CRO/Sponsor

This Asian market holds great potential for the future, including possible collaborations with global pharma partners.

Much has been written about the staggering costs of drug development and how the low Phase III success rates across the pharma industry have contributed to these costs. While safety outcomes explain many failures during the early development phase and have likewise played a prominent role in some highly publicized product withdrawals, efficacy failures in Phase III have received little attention. What we now know, however, is that a significant number of Phase III failures are attributable neither to issues of safety nor product differentiation, but to an inability to confirm efficacy against placebo.

This innovative method increases flexibility, saves money, and supports the Critical Path Initiative.

Virtual tools and processes are a key way to decrease costs while increasing quality.

Addressing the health needs of host nations while guarding against subject exploitation and other pitfalls.

Achieving quality viral biomarker data from around the globe that measure up to standard protocol requirements

A high-quality medical infrastructure and low costs make South Africa--largely an untapped opportunity--an attractive alternative for conducting clinical trials.

Following more than two decades of growing involvement in nearly all aspects of drug development, full-service and niche-services contract research organizations (CROs) have become a common and integral part of most sponsor companies' clinical research teams.

What you need to know to save the bottom line...and your sanity.

Target Health and Infacare used a CRF database to answer all of FDA's questions.

A new paradigm that could transform a drug failure into a drug success would narrow the target population to those patients most likely to benefit from such treatment.

Certain clinical project metrics are heavily influenced by country-specific regulations or conditions, such as IEC review times.

A delay in receiving one piece of information may have a severe impact on later parts of the process, such as label text.

The Declaration of Helsinki requires that control groups receive the “best” current treatment, not the “local” one. This shift in wording has profound implications.

Our training places heavy emphasis on site selection: The entire study may suffer if sites are chosen poorly.

The CRO industry is on a course for continued rapid growth with the rise of genetics and genomics, as well as the push toward partnering and more postapproval research.

The idea for this ACT CRO Retrospective came from the first SoCRA meeting I attended in 2003, just as I took over the position of Editor-In-Chief. I had the good fortune to hear PRA International's President and CEO, Patrick K. Donnelly speak about the CRO industry, and I was inspired by what he had to say. The CRO industry has exploded over the last 12 years. It has endured growing pains and it continues to develop. Therefore what better time than now to hear from the thought leaders who have been involved in the transformation taking place.