CRO Services for the MedTech industry
As a specialized MedTech CRO 1MED offers end-to-end services covering each step of a clinical investigation, from First In Human (FIH) to observational registries
Expert clinical support for medical devices and IVD compliance
We provide comprehensive CRO services and digital solutions for all types of clinical trials, specialising in medical devices, in vitro diagnostics, pharmaceuticals, and food supplements. As a specialized MedTech CRO we have deep understanding of global regulatory and clinical trial requirements ensuring efficient market access and compliance, with patient safety at the forefront.
A specialty focused medical device CRO offering expertise 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.
MedTech CRO, offering turn-key clinical development services
We are not just another CRO, we are your trusted proactive partner.
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
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
Medical writing and preparation of all study documents in accordance with ISO 14155 and ICH GCP
Efficiency and Compliance in Clinical Trials
By leveraging our capabilities, customers 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
1MED’s 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.
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