Clinical Services for MedTech
We provide end-to-end services covering each step of a clinical investigation, from First In Human (FIH) to observational registries
Our expertise is particularly strong in medical devices under the new MD and IVD regulations, demonstrating clinical benefit over existing standards. We help medical device manufacturers meet the clinical and performance requirements of the MDR and IVDR through tailored pre-market studies, post-market clinical plans and real-world data collection programs. These efforts are aimed at securing regulatory approvals and maintaining CE Marking by generating robust clinical data to support device safety and performance.
We provide comprehensive CRO services and clinical digital solutions for all types of clinical trials, specialising in medical devices, in vitro diagnostics, pharmaceuticals, and food supplements. Our deep understanding of global regulatory and clinical trial requirements ensures efficient market access and compliance, with patient safety at the forefront.
We are not just another CRO, we are your trusted proactive partner.
We offer turn-key clinical development services
- Clinical trial design and planning
- Conduct feasibility assessments
- Conduct pre-study site visits/screening visits
- Recruitment plan
- Compilation and finalisation of regulatory documents
- Regulatory submission and approval to CA/IRB/IEC
- Manage/track regulatory documents
- Negotiate contracts between sponsors, sites and investigators and assist in the preparation of clinical budgets
- Clinical project management
- Medical writing and preparation of all study documents in accordance with ISO 14155 and ICH GCP
- eTMF/CTMS
- Biostatistical, data management and CRF/e-CRF support
- On-site and remote monitoring visits
- Real-world evidence (RWE) registry management
- Rescue study management
Efficiency and Compliance in Clinical Trials
By leveraging our capabilities, Sponsors can focus on their core competencies while ensuring that their clinical trials are conducted efficiently, in full compliance and to the highest standards of quality.
Achieving Clinical Study Goals Efficiently and Effectively
Our proactive approach ensures exceptional client support by addressing emerging issues in real time, without losing sight of the primary objectives of the study. This approach optimizes the cost-effective use of company resources to achieve goals quickly and efficiently.