TMF Interchange Ahoy! - Arkivum

Best practice approaches / 27 Oct, 2023

TMF Interchange Ahoy!

TMF Interchange Ahoy!

The 2023 CDISC TMF interchange provided two days of topical talks, networking within the sector, and an unexpected pirate theme! This blog will run through some of the highlights I experienced as a first-time attendee and speaker at the CDISC TMF interchange.

The ship sets sail

Once we had all arrived and gathered in the main conference room, we were treated to an opening that I don’t think anyone expected, a pirate singing a TMF themed sea shanty. I couldn’t dream that if I tried, but it certainly summoned the attention of everyone in the room. This then segued into a keynote speaker and panel in the morning which set the tone of the interchange.

The mission statement of this conference was clear from the start, a consistent TMF that is accessible and usable will help all of us who work with TMFs, whatever capacity that may be in.

This conference offered the opportunity for people across the life sciences sector to gather and share approaches and questions about how we can work towards this, this included sharing success stories struggles, and failures. All with the undertone of progress.

A highlight for me was Laura Wiggins from Just in Time GCP who provided a concise overview of the TMF index and how this can be effectively managed without overcomplicating the topic. The TMF index is the tool used to outline where documents should be filed in the TMF, giving explanations for filing levels so that accurate and complete TMFs can be achieved. While a lot of organisations will already be utilising the TMF index, Laura was able to elaborate on how to maximise this usage.

The treasure hunt begins

The conference hall with various vendors provided a buzzing atmosphere where individuals could discuss what types of work they did and who for. This gave a great mix of the larger known companies and smaller operators to share ideas and practices. This was certainly helped along with the inclusion of a pirate-themed treasure hunt where all participants would need to collect each vendor’s highly coveted pirate stamp to complete the hunt and win the treasure.

Arkivum was lucky enough to be one of the Sponsors of this event and I was able to speak to a plethora of people who stopped by our stand. We spoke to a range of people from across the clinical trial ecosystem.

A couple of really interesting learnings for me included discussing metadata provided from legacy systems and how to utilise this when migrating data. It was clear that this was a priority for a few companies who are exporting out of various source systems. This heavily focused on the logistics of how data can get from A to B with the assurance of the data being complete and common issues that can occur.

What would be a pirate’s favourite subject at the TMF conference? Arrrrrrchiving.

While simply attending provided a fountain of knowledge, I was also lucky enough to be presenting on the Friday morning along with one of our current customers, Ashely Avery of Cerevel Therapeutics. We were able to share the journey that led our two companies to work together and what best practices we gained along the way.

We discussed why digital archiving is important to compliance with regulations such as EU regulation 536, alignment to best practice approaches such as ALCOA++ and ensuring the longevity of access to clinical data and records.

What really struck me about Ashley’s part of the presentation was the prioritisation of archiving within Cerevel. The planning started early on in the clinical trial process, in addition to being rigorous and well thought out prior to even approaching vendors.

If you’re interested in reading the full Cerevel Therapeutics case study, we have readable version here.

To summarise, this was a conference of variety, which is what the life sciences sector thrives on. It was a pleasure to attend and participate and I am very much looking forward to the next treasure hunt.



Antonia Witten

Antonia Witten is the Customer Delivery Manager here at Arkivum. Antonia has built a successful track record of onboarding clients into the solution through the use of structured onboarding sessions and helping customers maneuver around any obstacles presented with their data. Previously, Antonia worked as a Data Compliance Co-ordinator at a phase three clinical trial site where she would handle active trial data on a daily basis, ensuring the integrity of the data remained as a high priority.

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