MDS Pharma Services adopts EP Series from InnaPhase to speed early drug development services
The EP Series is an enterprise technology solution for data management and analysis, designed to consolidate early drug development data and comply with FDA guidelines on electronic records and signatures (21 CFR Part 11). Created by InnaPhase, the EP Series manages pharmacokinetic (PK) data (how the body absorbs and metabolizes drugs) and pharmacodynamic (PD) data (the drug's effect on the body). EP2 is the only protocol-driven system available for managing early development data, and provides extensive data analysis and reporting capabilities that expedite early drug development processes.
"Our key objectives were to find a solution that would comply with FDA's Part 11 regulations and offer a high level of scientific flexibility, while allowing us to process our clients' projects more rapidly," said Dr. Jerry Merritt, senior vice president, early clinical research, MDS Pharma Services. "With InnaPhase's Watson LIMS system in our bioanalytical laboratories and EP2 in our pharmacokinetics group, we will be able to completely integrate our operations and provide unparalleled accuracy and efficiency and rapid turnaround of study data and results. "
"We evaluated several alternatives, but no others offered the level of regulatory compliance and report automation that EP2 provides," commented Paul Cordeiro, project manager, MDS Pharma Services. "EP2 is flexible enough to allow us to meet our internal needs and those of our clients. Such technology and unmatched expertise allows us to develop seamless drug development processes."
"We are very excited about our continuing global technology relationship with MDS Pharma Services," said Peter J.D. Ryan, chief executive officer, InnaPhase Corporation. "MDS Pharma Services has taken a leading position by quickly recognizing the value of integrating InnaPhase's EP2 and Watson LIMS systems, forming an end-to-end solution for managing and reporting both bioanalytical and PK/PD data. Our additional validation services will permit MDS Pharma Services to get the system up and running quicker than any other solution, allowing the company to continue offering more competitive services to their customers."
InnaPhase Corporation is a worldwide leader in software technology for early drug development. Its software solutions are rapidly becoming the industry standard for preclinical and clinical pharmacology and help integrate early drug development data into enterprise-wide knowledge that fosters better decisions, sooner. With 15 years of scientific experience in advanced software and clinical database technologies, InnaPhase provides solutions for more than 800 customers in 45 countries, creating a competitive edge that allows customers to maximize their drug development pipeline. InnaPhase has locations in the United States, Canada, France and the UK. For more information, see InnaPhase on the worldwide web at www.innaphase.com.
MDS Pharma Services offers a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotechnology industries. With facilities in more than 17 countries, the company applies advanced scientific and technological expertise to each stage of the drug discovery and development process: discovery, preclinical, early clinical research (phases I-IIa), bioanalytical, global clinical research (phases IIb-IV), and central lab.
MDS Pharma Services is a part of MDS Inc., an international health and life sciences company. The MDS focus is on using science to advance health, to fight disease. It does this by providing: laboratory testing, imaging agents for nuclear medicine testing, sterilization systems for medical and consumer products, research services to speed discovery and development of new drugs, therapy systems for planning and delivery of cancer treatment, analytical instruments to assist in the development of new drugs, and medical/surgical supplies. MDS employs more than 10,000 highly skilled people at its global operations on five continents. Detailed information about the company is available at www.mdsintl.com or by calling 1-888-MDS-7222, 24 hours a day.
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