PharmaLinkFHI Receives ISO 9001:2000 Quality Certification of CRO Services
PharmaLinkFHI, Inc. (PharmaLink) today announced that its facility has been Registered by Underwriters Laboratories Inc. to the International Organization for Standardization ISO 9001:2000 Series Standards for Quality. PharmaLink is a full-service Clinical Research Organization (CRO) that leverages industry leading web-based technologies, integrated cross-functional teams and proprietary eClinical tools to provide high efficiency clinical research services to biopharmaceutical companies. PharmaLink is one of very few CROs to have achieved the distinguished ISO 9001:2000 quality system registration.
This is an important step in PharmaLink’s efforts to establish a new paradigm for the conduct of clinical trials. PharmaLink was built from the ground up as the first electronic Clinical Research Organization (eCRO), and has provided clinical research services for all phases of the drug development process. Commenting on the achievement, PharmaLink’s CEO, Dr. Al Siemens said “The objective has always been to provide a higher quality of service to our customers, and this is made possible by a transparent, electronically-supported clinical research model that allows real-time access to information for improved trial management and decision making.” PharmaLink’s revolutionary eClinical approach required the organization to identify appropriate technology tools, redefine research processes to fully leverage the potential of web-based trial conduct, and redefine personnel roles and training. Dr. Siemens continues, “Electronic data capture (EDC) has held much promise, but it is less about the EDC tools and more about how an organization works with those tools to deliver on their potential.”
Recognizing that effective implementation of these tools and processes are critical to the delivery of a high quality service product, PharmaLink established a Quality Management System (QMS) to ensure conformance to quality standards. It is the QMS system that was reviewed and certified as ISO 9001:2000 compliant by Underwriters Laboratories Inc. Elaine Wingate, Executive Vice President Quality Assurance and Regulatory Affairs states “The ISO Certification is a major independent endorsement of the high quality services provided by this organization for our pharmaceutical, biotech and medical device clients. The achievement of ISO 9001:2000 registration represents a significant milestone in the evolution of PharmaLink and implementation of our quality management system. The quality system defines our processes in a consistent way, provides the framework to measure and improve upon what we do, and enables us to provide consistent quality deliverables time after time. All of these factors ultimately lead to improving customer satisfaction.”
About PharmaLinkFHI
PharmaLink is a new breed of clinical research organization managing Phase I-IV clinical trials and post-marketing programs online in real time. From protocol development through final clinical study report, PharmaLink integrates deep clinical know-how with industry leading technologies, engaging the entire clinical team with actionable intelligence for more confident decision-making and risk management. Biopharmaceutical and device manufacturers look to PharmaLink’s proven approach to support and streamline the product development process. For more information on PharmaLink, visit our web site at www.pharmalinkfhi.com
