Clinical Trial Services
genae strives to make your clinical trial a success.
Your advantage of working with genae is captured in our extensive experience in the central coordination and logistics of clinical research projects, including safety & efficacy, different phase studies of new medical devices and therapies (feasibility to post-marketing) and novel drugs (phase II to IV). The transparent structure of genae has been tested rigorously in practice and conforms to all standards of the European Union (EU), International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and the Food and Drug Administration (FDA). In combination with our tailor-made proposals, this structure gives the sponsor a head-start to the clinical trial itself.
Clinical Trial Design
The key to the success of clinical trials is the design of your trial. The design very much depends on the actual purpose of the trial. genae’s experienced staff can support any aspect to define the requirements, the set-up (design) of your project and to plan and execute this accordingly.
genae offers site management services across Europe. Our experienced staff ensures the success of your trial from site initiation to site closure. Managing clinical trials comes down to people management, regardless of the size of the trial. The Clinical Trial Manager sets up a project team for your trial and coordinates the communication between all parties involved; from investigator, committee member, sponsor representative to Clinical Research Associate (CRA). This dedicated Clinical Trial Manager is also responsible for the organization of Steering Committee, Sponsor or Investigator meetings.
We assist you in finding the sites with the right requirements for your specific needs. Our relational network with sites worldwide ensures appropriate and quick selection, based on the requested patient volume, equipment and investigator’s expertise.
Regulatory, Documentation and Reporting
A critical aspect of our responsibility to our clients is to ensure compliance with the changing regulatory guidelines and requirements as well as adapting our services to the emerging trends in submission procedures and technologies. Regulatory support includes Serious Adverse Event (SAE) Reporting, compliant with all regulatory guidelines (FDA and European Regulatory Guidelines).
Adequate monitoring of clinical trials is imperative in assuring the safety and well-being of the involved subjects and the quality of the reported data. The genae Clinical Research Associates are trained in all the disease area and all regulatory aspects of your clinical project. Monitoring is performed across Europe and support or the organization and management of non-EU sites can be provided as well.
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