SAS will facilitate data from health care providers and hospitals in its Drug Development environment for collaborative data analysis. Here’s the announcement. “Strong and efficient interfaces that link electronic health records with the pharmaceutical industry and regulatory authorities will enhance public health by improving both therapeutic product safety and efficacy,” said Edward Helton, PhD, SAS’ chief strategist of regulatory and biomedical Affairs.
Parexel International, a global bio/pharmaceutical services organization, is helping customers take a proactive approach to drug safety and risk management with a more unified packaging of its pharmacovigilance services. Customers have access to a global network of Parexel experts who can help weave the appropriate safety and risk management measures throughout the drug development process. The experts include safety physicians, scientists, and pharmaco-epidemiologists as well as consultants that bring regulatory experience from leading health authorities, such as the FDA or the MHRA. Services include adverse event management, regulatory reporting, design and maintenance of global safety databases, coding, trend analysis, and risk management.
Wellquest, a contract research organization (CRO) owned by Nicholas Piramal India (NPIL) recently opened its second clinical research facility in Hyderabad, India. The facility is a 112-bed operation and it supports the company’s first female-only ward and a pediatric ward. This site in Hyderabad will conduct only global trials for Phases I-III. NPIL further considers partnerships with Singapore-based firms to enhance research on primate and toxicology studies.
Frontage Laboratories, a provider of bioanalytical, pre-clinical and drug development services to the pharmaceutical industry, announced that it has acquired a significant equity interest in Advanced Biomedical Research (ABR), a full service CRO. With the completion of this initial phase acquisition, the combined resources of Frontage and ABR offer unparalleled formulation development, bioanalytical and GMP testing services, Phase I-II study performance in a state-of-the-art 72-bed clinical research facility, and “turn key” multinational Phase II-IV CRO services. “Years of partnering with Frontage have already proven the synergies of our combined resources and capabilities,” commented Dr. Michael S. Willett, president and chief executive officer of ABR. “Taking advantage of the opportunity to formally add Frontage’s high caliber bioanalytical services and client focused management commitment to ABR’s current offerings of clinical trial conduct and CRO services makes good sense for our respective teams as well as our clients. It will enable us to more fully meet the complete spectrum of our clients’ needs.”
Cedra Clinical Research (Cedra), a CRO, announced recently that it will begin conducting Phase I trials electronically with LabPas CT in August. “We are extremely pleased with LabPas CT,” said Dr. Sherilyn Adcock, vice president and chief science officer at Cedra. “The software and the implementation have exceeded our expectations in terms of functionality. The LabPas team has been great to work with and adaptable to our needs. We look forward to the enhanced quality and efficiency that will result from conducting our Phase I trials electronically.” Cedra is one of seven clinical research organizations to have selected LabPas CT in the past year. LabPas CT, a software solution for Phase I clinical trials, improves margins, decreases liability and increases clinical capabilities. It comprehensively manages Phase I clinical trials, from recruiting through export to EDC.
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