Clinical development plan technology

Regulatory considerations impact the types of data required and production process technologies that must be in place prior to initiating clinical trials. There are three considerations that have significant impact on the preclinical development plan the extent of cellular manipulation, relationship between cell source and application, and scaffold characteristics. Table 35.4 summarizes some regulatory considerations for cellular and scaffold components. 

It is interesting to note how PV and quality assurance (QA) have expanded to include not only technology transfer but also some of the development activity namely, PV associated with clinical supplies production. Another factor that has influenced the need to validate the manufacturing process is the involvement of the contractor, whose site has become the primary or alternate location for the sponsor to manufacture the clinical or commercial product. With this expansion it was inevitable that organizations would formalize the master validation plan as a building block of TQM. Furthermore, it is appropriate to include the validation plan for each clinical production process in the master validation plan. 

Assessing clinical and quality requirements of the proposed program also means planning for how to comply with these standards. Compliance should be considered both on an initial basis and over the long term. Clinical and quality requirements may necessitate the hiring of certain (qualified) staff, the development of work processes to monitor quality, and the implementation of technology or procedures to ensure compliance. 

Information technologies are themselves sufficiently complex and diverse that it is wise to develop a specific strategic plan for information technologies that best serve the needs of the organization. Typically, such a plan should address particular organizational unit requirements, including both administrative and clinical, and the data links and relationships that exist between them. 

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