20 August 2015 Editorial Archive | Regulatory V7 I4 | Volume 7 Issue 4
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Less is the New More: Risk-based Approaches in Clinical Trials
Editorial Archive

Less is the New More: Risk-based Approaches in Clinical Trials

The continuously evolving clinical research industry requires new solutions and renewed approaches. Rising costs, studies getting more and more complex and, what is...
20 August 2015 Editorial Archive | Regulatory V7 I4 | Volume 7 Issue 4
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Moving from Paper to Mobile: Validation of Mobile ePRO
Editorial Archive

Moving from Paper to Mobile: Validation of Mobile ePRO

Patient-reported outcomes research (PRO) is indispensable in demonstrating the clinical efficiency of any medical treatment or procedure. This type of research, his...
20 August 2015 Editorial Archive | Volume 7 Issue 4 | Watch Pages V7 I4
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