Technical Resources International, Inc. (TRI) and its subcontractor Nuventra Pharma Sciences (Nuventra) have been awarded the Pharmacokinetic Analysis Resource Center contract by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). The contract has a potential total value of up to $2,676,503 over 5 years.
Under the contract, TRI and Nuventra will provide NIDA with support for protocol development; clinical study monitoring to assure Food and Drug Administration (FDA) regulations are met; data management; pharmacokinetic (PK), pharmacodynamic (PD), population PK and statistical analyses; and preparation of clinical study reports. The data and reports will be submitted to the FDA in support of Investigational New Drugs (INDs) and New Drug Applications (NDAs).
A major mission of NIDA is to develop new medications for the treatment of substance use disorders. Medication development involves the design of new drugs, preclinical evaluations, pharmaceutical development, and clinical evaluations. A critical aspect of clinical evaluations involves the determination of PK and PD of new medications under development.
Commenting on the contract award, Nora Lee, TRI’s President and CEO expressed, “TRI is pleased to have established a successful team with Nuventra to support NIDA’s mission.” Alexander Shaw, Nuventra’s COO added, “We are excited about this long-term partnership with both TRI and NIDA. This successful venture with TRI is yet another example of how Nuventra is providing comprehensive pharmacokinetic and clinical pharmacologic services to today’s drug development industry while maintaining ease-of-access and simplicity for our clients.”
Technical Resources International, Inc. is a full-service contract research organization plus (CRO+). TRI’s areas of expertise include clinical trials management, regulatory affairs, medical writing, safety & pharmacovigilance, data management & biostatistics, quality assurance, information technology, toxicovigilance, and health assessment. In addition, TRI offers health communication services such as multi-level event planning and execution, design and implementation of marketing and outreach campaigns, multimedia design, focus groups, surveys, trainings, and product launches. For more than 34 years, TRI has provided support to government agencies, the private sector, and non-profit organizations. Further information is available here.