As academic, non-profit and other medical and public health officials seek to address health issues in developing parts of the world, life sciences companies have increased their reliance on emerging markets to meet recruitment goals for their development programs. And while global standards exist, policy makers, regulators, and some citizens suspect these standards are lower in emerging markets than in the West.
“I’m looking forward to partnering with MRCT to devise more effective solutions for issues that surround multi-regional clinical trials”, said Cindy Henderson, vice president of operations at Veristat, who will sit on MRCT’s Steering Committee. Our 20 year history as a Clinical Research Organization (CRO) provides us with a depth of knowledge about the importance of ensuring consistency and transparency around data submissions and trial protocols. We are glad to be able to share that expertise with our colleagues in the industry.”
According to MRCT, a 2008 OIG Report on Foreign Clinical Trials indicates that 80 percent of the drugs approved for sale had trials in foreign countries, with 78 percent of all subjects who participated in clinical trials enrolled at foreign sites.
Henderson continued, “The ultimate goal of any regulatory agency submission is to determine its efficacy and safety. Adhering to data compilation and submission standards and creating clear and thorough study protocols affords the sponsor, the regulatory agencies and ultimately the general public (both international and domestic) a greater degree of confidence in the final product.
Bringing 20 years of experience to its clients, Veristat is a clinical research organization (CRO) that supports pharmaceutical, biotechnology and medical device companies through every phase of the clinical trial process, as well as the preparation of integrated summary documents and submission-ready CDISC data for regulatory filings. Visit www.veristat.com.