At the time of this study, Galaxy Therapeutics was in a pre-commercialization phase, actively navigating regulatory pathways. Like many MedTech startups, Galaxy Therapeutics faced a familiar tension: while regulatory trials are essential, they are also highly constrained.
To fill this gap, Galaxy launched a real-world study to complement its regulatory research. The study included participating sites across multiple geographies, including the US, Colombia, New Zealand, Spain, and Pakistan.
However, managing data collection across these regions introduced new challenges:
- Technology usage varied widely across hospitals and regions, with differing levels of digital maturity
- Manual processes like handwritten documentation and physical binders were difficult to track and manage remotely
- Galaxy operates as a lean startup without a large, dedicated clinical operations team
“I’m based in Barcelona, the company is based in the United States, and we don’t have an army of people in the clinical department,” Sergi noted. “So anything that wasn’t easy to manage remotely would have been a challenge.”
To navigate these trials, Sergi and his team knew they needed a tool that could coordinate data collection across the globe without adding significant administrative or cost burden.