PROMETRIKA, LLC, a contract research organization providing a full range of clinical research services for clients in pharmaceuticals, biologics and medical devices, today announced that Faith Haines Kolb has joined the company as senior director of clinical operations and data management. ??
FAITH HAINES KOLB JOINS PROMETRIKA AS SENIOR DIRECTOR
OF CLINICAL OPERATIONS AND DATA MANAGEMENT
Move further expands PROMETRIKA’s focus in key areas in contract research including clinical trial planning and execution, clinical monitoring, and data management/electronic data capture.
CAMBRIDGE, MA (June 17, 2008) – PROMETRIKA, LLC, a contract research organization providing a full range of clinical research services for clients in pharmaceuticals, biologics and medical devices, today announced that Faith Haines Kolb has joined the company as senior director of clinical operations and data management. With more than 19 years of experience in clinical research, Ms. Kolb has set up and managed multiple large scale clinical research programs from planning through all phases of execution, data management, and reporting.
“Faith Haines Kolb is one of the most experienced clinical research professionals working in the field today. As we continue to expand our services in the clinical research areas that are critical for our clients at PROMETRIKA, her demonstrated strengths in project management, monitoring, electronic data capture, and working successfully with global research networks will be a tremendous asset for us moving forward,” said Miganush Stepanians, PhD, president and CEO of PROMETRIKA.
Prior to joining PROMETRIKA, Ms. Kolb was chief technical officer at Averion International Corporation, an international clinical research organization. At Averion she was responsible for the company’s operational performance in the United States. Prior to joining Averion, she was director of clinical IT at PAREXEL International Corporation.
“In my work I have seen the many challenges in pharmaceutical product development facing companies in the U.S. and around the world. With a strong focus on improving clinical research services for pharmaceutical, biotechnology and medical device companies, PROMETRIKA is setting a new standard in terms of efficiency and quality control for clinical trials. I am very pleased to be joining this dynamic team,” Ms. Kolb added.
The clinical operations team at PROMETRIKA provides research planning and execution services to support product development in pharmaceuticals, biologics and medical devices for companies around the world. Team leaders are responsible for project planning and management, including monitoring enrollment, research schedules, third party vendor management, budgeting and performance metrics. They also coordinate services related to data management, biostatistics and medical writing for data collection and analysis, internal and external reporting, and regulatory filings.
According to a research study by CMSInfo, spending on clinical trials in the 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 States estimates that by 2003 the average cost to develop a drug that represents a new molecular entity (NME) reached $802 million and the development timeline for NME drugs required an average of 7.5 years of clinical stage research.
“Increasingly, clients are looking to us for new approaches involving electronic data capture and other technologies that can maximize research efficiency without compromising quality and accuracy. With Faith’s experience in these areas, PROMETRIKA is better prepared than ever before to be a comprehensive resource to help our clients plan and execute strategic and successful clinical research programs,” Ms. Stepanians added.
Founded in 2003, PROMETRIKA, LLC, is a full service contract research organization with headquarters in Cambridge, MA. The company provides a full range of clinical research services to pharmaceutical, biotechnology and medical device companies. PROMETRIKA’s team has managed hundreds of clinical trials from Phase 1 pharmacokinetic crossover trials to Phase 4 long-term multi-center studies. The company has extensive experience in all areas of clinical trial management, including strategic planning, data collection and analysis, and regulatory filings, including new drug applications in the U.S. and Europe. For additional information please visit www.prometrika.com <http://www.prometrika.com/> .