Article 465: A New Era Begins for India's Clinical Research Market

• India's participation in global clinical trials has nearly quintupled between 2001 and 2005, as investment in the country by large international and domestic pharmaceutical companies, small and medium-sized Western biotechs and the National Institutes of Health has grown as well. The clinical research outsourcing market in India grew to $70.5 million last year and will continue to climb. India’s business and regulatory climates have undergone dramatic change in the past 18 months through passage of a patent bill, regulations updated to harmonize with U.S. and international standards, and plans for a more FDA-like regulatory body.

Article 466: eClinical Alphabet Soup: EDC, CTMS and EHR

• Electronic data capture (EDC) companies are offering more integrated systems as they seek to provide enterprise-wide solutions including such features as clinical trial management system and interactive voice response systems. Will moving EDC toward electronic health records be the ultimate integration play for this niche industry? Part I of a Two-Part Series...

Article 467: Concept of Compassionate Use Gathers Pace in Europe

• A growing number of European investigators and patient groups agree that those in need should have speedy access to safe and effective products. But regulators and sponsor companies are concerned that early access could compromise drug safety and generate a heavy administrative burden. But regulators and sponsor companies are concerned that early access could compromise drug safety and generate a heavy administrative burden. In addition, regulators are wary that compassionate-use programs could be misused as early marketing launches or allow drugs to achieve high prices during early access that would remain once released to the wider population of patients.

Article 468: Eye on: Kidney Cancer

• Of approximately 180,000 new cases of kidney cancer diagnosed each year worldwide, more than half occur in North America and the European Union...