A TMF Summit perspective by Paragon's Chris McSpiritt on the recent 6th Trial Master File Summit held in Orlando, Florida, Jan. 17-19, 2017.
I recently had the opportunity to travel from Philly to attend the TMF Summit in Orlando and besides the weather, the one thing that stuck out to me was the focus on metrics and how organizations can leverage them to improve their TMF management.
The organizers of the conference recognized industry trends and demands so they created an entire track of sessions dedicated to metrics and quality. This demand reflects what I am seeing from the industry and from my clients who are working to improve their TMF management practices.
Why care about metrics?
Organizations care about metrics because they give them the ability to evaluate how their processes are working and determine how they can improve them. While many organizations have long relied on qualitative operations/process feedback to guide their process improvement efforts, we are seeing much more focus on leveraging quantitative information to evaluate, improve, and then re-assess operations.
Why the trend?
While TMF metrics apply to all technology landscapes, the increase of penetration of eTMF systems has jump-started TMF metrics programs due to the ease in which one can gather more detailed and real-time information. The major eTMF vendors all include a plethora of reports that support metrics programs and this readily available data source has enabled senior leaders to drill into operations.
Additionally, industry consortiums have placed a focus on TMF metrics over the past few years. First, the TMF Reference Model released an inventory of TMF-specific metrics and supporting material on how to deploy metrics in the 2014.
The Metrics Champion Consortium (MCC) has also been working on TMF metrics and has applied their robust metrics-definition methodology to this arena. Between these two efforts, I am convinced that the amount of baseline metrics definitions that exist will satisfy many organizations.
How to implement TMF Metrics
Once your organization makes the decision to implement TMF management metrics, you must follow the following process:
- Identify what you want to improve about your TMF management.
- Inspection Readiness
- Operations Efficiency
- Identify which metrics are required to evaluate your progress towards your goals.
- Inspection Readiness – focus on completeness and quality metrics
- Operations Efficiency – focus on timelines and cycle time metrics
- Determine the data you need to calculate your metrics (note that not all info will come within your eTMF or TMF management group).
- Collect the data and create metrics reports.
- Analyze the results and create a roadmap to improve the relevant processes.
Looking to the future
I look forward to see the continued evolution of TMF metrics and their use by the industry. That is why my team participates in the MCC TMF Metrics working group to bring our client experiences and desires to the group. Additionally, we focus to ensure that all of our clients realize the potential that metrics have to guide their process improvement projects.
Based on the progress the consortiums have made, the support from the eTMF vendors, and the appetite of the industry I expect to see great things for TMF metrics in the coming months/years. I can’t wait to attend the TMF Summit next year, hopefully in sunny Florida again, to see even more focus on metrics and the successes they have brought organizations.
Got a question for Paragon's Chris McSpiritt? Agree with his perspectives on TMF metrics? Did you attend the Trial Master File Summit in Orlanda too? What were your takeaways? Let us know! Share a comment in our Leave a Comment section below!