Nicola Lees

WORK HISTORY

ABOUT NICOLA LEES

I am an eClinical Business Systems Analyst and programmer with experience in implementing eClinical systems for the purpose of building an eClinical platform comprising the technology to play a major role in the execution of clinical trials. Medidata RAVE certified study builder and administrator, Veeva eTMF certified administrator. I have worked in the Pharmaceutical industry since the late 90\'s in roles in Data Management and clinical programmer, firstly on paper based studies then on EDC. After building clinical databases for over 13 years, starting with Oracle Clinical, moving onto Medidata RAVE and then InForm using knowledge of the full software development life cycle, and tools I used whilst gaining a qualification in software testing, I am now expanding my technology focus from EDC to look at all technologies that can be used in Clinical Trials. This has began with CTMS and eTMF with the aim of moving to a full eClinical platform from study start up and site selection through to the end of the trial. It is an exciting time to be involved with Clinical Technology with the innovative software being created to help end users make the process easier, whilst adhering to all appropriate regulations. Experience of Phase I, II, and IV trials.