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inVentiv Health - Leading Provider of Global Drug Development Services to the Biopharmaceutical Industry White Papers

inVentiv Health - Leading Provider of Global Drug Development Services to the Biopharmaceutical Industry

Top Nine Opportunites for Improving Observational Research We recently received a Request for Proposal (RFP) from a large pharmaceutical company for an Observational Study to be conducted over the course of five years in several countries worldwide, involving hundreds of sites and thousands of patients. The RFP included a brief synopsis of the project and described how subjects would be randomized to one of two primary study arms in which they would be required to visit participating physician sites through a fixed schedule of follow-up visits. A detailed grid was included for us to complete seeking our proposed budget for, among other activities, a pre-determined number of monitoring visits.
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Oncology Fact Sheet The unique patient populations, study design challenges, and special endpoints associated with oncology trials demand specialized knowledge. inVentiv Health Clinical’s team, comprised of experts who are dedicated to oncology research, is uniquely qualified to manage that complexity. Our experience spans many indications, interventions, and phases of oncology drug development. We apply our therapeutic expertise to address the unique challenges of oncology research—and help get critically needed products to market faster.
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Non - GLP Services Overview Fact Sheet inVentiv Health Clinical provides high quality bioanalytical services across the continuum of drug development. With more than 100 dedicated scientific professionals with experience developing more than 1000 methods, we can provide consistently high quality performance and service for any bioanalytical project. Our two GLP-compliant facilities house more than 60 LC-MS/MS, 13 GC-MS/MS, and 20 robotic units, giving us one of the highest capacities in the industry. This flexible capacity, with our rapid data handling capabilities, keeps studies on track and timelines under control.
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Large Molecule Fact Sheet inVentiv Health Clinical provides a full range of services needed to drive your large molecule development programs forward quickly and smoothly from discovery through post-marketing.
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505(b)(2) Services Extending the life of a therapeutic can substantially enhance its value. The 505(b)(2) approval route was designed to encourage innovation, extend the life of a product, and provide an opportunity for market exclusivity, while minimizing the time and cost required for traditional clinical studies. For some products, the reference drugs can be relied upon for the safety and efficacy information (non-clinical and clinical), with some additional work required to establish comparability.
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