Monitoring & Source Data Verification
Our clinical team guarantees up to date knowledge of your trial status at each participating hospital. They have extensive experience and knowledge in the clinical trial field, including monitoring & source document verification.
Trial Document Handling
During a clinical investigation it is important to define the procedure for set-up, maintenance, regular review an archiving of all the study documents in the Trial Master File. This is a service offered by Factory CRO that individually and collectively permits evaluation of the conduct of a trial and the quality of the data produced, and which complies with the standards of ISO14155 and with all applicable regulatory requirements.
To oversee the progress of a clinical investigation, it is important that site visits are regularly conducted. Our clinical team has years of experience in conducting different kinds of visits including pre-study, initiation, monitoring and close-out visits.
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.
As a manufacturer, your clinical investigation can get audited by the FDA, Notified Bodies, or other regulatory agencies. Or, you may wish to conduct an audit at your clinical investigation sites, to ensure quality. Our quality assurance department has the expertise and resources to assist you with regulatory audits, or to conduct audits at sites.