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"Faith Haines Kolb is one of the most experienced clinical researchprofessionals working in the field today. As we continue to expand ourservices in the clinical research areas that are critical for our clients atPROMETRIKA, her demonstrated strengths in project management, monitoring,electronic data capture, and working successfully with global researchnetworks will be a tremendous asset for us moving forward," said MiganushStepanians, PhD, president and CEO of PROMETRIKA.
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Prior to joining PROMETRIKA, Ms. Kolb was chief technical officer atAverion International Corporation, an international clinical researchorganization. At Averion she was responsible for the company's operationalperformance in the United States. Prior to joining Averion, she was directorof clinical IT at PAREXEL International Corporation.
"In my work I have seen the many challenges in pharmaceutical productdevelopment facing companies in the U.S. and around the world. With a strongfocus on improving clinical research services for pharmaceutical,biotechnology and medical device companies, PROMETRIKA is setting a newstandard in terms of efficiency and quality control for clinical trials. I amvery pleased to be joining this dynamic team," Ms. Kolb added.
The clinical operations team at PROMETRIKA provides research planning andexecution services to support product development in pharmaceuticals,biologics and medical devices for companies around the world. Team leadersare responsible for project planning and management, including monitoringenrollment, research schedules, third party vendor management, budgeting andperformance metrics. They also coordinate services related to datamanagement, biostatistics and medical writing for data collection andanalysis, internal and external reporting, and regulatory filings.
According to a research study by CMSInfo, spending on clinical trials inthe United States reached $24 billion in 2005, and it is projected to rise to$32.1 billion by 2011. The Congressional Budget Office in the United Statesestimates that by 2003 the average cost to develop a drug that represents anew molecular entity (NME) reached $802 million and the development timelinefor NME drugs required an average of 7.5 years of clinical stage research.
"Increasingly, clients are looking to us for new approaches involvingelectronic data capture and other technologies that can maximize researchefficiency without compromising quality and accuracy. With Faith's experiencein these areas, PROMETRIKA is better prepared than ever before to be acomprehensive resource to help our clients plan and execute strategic andsuccessful clinical research programs," Ms. Stepanians added.
About PROMETRIKA
Founded in 2003, PROMETRIKA, LLC, is a full service contract researchorganization with headquarters in Cambridge, MA. The company provides a fullrange of clinical research services to pharmaceutical, biotechnology andmedical device companies. PROMETRIKA's team has managed hundreds of clinicaltrials from Phase 1 pharmacokinetic crossover trials to Phase 4 long-termmulti-center studies. The company has extensive experience in all areas ofclinical trial management, including strategic planning, data collection andanalysis, and regulatory filings, including new drug applications in the U.S.and Europe. For additional information
