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.

Project management

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.

Site Selection

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).
We prepare clinical research reports and manuscripts. Our complete study documentation includes the research report with summary tables and graphics, clinical data listings and computer output of statistical analyses. Our corporate SOPs and training programs are designed to ensure that the representation and interpretation of study results are consistent with the Protocol, Statistical Analysis Plan and study data. Our scientific and medical writers are committed to ensuring the clarity and accuracy of all reports and manuscripts.
To maintain the investigator’s commitment, to honor timelines and to keep the sponsor informed, genae offers specific reports to keep all parties up to date on the status of the trial.

Monitoring

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.

genae © 2013