Advances in electronic data capture and management are converting paper-based clinical trial data to digital formats, improving the efficiency of clinical trials, and enabling sponsors to bring new drugs to market faster. Clinilabs, a Manhattan-based clinical trials company, is delivering these advances and fulfilling an important industry need.

Clinilabs is a privately-held, technology-based clinical trials organization that provides critical drug development services to sponsors. The mission of Clinilabs is to develop and manage information systems that streamline clinical trials processes and increase the likelihood of successful outcomes in clinical trials. It achieves this mission by providing electronic data management, Web-based clinical trials recruitment, Phase I – IV development, and other essential services.

One example of the services offered by Clinilabs is embodied in its electronic data management platform. This platform provides centralized, electronic data management in an environment that is compliant with Federal regulations. Clinilabs' proprietary systems are designed to standardize data collection across sites involved in multicenter trials, minimizing error and reducing statistical variance. According to Dr. Gary Zammit, president and CEO of Clinilabs, "our data management methodologies can make the difference between a successful trial and a failed one. We also help clients realize the long-term value of their drug portfolios by delivering successful trial results in a time-efficient manner."

Recently, the benefits of centralized data management were realized in a large, multicenter study. More than 30 sites were involved, but Clinilabs enabled all of them to collect electronic data in a uniform way. The bottom line is that the sponsor received a clean database and is confident of the results of statistical analyses.

Another prominent element of Clinilabs' portfolio of services is its proprietary, Web-based subject recruitment platform. Subjects learn about clinical trial opportunities while searching for information on the Internet, and are directed to Clinilabs' Web sites where they can "pre-screen" for participation in clinical trial projects. Those who successfully pre-screen are directed to trial locations in their geographic areas. According to Dr. Zammit, "traditional advertising methods used in clinical trials are costly and their yields are low." However, Clinilabs has developed a method that exposes more than 50,000 potential study candidates per week to information about clinical trials. "We pre-screen hundreds of people every day using our automated Web-based system" says Jeanine Falinski, Director of Subject Recruitment. "We can have a huge impact on enrollment, without the high cost of traditional advertising." She adds that "one important feature of our system is that it allows the sponsor or regulatory authority to track a research participant from his first point of contact with a trial."

The centerpiece of Clinilabs' operation is its clinical trials site in Manhattan. Here, PK, PD, and Pharma-co-EEG Phase I studies are conducted, as well as proof-of-concept and specialty Phase II – IV studies. According to Dr. Kathleen Rice, Director of Clinical Research, "our multi-bed unit provides sponsors with critical information. In early stages of development, we want to be the source of information that helps sponsors make "go" or "no go" decisions, and in later stages we want to adhere to good clinical practices that maximize the likelihood of a drug's separation from placebo."What does Clinilabs envision for the future? "Electronic technologies are rapidly changing the clinical trials industry, and this sector will grow exponentially in the next two years," says Zammit. "We envision a high rate of growth in New York, since it is where pharma, technology transfer, and finance merge." Information about Clinilabs can be found at http://www.clinilabs.com or call 212-994-4560.

Clinilabs, 1090 Amsterdam Ave., 17th Floor, New York, NY 10025, http://www.clinilabs.com, info@clinilabs.comPhone: (212) 994-4560 Fax: (212) 994-5101