Product Details

Tracking major changes in the R&D pipeline

A new CenterWatch analysis finds that growth in therapeutic areas has shifted during the past five years, with rheumatoid arthritis and psoriasis showing increased levels of activity. And sponsorship of the pipeline has changed significantly, as small biopharmaceutical companies now sponsor the majority of R&D activity.

Will investigator certification improve site performance?

A doctor is required to have board certification in his or her specialty in order to practice on patients. Yet, if that same doctor decides to participate in a clinical trial, he does not need any special certification to sign a 1572 and conduct research on human subjects. Pharmaceutical companies don’t request any certification from Principal Investigators (PIs). Neither do CROs. And the FDA does not require it. So what’s the incentive for a doctor to take yet another exam?

Also in this issue:

• Using a data collection standardization method
• Tips for choosing the right CRO in CEE
• Regulatory Update
• Month in Review
• FDA Actions
• Study Lead Opportunities
• New Drugs in the Pipeline