Blog Posts

Great Britain’s MHRA (Medicines and Healthcare products Regulatory Agency) is known (and feared) for their high expectations regarding the TMF. MHRA expects your TMF to be “the story of how the trial was conducted and managed.” Their “inspectors want to reconstruct the trial conduct so that it can be evaluated for compliance …[and] review any…

“No-one goes to work to do a bad job!” This quote, penned by legendary management thinker W. Edwards Deming, was introduced to us by a friend of LMK, process improvement and human factors guru, Keith Dorricott. In a recent LMK webinar, Keith discussed best practices for TMF metrics, and arrived at the conclusion that this…

Is your TMF ready for GDPR? This is the third and final post of a series examining how the new European Union General Data Protection Regulation could affect your trial master file. See part one and part two which examine the basic roles within GDPR and the foundational rights of data subjects. Serious Penalties and…

Regulation, more than just stipulating what must be done, must also define whose job it is to complete the task. The assignment of responsibility within the regulatory framework surrounding the clinical trial is essential to protecting the well-being of subjects and the validity of the trial’s data. Clear demarcation of the primary roles of sponsor…

Is your TMF ready for GDPR? This post is the second article in a three-part series examining how the new European Union General Data Protection Regulation could affect your Trial Master File. In our last post on the European Union General Data Protection Regulation (GDPR) we examined the primary roles found within the regulatory framework…

This post is the first in a two-part series outlining how the new European Union General Data Protection regulation could impact your Trial Master File. Since 1995, EU Directive 95/46/EC has provided the foundation for “the protection of individuals with regard to the processing of personal data and on the free movement of such data”.…

Elon Musk decided to test his revolutionary Falcon Heavy rocket with the “silliest thing we can imagine”. Usually test payloads for new rockets are made of boring hunks of steel and concrete, but if Elon’s past actions are any indication –see his Boring Company branded flamethrower— normal just wouldn’t do. So Musk tweeted out this…