Pharmaceutical and biotechnology companies are finding new innovative approaches to partnering with clinical research organizations (CROs) in order to add expertise to their internal team. In particular, smaller firms are collaborating with CROs in an effort to gain efficiency and cost effectiveness.1 Typically, smaller firms have outsourced a higher proportion of their total clinical research portfolio in order to obtain expertise that falls outside the scope of their core capabilities.2 Successful CRO partnerships can enhance the clinical development process and drug development companies recognize that speed-to-market is essential to gain advantage over their competitors.
One particular area where smaller firms typically depend on CROs is with Common Technical Document (CTD) development. Regulatory submissions are fraught with obstacles to meeting the submission deadlines, but challenges can be anticipated and creative solutions implemented to ensure success. A CRO's experiences with previous regulatory submissions provides historical knowledge of potential pitfalls while offering the sponsor quick resolution to unforeseen barriers (Figure 1).
The first step of the partnership is to clearly define the study-specific information and scope of work between the CRO and the sponsor. This can be easily accomplished using a detailed questionnaire that captures relevant information from each study that will be included in the CTD submission.
For More information please click here: Applied Clinical Trials: Common Technical Document Development - Mary Jane Lunsford & Thomas Kalfas
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