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What 30 years in clinical data management have taught me
By Luc Braeken, Director Biometrics, SGS
By Luc Braeken, Director Biometrics, SGS
Over the past 30 years, our clinical data management team has grown from a start-up idea in an attic into a trusted partner for pharmaceutical and biotech companies across Europe and North America. What is the secret behind our lasting relevance in a rapidly evolving industry?
We have seen processes transform, technologies evolve and operating models shift. But through all of it, one thing has stayed the same – the people.
At SGS, loyalty is not a buzzword. Many of our team members have been with us for decades, and most of our leadership has more than 20 years of experience at SGS. That kind of continuity is rare today. It fosters trust, supports deep expertise and strengthens long-term relationships with clients.
This stability also allows us to invest in training, mentorship and internal growth. With more than 300 highly trained professionals who have developed alongside the company, we have built a strong, in-house knowledge base.
Structured training plans, an online learning platform, buddy mentoring and dedicated onboarding teams help new team members build confidence quickly. As a result, junior colleagues are able to deliver senior-level work much sooner than expected.
It has strategic value. In an industry where staffing models are constantly shifting, having a stable, experienced core allows us to bring new colleagues up to speed faster and transfer knowledge more effectively.
While remote and decentralized work have become the norm across the industry, we have made a deliberate choice to co-locate our data management and data programming teams. Everything we do – from eCRF design and SDTM programming to data cleaning and biostatistical analysis – happens under one roof.
When people work in the same space, communication becomes faster, decision-making more agile and cross-functional learning more natural.
As much as we embrace technology, there is still no substitute for turning around and having a quick conversation. We share the same coffee machine, and that continues to shape the way we collaborate. That familiarity makes a difference.
Operating from a central European location may not always win on price – but we make up for it in efficiency, speed and precision. Our teams are used to working with clients across time zones, adjusting schedules without compromising work-life balance or project timelines.
I remember a challenge with a biotech client where we had to implement a major change late in the process, impacting the study analysis. The team worked weekends, adapted documents and updated programming. What no one expected was accomplished – we met every deadline, and the client reached their critical company milestone. That was not just planning. That was people stepping up for each other.
This adaptability and expertise are key reasons why clients often re-engage with our team when they change companies. In many cases, we are brought along. That kind of loyalty speaks volumes.
Over the past 30 years, we have moved from paper case report forms (CRF) stored in filing cabinets to electronic CRF systems that are built and ready before the first patient visit. We have embraced the shift from paper to digital and continue to invest 25 percent of our resources in process improvements. But we approach innovation with intention.
One of our latest initiatives, Project CLAIRE, brings together a cross-functional taskforce to explore how AI can responsibly accelerate clinical data work.
AI has enormous potential, but we operate in clinical research, not consumer tech. That means validation, safeguards and human oversight are essential. The hype does not drive us. Clinical integrity does.
The clinical trial landscape continues to accelerate — more data, more complexity, more automation, more urgency. We have seen outsourcing trends come and go, and come back again. Whether we are supporting clients on-site or remotely, we adapt.
Right now, we are seeing a renewed interest in insourcing. Some clients are scaling back internal teams and relying on external experts they can trust. They need teams who can step in quickly and deliver with consistency.
After three decades in the field, my takeaway is simple: processes change. Tools evolve. But what really carries a project through complexity is people – committed people. They are the foundation of quality, trust and impact.
Over time, the growth of our clinical data management capabilities has enabled us to evolve into a full biometrics functional service provider. Today, we bring eCRF design, eTMF, data programming, biostatistics, medical writing, project management, and pharmacovigilance and medical monitoring together under one roof – enabling seamless collaboration and consistent quality.
Curious how our approach to data management could support your next study? Let’s start a conversation.
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).
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