Here's To Your eTMF Health

By Michael Smyth

Twenty years ago, when I was employed at a small pharmaceutical company, we'd work every weekend for six months to get our New Drug Application assembled, QA'd, and packaged up to meet the FDA filing date. When the van carrying the completed application finally drove away to deliver the files to Washington, DC, we'd raise a glass of champagne and say "cheers" to a job well done.