All things eTMF with Petek Berker Birik

Excelya>All things eTMF with Petek Berker Birik
all things eTMF, Petek Berker Birik

Today we will hear from Project Director and specialist in all things eTMF, Petek Berker Birik, who is based in Excelya’s Istanbul office.

Petek has been a part of the Excelya team for over 6 years now and has worked in the CRO business for more than 22 years. She is the main point of contact for eTMF clients and partners and is responsible for all eTMF commercial assignments within the Excelya Group.


The world has become a much smaller place thanks to technology.

Instead of crossing countries to have meetings with colleagues, or attending conferences around the globe, colleagues are just a click away… we can connect via social media and can safely and efficiently share data electronically.

Changes in the way we work

During the COVID-19 pandemic, I was able to continue all my personal responsibilities, and all our clinical trials were able to be conducted remotely, partially thanks to eTMF technology.

Based in Istanbul, I cross 2 continents (Asia to Europe and back again) during my commute to the office. The new post-COVID strategy of having a hybrid telework and physical office presence will mean less time commuting, and more time taking advantage of the freedom and efficiency that tech brings.

Not so long ago, this would not have been possible!

An ever-evolving landscape

Working in the CRO and data handling business as long as I have, you get used to seeing things change.

In the early 2000s, clinical trials would take much longer, as CRAs would have to physically go to the site to get the paperwork, travel between sites, send multiple faxes, etc., before a database could be built, and the information analysed. When I started out as a CRA, all my record-keeping and trial notes were paper based.

Paper-based data collection encountered a digital revolution around the turn of 2010, and things such as GDPR and digitization continues to see the landscape changing.

It doesn’t bear thinking about how impacted our lives would be if we had faced a pandemic during those times…

A boost in quality and efficiency

Not only was it more precarious, but a lot of time was also lost this way. Now data is one click away, and by using an eTMF provider we also intercept and prevent a lot of human error. Data is also kept under digital lock and key.

It’s revolutionary for sponsors to be able to access their data in real time. Hypotheses can be drawn; decisions can be made more quickly – not to mention the ease of storing data much more safely.

Technology has changed a lot in the past 20 years, and it continues to shape what is possible in the world of clinical trials. The digitalization of the data collection process makes clinical trials more cost effective, with higher quality of data.

Global collaboration

I work closely with our eTMF hub in Greece, but thanks to technology I can link up with them digitally every day without crossing the countries.

That said, I enjoy the travel aspect of my work very much, but I really appreciate how digital (and cultural!) advances in recent years have made face-to-face meetings much less frequent. It’s much safer during these complicated times, more convenient, and of course, much more eco-friendly. Still, I take every opportunity to visit my eTMF colleagues in Greece.

The future of eTMF & Excelya

Speaking of seeing things change, it has been exciting watching Excelya evolve during my time here.

I have witnessed the company grow from a mid-sized French start-up to a flourishing Pan-European business, going on to open offices in India and the UK, and now setting our horizons even further.

The future is virtual!

Working closely with Alan Morgan, our CEO, I am determined to do my part to drive eTMF forward as an essential and integral part of Excelya’s future vision. We aim to stay at the forefront of innovation, and by forming partnerships with industry-leading partnerships such as Veeva Vault, we are setting Excelya on the path to continued eTMF success.