Clinical investigation

FULL-SERVICE CLINICAL INVESTIGATION CONSULTANCY

We provide full-service clinical investigation consultancy services to help you generate clinical data, pre-market as well as post-market introduction of your medical device or device system.

Our team will help you to effectively integrate your clinical investigations into your go-to-market model. This includes investigations such as; first in human clinical investigations, feasibility or pilot clinical investigations, RCTs, as well as registry and PMCF.

 

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Ensuring patient safety through medical devices

Our aim is to provide services that enable your company to allow patients to benefit from your device as quickly and safely as possible. When working with us, you will be part of a team that specializes exclusively in clinical investigations for medical devices.

Furthermore, our Quality Management System (QMS), based on ISO 14155, is specifically tailored to the requirements for clinical investigations of medical devices. When designing clinical investigations, we always consider the reimbursement landscape in order to make the device available to as many users as possible.

We guide our clients through all the steps needed for clinical studies and make the journey from study idea to fully executed study swift, transparent and agile.

Our services includes

  • Clinical Investigation Documentation (ISO 14155, MDD 93/42/EEC, MDR 2017/745, 21 CFR parts 50, 56, and 812)

  • Project Management

  • Submission to Ethics Committees and Regulatory Authorities

  • Site selection, Site Initiation and Site Closeout

  • Data Management

  • Biostatistics

  • Safety monitoring

  • Risk assessment

  • Publications

  • Monitoring

  • Audits

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Whether you have questions regarding regulations, clinical strategies, educations or need help with an audit, you are always more than welcome to contact us.

Our ecosystem for full-service medical device compliance

We are your full-service medical device partners. Together we offer unique expertise regarding Quality Assurance, Regulatory Affairs, Clinical Affairs, Biological Evaluations & Toxicology.