Clinical trials

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Monitoring

Our monitors/clinical research associates guarantee up to date knowledge of your trial status at each participating hospital. Our monitoring activities consist of:

  • Pre-study & initiation visits
  • Monitoring visits
  • Source Document Verification
  • Close out visits
  • Trial document handling
  • Reporting of safety information
  • Administrative tasks

SAE/AE reporting

Our MDs are experts in the safety evaluation and handling of Serious Adverse Events that are reported during the trial follow up period.

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Clinical monitoring

One of the services that distinguish us from conventional CROs is our clinical monitoring service. We are proud to have experienced technical experts in different clinical fields who can provide monitoring of clinical procedures so that you can verify that your device is used as you intended.

International Clinical Trial Rescue

We are proud to offer our early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by FDA or European regulators. We developed a rescue assessment program that can be implemented in as little as three weeks. It includes an audit of the collected data, discussions with senior management about study objectives, review of protocols to identify trouble areas related to enrollment, regulatory compliance, and expert advice on a recovery plan. Finally we can assist with the implementation of the rescue plan.

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