Clinical Trials

Clinical trials industry is constantly evolving, and also new clinical studies are being launched at an ever-growing pace. Clinical trial services have widely regarded as the principal method for obtaining a reliable evaluation of treatment effect on patients. Conducting clinical trials is a growing trend in the medical industry for testing the safety level and effectiveness of a newly developed medical device or drug. They provide the reliable basis for evaluating the efficacy and safety of new treatments in clinical trials industry. The historical perspective, present status, and future strategy for clinical trials provide a contextual framework.

Use of Real World Evidence

Increasing throughout Asia

Real World Evidence RWE can be used to inform decisions throughout the life cycle of a drug from development through postapproval Across Asia many countries have begun incorporating real world evidence and while some are fast adopters in terms of RWE collection and use other countries have shown les..

Patient Recruitment

An industry challenge

To address the challenges faced in patient recruitment and retention in clinical trials innovative technologies are being utilised in AsiaPacific as well as other regions to optimise the processes involved From patient matching to improving the consent process technology has the power to help Biopha..

Demystifying Biomarker Discovery

The discovery of a disease biomarker using mass spectrometry involves careful planning and strategy The article describes how a rheumatoid arthritis biomarker was identified and explains various steps in biomarker discovery..

Retention of Subjects

The question of informed consent

Although the factors that lead to the loss of subjects in clinical trials are poorly understood lost to followup is still too frequently recorded as an outcome This article explores the issues involved in the planning and conduct of clinical trials and suggests a number of practical and relatively s..

Mobile Phones Always There Always On

Why not use It to enhance patient compliance, trial effectiveness and reduce trial cost

With rapid growth of mobile smart phones and discovery of remote diagnostics devices there are enormous opportunities to use mobile technologies and integrated wireless devices during clinical trials to improve patients medication regimen reduce dropouts reduce site visits and improve clinical data ..

Clinical Trials in China & Japan

Dynamic opportunities for sponsors and CROs

This article focusses on how to leverage the regional strengths of key AsiaPacific countries such as China and Japan in clinical trials while at the same time proactively ensuring consistency and quality..

Innovation for Growth

Glenn Saldanha who has steered the organization for the last nine years holds a Bachelors Degree in Pharmacy from Mumbai University and is an MBA from Leonard Stern School of Business New York University Prior to Glenmark Saldanha has worked with Eli Lily USA and PricewaterhouseCoopers USA..

Developing Benefit-Risk Management Programmes

Best practices

There are four distinct elements to consider in developing benefitrisk management programmes They are protocol design and review active surveillance provider and patient education and appropriate use programmes The entire programme from design through implementation and maintenance will be overseen ..

Optimising the Site Selection Process

Assessment of investigator motivation

Identifying sites which enroll in line with expectations represents a major challenge in clinical research This article discusses strategies to address this challenge and explores the golden site profile concept..

Accelerating Central Nervous System Trials

Neurophysiological approaches

WTechniques such as electroencephalography and evoked potential are useful tools for translation of preclinical findings into Phase I studies These methods can be used early on to show the presence or absence of central action and adverse effects of investigational compounds speeding the search for ..