Carol Wiley

Right-sizing a Clinical Compliance Program

Right-sizing a clinical compliance program in a small pharmaceutical company requires careful consideration and strategic planning. While the specific details will depend on the size and nature of your organization, there are some general steps to help you right-size your clinical compliance program. Start with the basics by familiarizing yourself with the applicable regulations and […]

An Inspection Ready versus Inspection Prepared TMF

I am so ready for a vacation! How many of us have said that daily – ready for and desperately needing a getaway. It is easy to say we are ready for vacation, but would we be prepared for a vacation if it was offered on short notice? Being ready and excited for a vacation […]

Managing the Impact of Systems Updated

Managing the Impact of eClinical System Updates Many of us use cloud-based clinical systems that regularly release system updates.  Sometimes these are optional updates and sometimes they are required.  System updates do everything from fixing bugs to offering enhanced capabilities.  Often organizations go through the motions of accepting these updates without considering the implication of […]