My take-aways from the TMF & GCP Inspection Readiness Forum - Arkivum

eTMF & GCP Data / 16 Dec, 2021

My take-aways from the TMF & GCP Inspection Readiness Forum

A few weeks ago, I had the opportunity to attend the TMF & GCP Inspection Readiness Forum and listen to some of the smartest people in our industry share their thoughts across a range of fascinating topics.

There were two talks that really caught my attention and left me thinking about after the conference ended (well – three – but it seems a little self-indulgent reflecting on the talk Russell Joyce and Matthew Addis gave regarding the Practical Approaches to Digital Preservation for TMF and GCP Data).

Embedding cultural change

These past two years have accelerated the uptake of new ways of working and technical solutions within our industry. Fiona MacKenzie (Manager, TMF Operations at Alnylam Pharmaceuticals) chatted about how embedding cultural changes within your organisation can improve your TMF Inspection readiness and provide the foundation for many other projects and benefits.

Fiona’s focus on the renovation of culture being a key part of successful change speaks to everyone who has ever tried to make a change within an organisation.

As the subject matter experts, we’re always trying to exert our passion to peers and colleagues, to get them excited about the changes and for them to hopefully, follow you.

Treating these changes like any other project and building structure to create a roadmap is something often lost when we are concentrating more on cultural changes rather than bringing in new systems or launching a product.

I personally loved the approach taken and the higher-level perspective as the messages shared here can be used for so many things.

Risk-based vendor management

Secondly, the ever-controversial (his words not mine), Eldin Rammell (Head of Quality Assurance at Phlexglobal) shared his thoughts around risk-based vendor management… from the vendor’s perspective.

I have been lucky enough to be both a buyer and seller of clinical trial solutions and so have spent my time both evaluating vendors and being evaluated.

It wasn’t until I moved to the other side that I realised so many of the things Eldin shared to be true. We discuss risk-based so much in our industry – and for good reason. Yet we often forget that it’s not just something that is saved for single parts of our processes.

Maybe we should take a step back and ask, “what is this vendor doing for us?”

As a quick example, refraining from sending every form and document because it is the ‘done thing’ doesn’t just save your vendor’s time, but it also reflects that your organisation has a thought process…and those processes are not just blindly followed.

As a vendor, we’re always happy to speak with customers, share our experience and answer questions. If it matters to you then it matters to us.

But when we receive requests with the message “Sorry, ‘X’ needs this filling out because…” perhaps it’s time for both vendors and sponsors to review processes and concentrate on what truly matters – providing better solutions to patients who need them.

What connected these two for me was not the changes we’ve witnessed in our industry over these last two years but also, the upcoming EU regulation 536/2014 due to come into effect on the 31st January 2022.

To successfully progress into the future will require changes to how we work, as well as new focuses that are going to require bringing teams along and engaging with new vendors. By taking onboard the thoughts and insights shared in these talks will ensure that successful outcomes are more likely for you, your team and your wider organisation.

Thank you again to everyone who shared their time with us at the TMF & GCP Inspection Readiness Forum – hopefully we’ll see you in-person soon.

If you missed out on our presentation at the event, you can catch the recording of Matthew and Russell’s presentation here.

Rob Jones

Rob joined Arkivum in 2021 from Phlexglobal, where he spent nearly 3 years supporting the global sales team in promoting TMF best practice and Phlexglobal’s technology. He has worked across multiple departments such as customer success, delivery and onboarding. He has dedicated his career to the field of Life Sciences and has spent his time working for CRO’s, Sponsors and Technology Vendors.

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