Agile/Scrum Adoption in Regulated Industries
According to the 2013 State-of-Scrum Report, Agile/Scrum is being practiced in 33% of highly regulated industries like finance, healthcare, insurance…
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Get Back – Managing your Return Logistics for Clinical Trials
Over the last ten years, the way that the pharmaceutical industry is expected to deliver new drug products to market…
Mobile ePRO as a Cost-effective Method of Patient Data Capture
As digital technology plays an increasingly important part in our everyday lives, it comes as no surprise that it has…
Can mHealth be thought of as the Default Solution for Accelerating Completion and Increasing Success Outcomes in Clinical Trials?
Clinical trials are the experimental foundation on which modern medicine is built. Human medicines cannot be sold without permission from…
Understanding the Importance of Mobile Health for Pharma
Mobile health (mHealth) may be the buzzword of today, but unlike many other buzzwords, this one will not be just…
Pyoderma Gangrenosum: A Systemic Review of the Incidence and Prevalence
Pyoderma gangrenosum (PG) is a rare and serious skin disease in which a painful nodule breaks down to form progressive…
Comparison of Marketing Authorisation and its Requirements for Brunei Darussalam and Indonesia
The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries of…
Centralised Monitoring: A Smart and Cost-efficient Approach
The clinical monitoring cost is one of the major costs and accounts for one-third of the overall cost of clinical…
Cardiac Safety Investigations 10 Years after ICH Guidance E14: – Evolving Industry and Regulatory Viewpoints on Evaluation of Proarrhythmic Risk during New Drug Development
The year 2015 marks the 10th anniversary of the release of two ICH Harmonised Tripartite Guidelines that have governed the…
Overcoming Regulatory Challenges in Cognitive Drug Development
In recent years, numerous pharmaceutical and biotechnology companies have undertaken development programmes intended to assess the efficacy of various pro-cognitive…