Similarities between Taxes and TMF


In honor of tax day in the United States, I thought I would outline the four ways that trial master file (TMF) management is like doing your taxes. Both are required Both require vast amounts of information and documentation Both have dedicated experts Technology can make both easier TMF Management and Taxes are both required … Read more

Clinical 101 – TMF Basics

Why do organizations maintain a TMF? When I was consulting, I was often asked why we had so many projects helping clients improve their Trial Master File (TMF) management abilities. While I like the think that there was so much demand for Electronic Trial Master File (eTMF) consulting because people genuinely are excited about eTMF, … Read more

How to choose a TMF services partner

Now that you have chosen an eTMF for your organization (hopefully following the advice in my post about how to choose the best eTMF system,) you are probably beginning to envision how your team will use the new system to drive improved inspection readiness for your organization. During this phase of the transition to a … Read more

How to choose the right eTMF

Over the next few paragraphs, I will provide guidance on how to choose the right eTMF for your organization based on my almost 10 years of consulting on eTMF. I helped dozens of organizations improve their trial master file (TMF) management capabilities during my time consulting for life sciences organizations. While each of these organizations … Read more

What is business architecture?


The other day I was talking to a friend of mine who had looked at my LinkedIn profile and noticed that I had listed business architecture as a skill/job of mine. He had never heard of this discipline and jokingly asked if I design businesses. My gut reaction was to say “Of course not”, but … Read more