Project management of small R&D CRO companies

Medicilon is the first CRO company to provide a full set of pre-clinical trial services and our company meet chinese GLP a nd the USA GLP standards at the same time.Our company is the only one China CRO company to build cooperation with the foreign large CRO company.Medicilon provides biology, chemistry and preclinical research,our animal experiment facility has won international assessment of experimental animals and recognition(AAALAC) and chinese food and drug administration GLP certificate,and has reached the United States food and frug administration GLP standard.

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Project management can add value by anticipating and proactively addressing the issues attending regulatory difficulties.

Project management generally can be defined as the process by which a project is initiated, planned, executed, and controlled from a clearly specified scope to successfully meet project objectives. Although basic concepts of project management can be applied universally, a project management team in a contract research organization company is compelled to adjust its approach according to the vast array of inquiries and work awarded from a diverse set of companies within the industry. Firms can be characterized by the product pipeline and the nature of the drugs they are striving to develop. They often are identified as large pharmaceutical corporations or as newly emerging research and development (R&D) organizations or start-up enterprises in either the pharmaceutical or biotechnology arena that tend to be small. Generics companies generally focus on developing drug products that mimic already marketed products and eventually will compete with these products. Generics firms can vary in corporate size and in product pipeline.

The associations created when start-up innovator, biotechnology, or small generics pharmaceutical corporations approach CROs often arise from the internal pressures placed on these smaller firms to match targets comparable with those of their larger counterparts but with substantially fewer resources. From a sponsor's point of view, a CRO's performance usually is held to a higher standard than that of its own internal processes. This scrutiny is justifiable because the work would not be outsourced otherwise. As a result, the relationship with any chosen CRO company has the potential for tremendous added value.

Accordingly, missing targeted milestones, even slightly, in the development of a key product can have serious consequences that vary in severity depending on the size of the sponsor company and its pipeline. For a large corporation, missing the mark may damage a career, whereas a start-up firm may meet its demise.

Using customer feedback and our own experience, the authors identified five areas of focus where the potential for the greatest value and subsequently the greatest risk lies in the relationships between small start-up R&D firms and large CROs. Part I of this article explores the areas of regulatory and scientific expertise. Part II will focus on risk management, joint ventures, and the one-stop shopping paradigm used by many firms in their outsourcing.