Clinical Trials

Japan's Step Towards Global Studies

A new guideline on trial data provides opportunities for Japanese biopharmaceutical companies and global contract research organisations to work together to speed up drug development in Japan.

Adaptive Trial Design

Enhancing the quality of clinical trials

Adaptive / flexible trial design has begun to catch-up with the clinical trial services providers due to its umpteen benefits that go a long way in delivering better drugs in a much shorter time. This article looks at different types of adaptive designs available, their characteristics, infrastructure, and the associated legal aspects.

Metabolomics Strategy

Identifying tissue-specific drug effects

The maturation of metabolomics technologies is expected to have profound effect on pharmaceutical R&D. Over the past few years, technologies have matured to the stage where comprehensive and quantitative investigation of global metabolome has been made possible.

Clinical Outsourcing in Japan

Ready to fulfill its Destiny?

With the increasing popularity of global and regional trials in Japan, most global pharma companies are looking to develop as many compounds in Japan as possible. Yet, with limits to headcount increases, companies face limited options to achieve their business goals.

Clinical Trial Integration

Adopting an Innovative Approach

A clinical trial interchange platform can solve complex data integration challenges and also provide enterprise reporting, searching and aggregation capabilities.

Site Management Organisations in Asian Clinical Trials

Providing Competitive Advantage

In a changing market for clinical trials where fast recruitment of large patient numbers is of the essence, Site Management Organisation (SMOs) operating as independent CRO divisions offer significant advantages in the Asian market.

Clinical and Non-Clinical Investigations

Improving the quality of development candidates

Improving the quality of the exploratory development candidates selected to go into confirmatory clinical development should further reduce the risk of late stage failures.

Ethics in Clinical Trials and Drug Development

Ethical considerations have a multiplicity of roles during the conduct of clinical trials-from matters related to the design of a study, to the conduct and even to the reporting of results.

Decision Making in Drug Development

Innovative designs

Bayesian designs are particularly suited for early drug development as they combine historical information with current trial data to make decisions on toxicity, efficacy or futility.

Foreign Biotech Trials in Asia

Emerging trends

Asian countries seem to be welcoming foreign clinical trials, which create job opportunities for researchers, scientists and medical professionals and also bring new therapies to the country.

China

Clinical trial strategies for small pharma

Utilising a company that is based in China and understands both ICH GCP and China SFDA GCP requirements is very important for ensuring clinical trial integrity and success.

Developing Opportunities

Adoption of best project management and drug development practices have driven significant changes within clinical trials in Asia and Eastern Europe. Eric Morfin discusses the many opportunities now available in these new and growing areas.

New Demand, New Horizons

The Asia Pacific region has seen spectacular growth in large-scale clinical trials in recent years. Iylen Benedict highlights the reasons for the shift and outlines some of the challenges and synergies involved.

Advertorial

Added-Value Clinical Trials

A Bangalore-based company specialising in clinical trials is taking advantage of the recent change in intellectual property laws.

Growth in Japanese Clinical Trial Markets

Added-Value Clinical Trials

Regulatory changes and the acceptance of foreign clinical data have fuelled growth of the clinical trial sector in Japan.