RFP Reform: The Problem With Getting What You Ask For
Although many pharma companies do not realize it, their RFPs block the path to greater success. Pharma companies and innovative CROs have a strong shared interest in refocusing procurement efforts...
Peer Reviewed: International Express
The economic downturn has forced pharma companies large and small to re-examine many business practices. Boom times forgive inefficiency; recessions punish it without mercy. Continued reliance on...
The Agile Approach - More Efficient International Trials
A biotech company's high-stakes confirmatory study of a new biologic treatment of brain metastases involved 92 sites in eight countries. When the FDA rejected the company's application for...
Peer Reviewed: Operations and the Future of Adaptive Research
After more than a decade of effort expended and billions of dollars invested, a development program has failed to produce data. The science seems promising and the experimental design seems as if...
Seamless Designs in Adaptive Research
With growing appreciation of drug development as a continuous process, the notion of defining best doses and then rolling straight into pivotal studies utilizing the identified best doses becomes...
CROs Can Make Enormous Leap with Adaptive Operations
An "enormous leap in productivity" can be achieved by applying the principles of adaptive trials to broader operations, such as recruitment, according to a CEO that thinks CROs have to adopt the...
Enrollment: Situation Difficult But Manageable
A recent article in The New York Times described how a variety of enrollment issues are hindering progress in oncology research. If anything, the article understates the challenges of enrollment....
The Case for Making All Studies Operationally 'Adaptive'
The time- and cost-saving benefits of adaptive clinical trials (ACT) will be lost on companies unless they can generate an uninterrupted flow of information on which adaptations will be based....
Health Decisions Celebrates 20 Years of Adaptive Clinical Research
In building a company of some 150 employees over the past two decades, Health Decisions founder and CEO Michael Rosenberg has presumably done something right. But he maintains the industry is still...
Research Efficiency In Hard Times: It's Time To Adapt
Nobody likes hard times, but they do have one redeeming quality: They focus attention on areas neglected in good times. The need for greater efficiency is a prime example, especially for small drug...
