DSG, Inc. and Pegus Research Partner in Population Safety Trial for Major International Pharmaceutical Company.

DSGeIUs eCaseLink is Managing Data Collection

MALVERN, Pa. -- DSG, Inc. today announced that Pegus Research is using DSGeIUs eCaseLink EDC software to conduct a Population Safety Trial (PST) to evaluate the safety of a prescription drug. The trial is being conducted for a major international pharmaceutical company.

The trial will include 1,000 subjects at 36 pharmacies throughout the country. It went live in August 2006 and will continue through January 2007. The trial is being entirely eSourced with data being entered directly into the computer and no hard copy source documents. This is the second trial in which DSG and Pegus Research have partnered.

eIuA PST can produce the safety data required by regulatory agencies in less time than required by other methods, and using eCaseLink saves an even greater amount of time because there are no hard copy source documents. Everything is electronic,eIN said Tony Varano, CEO of DSG.

The PST, also known as an Actual Use Trial, is being conducted to provide data to support a prescription to over-the-counter (OTC) switch. The PST will measure the effectiveness of the labeling directions for appropriate dosing and duration of use for the drug as well as warning statements. This method has proven efficient in collecting information about usage patterns and adverse events for drugs as they enter the prescription market or make the transition to the non-prescription market.

eIuThe PST is a new switch strategy we developed to assess the safety of a drug in the population of actual users who use the study drug the way they normally would. Our expertise in designing and implementing actual use research to support OTC switch applications led to the development of this new method, which has been used by many leading health and consumer product campaigns globally,eIN said David McCammon, president of Pegus Research.

Participants are enrolled into the study through a network of 36 pharmacy enrollment sites. Clinical interviewers follow up with participants by telephone to gather data about how the drug was used.

Since 1992, DSG, Inc. has supported clinical trial data collection with innovative technology solutions including EDC, electronic patient diaries and digital on-demand CRF publishing management software. DSGeIUs products allow user friendly, accurate and efficient data capture at any investigator site regardless of the siteeIUs technological infrastructure. DSG has successfully supported over 200 clinical trials at more than 300 companies, at over 14,000 sites worldwide. For more information, please visit www.dsg-us.com.

PEGUS Research has managed care studies and population risk trials for a variety of pharmaceutical companies, consumer product safety companies, and managed care companies. PeguseIU PST method has been used by many leading health and consumer product campaigns in the US and internationally. The company manages scientific research from study design and project development through data collection and analysis to final reporting. For more information please visit www.pegus.com.