A "fat" development plan refers to one that has an excessive number of clinical trials, whereas a "lean" one is the opposite. These terms can also be applied to the amount of data collected in an individual clinical trial and also the amount of data collected on an individual patient.

Keep all SOPs up-to-date and ensure that they cover relevant topics for the company. Consider having staff read them every two years and to sign a document attesting to that fact.

To minimize the time and cost of screen failures do the screening in separate stages. First, ask the most important questions to "qualify" patients to be screened, such as during a telephone call. Second, conduct the initial easy to conduct tests and procedures necessary to ensure they are able to pass most inclusion criteria. If one needs to have a third stage then separate the expensive tests/procedures from the less expensive ones and only conduct the expensive ones in patients who have successfully passed the less expensive ones.

It is often useful to ask: "What does that mean?" particularly if you are unsure of the meaning. The person may mention something that you definitely do or do not agree with, but hopefully better understand.