Akcelis specializes in the recruitment of patients for clinical trials. Its name derives from the verb ‘to accelerate’, as this young company speeds up patient registration with effective tools and digital media. And ‘accelerating’ things is exactly what QbD did for Akcelis. Within a month, we helped to optimize their quality system and got various procedures up and running. Across borders, QbD-colleagues from various fields of expertise pulled out all the stops to get the job done.
Akcelis was founded by Nathalie Niclaus and Barbara D’haene, who both have a wide experience in healthcare and biotech. To accelerate biomedical research, they decided to take patient recruitment strategies a step further. They developed C-Lys, a platform that encourages patients to register for clinical trials, while providing ample information on such trials. Effective social media campaigns and online ads direct traffic to C-Lys.
Setting up a quality system in close cooperation
Michiel Hertegonne (QbD Business Development Manager) had the first contacts with Akcelis: “Nathalie and Barbara wanted to have C-Lys fully prepared for upcoming projects. That’s why they got QbD on board.” In line with the QbD approach, we started out with a QuickScan. This resulted in two main insights. First, our expertise could help to further optimize Akcelis’ quality system. Secondly, C-Lys had to be validated: something their customers – mainly pharmaceutical companies – would require from Akcelis.
To take Akcelis’ quality system a step further, QbD gave tailored advice to improve various procedures – from document management to change control. This way, QbD helped to ensure that these procedures were not only thoroughly defined but also implemented on time. “We worked in close cooperation with Akcelis, giving them specialized advice, which they used to further develop their quality system. We ensured a handover of all necessary knowledge, which they now apply to manage their quality system autonomously”, says Martijn Reniers (QbD Managing Partner).
24/7 progress thanks to QbD Mexico
Validating C-Lys was another challenge. The application needed to comply with various privacy and legal requirements. Moreover, the validation process needed to be performed within a short timeframe. Yves Dène (CSV Lead at QbD): “To ensure timely delivery, we worked together with our colleagues at QbD Mexico, who did an excellent job. The time difference came in handy: while we were sleeping in Europe, they created the validation deliverables.”
Barbara D’haene (Akcelis): “The software validation of C-Lys went smoothly. Yves provided us with valuable knowledge and installed various procedures, so that we can manage efficient change control processes in the future.”
All in one month
As a result, QbD helped to fine-tune Akcelis’ quality system, and have their application fully validated – all within one month. Martijn Reniers: “This project truly involved all corners of QbD and a high degree of integration – different teams, specializations and countries. It also reflects our true team spirit and integrated approach: many companies say they have it, but we really do it.”
Overall, QbD can look back on a pleasant and open collaboration with Akcelis. Yves Dène: “Now that the quality system is optimized and the validation has been delivered, we are still in touch with Akcelis for advice whenever they need it. You might say that we partially fulfill the role of an external quality assurance department. It might even become a more ‘full-circle QbD project’, if QbD Software would get involved in the future. We are looking forward to that.”
Nathalie Niclaus (Akcelis): “As Akcelis has a strong focus on quality care, QbD is the ideal partner to realize our ambitions. Thanks to its unmatched expertise, QbD ensures fast and efficient project deliveries. Thank you for the inspiring collaboration!”