September 17th marks World Patient Safety Day, an initiative created by the WHO to bring awareness to the safety of patients all around the world. As a clinical laboratory whose mission is to help shape and advance clinical trials and ultimately improve patients’ lives, their safety lies at the core of our business. We’re also proud to have directly supported Health Worker safety through our various COVID-19 testing projects across the world and support the WHO’s slogan of “Safe health workers, Safe patients’.
So, how as a leading, global clinical trial laboratory service provider, do we put patients first on a daily basis?
Every employee at Cerba Research, no matter the job function, completes the Good Clinical (Laboratory) Practice training. We ensure our entire organization is, aware of our responsibilities regarding the conduct of clinical trials in order to meet GCP’s objective; ensuring that the rights, safety and well-being of human subjects are protected. This is also reinforced in our company culture whereby patient safety supports our core values and mission.
While perhaps not the most obvious in terms of patient safety, data security is paramount to the well-being of patients in clinical trials. It is vital to secure the privacy of subjects, to guarantee that people cannot be identified based on the samples and (medical) data. Similar to our GCP training, all employees attend mandatory training on data security and GDPR compliance. Further still, our CISO and DSO ensure that our IT infrastructure remains secure and that we have the appropriate systems and checks in place to maintain data security at all times.
Sites and Sample Collection
As a clinical trial laboratory, we have a fundamental role to play in patient safety as the data we produce are critical to health care decisions that will be made affecting diagnosis or treatment. Any analytical or diagnostic error therefore has the potentially to significantly affect patient safety and drives our unrelenting focus on quality all the way through our processes.
These processes begin even before any samples are taken, whereby careful measures are taken to minimize discomfort and pain for the subjects and guarantee the health worker’s safety. Our in-house kit-building team and project management team are instrumental in this. Through them, the sites receive both instructions on how to take samples and the necessary equipment to do so thus creating an informed and protected environment for both.
Through accreditation by the major bodies, we ensure that testing is always done to the highest standards, ensuring accuracy and reproducibility of results. Our deep scientific, technical and operational expertise mitigates any risk during the journey from sampling through to reporting, thus ensuring certainty of results.
Towards the future
Clinical trials continue to evolve, bringing new requirements but always with a focus on the patient to ensure their safety. As 2020 has proven through the COVID-19 pandemic, clinical trials and their processes need to be flexible enough to adapt and overcome unforeseen disruptions. That’s why we are constantly looking for ways to support these new developments, and proactively create solutions that will help support patients’ lives across the globe by enabling them to participate in research in a flexible way that’s centered around them..
The major challenge during the pandemic was the inability of patients or healthcare works to visit sites. Decentralized trials, whereby some or all of the study visit is performed in a patient’s home, is one way around this. Home sampling is therefore an important initiative that we are developing to tackle this obstacle. A combined package of sampling materials and clear instructions that can be sent to the patients themselves, allows them to take their own samples. Guided step-by-step through the process with videos and manuals, patients will no longer need to leave the comfort of their own home in order to participate in trials. Not only does this increase the safety of the patient, it also allows us to involve patients in studies who might have been unable to before. This enables those patients that live in hard-to-reach areas, with little infrastructure, or those who simply do not possess the time or means to go to the collection site, to participate.