Clinical Study Management
Most companies do not have all of the in-house resources to support a medical device clinical trial. RQMIS can support you by providing those necessary resources that will help you design and implement a clinical study that best suit your business needs. We consider ourselves an extension of your working group, but never lose sight of our role as the service provider. Our goal is to provide you with high quality resources, which in turn will ensure strong project outcomes.
Our experienced project management team works with a team of multilingual clinical professionals, who come from a medical/scientific background. Through a hiring philosophy aimed at attracting experienced and high performing staff, a commitment to comprehensive and consistent training, we strive to provide superior customer service, expertise, innovation, and quality in our clinical trial management services. We approach every project as a collaborative effort, and customize our project team to meet you needs.
RQMIS employees have managed clinical studies/investigations in the US, EU, South America, South Africa and the Middle East. We have worked on all types of medical device clinical trials, including (but not limited to) pilot, pivotal, post market surveillance and Registry studies.
If you have an ongoing clinical study that is being managed to satisfy ISO14155 or FDA Requirements (50, 56, 58, 312 and 812) it is important to understand your state of compliance and ability to pass an FDA BIMO audit. The clinical study dataset will be one of the more valuable assets your company will own and you will want to assure it will pass scrutiny by a third party like FDA. RQMIS consultants have participated in FDA BIMO audits of both sponsors and clinical sites. We have also performed 3rd party audits of clinical study sponsors and their clinical sites to understand the state of compliance with the standard and regulations. Post audit we can help you close the gaps that may be present in your study.
A comprehensive and documented clinical evaluation is a requirement to support your CE marking process. These documents have undergone a heightened level of scrutiny by the notified bodies and Competent Authorities in recent years. RQMIS has authored clinical evaluations for several product families in different therapeutic areas. We can assist you in creating and maintaining your clinical evaluations.
Clinical Study Experience
Our experience includes all classes of medical devices (including Active Implantable Medical Devices) as well as combination products. In addition, RQMIS employees have extensive experience in conducting bioresearch monitoring activities, including FDA sponsor and site audits.
RQMIS’ experienced Medical Device project management team can successfully support your clinical services. The project management team work with a team of multilingual monitors who have paramedical/clinical background. This paramedical/clinical background ensures that monitors are at ease handling medical devices and know how to navigate through the often complex, management systems in hospitals. Monitors are geographically based to ensure as much as possible the proximity with the investigations site. In Europe, RQMIS is convinced that understanding the national language and local culture is essential for efficient monitoring, and even more so in devices where an important product training and procedural component is often involved in the clinical investigation.
Our Clinical Trial services include:
- Study Design
- Project Management
- Biometrics Project Management
- Start up activities (including regulatory submissions)
- Site selection and management
- Clinical monitoring
- Bioresearch monitoring
- Investigator training
- Onsite technical support
- Safety Reporting
- DSMB/CEC Management and Functional sourcing