Clinical Services

At B+solutions, we provide comprehensive Clinical Services to support every phase of the medical device clinical lifecycle, from trial design to post-market surveillance. Our expertise in clinical research ensures that your studies meet regulatory standards and generate the necessary evidence for market approval. We offer tailored solutions in the following areas:
• Clinical Trial Design, Management, and Monitoring: We design clinical trials that align with regulatory requirements, manage the logistics of your studies, and provide ongoing monitoring to ensure compliance and data integrity.
• Clinical Research Coordination and Site Management: Our team supports the coordination of clinical research activities and site management to facilitate smooth trial execution and reliable data collection.
• Data Management and Biostatistics: We offer robust data management solutions and biostatistical support to analyze clinical data, ensuring accurate results and informed decision-making.
• Medical Writing and Publication Support: We assist with the preparation of clinical study documentation, including protocols, clinical study reports, and manuscripts for publication.
• Clinical Evaluation Report (CER) Development: Our experts prepare comprehensive CERs to demonstrate the clinical safety and performance of your medical devices, in compliance with EU MDR requirements.
• Post-Market Surveillance and Study Management: We help you implement and manage post-market clinical follow-up studies to continuously assess device performance and safety.
• Clinical Investigation Planning and Execution: We provide support throughout the entire clinical investigation process, from planning to execution, ensuring your studies meet regulatory and ethical standards.
• Clinical Trial Application (CTA) Submission: Our team prepares and submits CTAs, enabling you to start clinical trials in compliance with regulatory requirements.
B+solutions is committed to guiding your clinical projects to success, providing the expertise and support needed to navigate the regulatory landscape and bring safe, effective medical devices to market.