Jan Balemans, Founder and Managing Director and Wanda Meijst, Director Clinical Operations
A biotechnology and clinical research veteran, Jan Balemans, realized the dire need to change the way CROs operate and comply with the regulations. He not only ideated the foundation of a CRO that stands apart from the compeers but also founded one. As the helmsman of Siron BV, a clinical research services company, Balemans leads an international team of experienced senior clinical research associates (CRAs) who specialize in conducting complex clinical trials in a variety of indications, including orphan diseases, pediatric studies and oncology. With the guidance and active participation of Siron BV, small to medium sized biotech companies successfully complete the clinical trials and ace the regulatory requirements across different geographies.
Siron BV’s pursuit for clinical research excellence begins with the requirement analysis, followed by site identification and feasibility visit followed by regulatory and ethics submissions. Once the regulatory and ethics approvals as well as budget and contract negotiation are in place, the company performs site initiation and monitoring by assigning its team of CRAs, and trains the study teams how to conduct the clinical study. Siron BV also formulates the site recruitment strategy and offers interim site monitoring as a part of site operations monitoring. Their engagement strategy simplifies documentation of the entire journey of the clinical research process.
In addition to fostering agility to meet client’s varying demands, Siron BV focuses on appointing the highly experienced clinical research professionals and making them a part of client’s business growth. These qualified resources individually, having more then 15 years of experience in clinical operations and regulatory, perform quality control for clinical study through numerous procedures. Wanda Meijst, Director Clinical Operations at Siron BV adds, “We offer clinical study document review and accompanied site visit.”
Our team simplifies conducting clinical trials across different geographies and guides the clients acing the regulatory requirements
The company’s QA/QC officer independently checks for completeness and accuracy of the studies files in accordance with SOPs, guidelines, and regulations. The officer visits the site and assesses the monitor and study teams for site management and adherence to pre-defined procedures. Additionally, the firm determines the inspection readiness for the regulatory audits, confirms the integrity of the clinical data, and communicates the inadequacies in complying with various guidelines and maintaining quality standards.
As biotech/life sciences companies may run several clinical projects simultaneously, project management emerges as one of the major challenges. Here, Siron BV plays a crucial role in ironing out the intricacies in project management. The firm manages the resources by coordinating and tracking project activities. Siron BV also liaises between sponsor and project team, communicates the trial progress, and also enforces the project timelines and expedites the application of knowledge.
With its experience and expertise in clinical research services, Siron BV has handsomely tackled the regulatory challenges and operational hurdles for its numerous clients. For instance, a small U.S.-based client had to conduct a clinical study in Europe and other parts of the world. After collaborating with Siron BV for feasibility and site selection, in the disease indication, the client could operate smoothly within the European regulatory framework. The success of the phase 2 clinical study encouraged the client to continue the collaboration with Siron BV for conducting the next phase in more countries across Europe. Eventually, the client could complete the clinical trials and received FDA and EMA market approval after successfully passing inspections.
Siron BV aims to grow its footprint across Europe and other parts of the world through partnerships and plans to extend its services like data management and medical writing through collaborations. With deep knowhow of complexities and nuances in domestic and international clinical research environment, the firm is set to tap growth opportunities.