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 …
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 …
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 …
Multiple sclerosis (MS) is a devastating disease affecting approximately one million people worldwide, and is the most frequent cause of disability in young adults, after …
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 …
Running clinical trials is an operation involving many different specialisations. Thus, the clinical trial industry has always been – even more so in recent years …
The Identification of Medicinal Products (IDMP) is a set of standards defined by the International Organization for Standardization (ISO). The initiative has enjoyed cross-border support, …
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 …
The continuously evolving clinical research industry requires new solutions and renewed approaches. Rising costs, studies getting more and more complex and, what is more important, …
Patient-reported outcomes research (PRO) is indispensable in demonstrating the clinical efficiency of any medical treatment or procedure. This type of research, historically conducted using pencil …
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