ABSTRACT
Where to start Other chapters so far have made it clear that writing and maintaining SOPs is an ongoing project for every company, but where do you start when you are a new company just getting going with running clinical trials? After you write an SOP of SOPs, then what SOPs have to be written first and what do you do if you have to start trials without a full set of SOPs? This chapter provides some approaches for one common growth path for new companies: starting out as a virtual corporation with most of the study work contracted out and then bringing more and more trial activities in-house over time.
