Outsourcing

Articles

From product development to finished patient kits, Rockwell Automation equipment is used throughout the entire process.

Global Pharmaceutical company implements clinical trial management solution

The author examines the use and advantages of disposable technologies in the fill–finish of sterile pharmaceutical products and how these technologies can reduce costs and time in producing clinical-trial materials.

Disposable Technologies for Fill-Finish of Clinical-Trial Materials

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

CROs and CMOs expand to gain a piece of the market for clinical trial materials.

Outsourcing Clinical Trial Materials

Sylvia Findlay is Pharmaceuticals and Biotechnology Industry Analyst at Frost & Sullivan.

The CRO market is experiencing two-tiered growth: firstly from pharmaceutical companies seeking to lower fixed costs by outsourcing clinical research to CROs; and secondly, from biotechnology and specialty pharmaceutical companies that lack the infrastructure to conduct trials.

Outsourcing clinical trials: growth continues

Jim Miller is president of PharmSource Information Services, Inc., and publisher of Bio/Pharmaceutical Outsourcing Report.

CMC service providers are doing well, but clinical and preclinical CROs are doing even better.

Clinical Outsourcing Steams Ahead

The outsourcing of clinical-trial materials grows as pharmaceutical companies adapt to a changing market.

Outsourcing Clinical-Trial Materials Heats Up

The authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.

Scale-up trials of foam-granulation technology — high shear

This article is written to assist clinical manufacturing representatives at pharmaceutical companies who are faced for the first time with outsourcing the manufacture of clinical supplies. The author describes the identification, writing, and execution of documents required to support the contract manufacture of products for clinical studies.

Contract Research Services