CROs Posts

Clinical Trials Guidance: Q&A with Patrick Stone

Mark Crawford

Patrick Stone is president and lead consultant for TradeStone QA LLC in Austin, Texas (www.tradestoneqa.com). A strong advocate for human subject protection, his specialties include bioresearch monitoring in human clinical and pre-clinical trials. The following interview focuses on the FDA and clinical trials. (more…)

As Pharma Cuts Back, CROs Do More

Mark Crawford

Reacting to market and regulatory forces, pharmaceutical science continues to adapt and survive.Years of downsizing and reduced R&D budgets, combined with the “patent cliff” that many large pharmaceutical companies are facing, have resulted in tens of thousands of layoffs, flooding the job market and creating aftershocks felt throughout the industry. Regulatory changes are also hitting hard. New FDA requirements, especially those focusing on long-term studies, have lengthened internal development timelines and increased costs. The overall effects of these changes are reduced drug applications and less innovation, with fewer products in the pipeline. (more…)