Since becoming a freelance consultant in 2004, I have been involved with around 50 different projects to improve practices for managing clinical trial records (aka the trial master file or TMF). In many of these, the company concerned had chosen an electronic document management system for TMF management (eTMF) and required my assistance to implement the technology as efficiently and effectively as possible. This involves re-engineering the processes to be aligned with functionality of the technology and implementing various change management activities. The projects were much more complex than this but in a nutshell, that was usually the primary objective (simplified for the purposes of this blog!).
Several months ago, I took a step back and assessed the effectiveness of those projects. In many cases, the changes introduced were not always delivering the results that I expected and it was apparent that the primary reason was the company’s choice of process that was implemented; I never impose a process on a client….. it is always their choice and I do my best to optimise the choice that they have made.
In addition, last year I conducted research across the industry to try to determine how successful companies were at managing their trial master files and if they were struggling, what the root cause was. This research included three workshops that I conducted at industry conferences (DIA, IQPC and ExL-Events), involving almost 100 participants in total. My analysis shows:
- despite efforts to improve processes and adopt best-in-class technology, companies are still not achieving great levels of compliance with regulatory requirements;
- where some success has been achieved, it has usually required significant ongoing expenditure on quality control activities (i.e. high financial cost); and
- improvements in TMF completeness and quality are often only achieved through dependence on constant monitoring of quality and implementing laborious checks.
Does this sound familiar? Is this your experience too? Have you implemented an eTMF but are finding that it is still a real struggle to achieve any significant improvement in TMF quality or completeness without constantly badgering people to conduct their quality reviews?
The good news is that the research I conducted also showed what the solution is….. and VERY clearly! I am very excited to start sharing this with colleagues and helping turn their situation around. I am confident that I have the solution to this puzzle…. and it is not dependent upon spending huge sums of money either!! If you want to be part of this, just give me a call and I’ll be only too pleased to let you in on the secret!