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Project Management / Monitoring

Experienced project managers for individual decisions

FGK stands for a tailored-service approach, which considers the individual needs of our partners and the unique characteristics of each study. We cooperate with you closely in all decision-making processes. All project managers in FGK have scientific background and significant experience in clinical research – we are comfortable with making snap decisions and adjusting to your needs and always resolve problems without further ado. Based on your input and needs we design, execute and evaluate the study, and try to keep you posted as to its progress.
 

Local monitoring with global overview

Our monitoring team is made up of motivated and experienced CRAs with relevant academic background and top-notch training. Our CRAs actively participate in certain stages of your study and our project managers are strongly encouraged to perform some monitoring duties themselves; that way, they stay in touch with real-life problems on the ground and keep a global overview of your project. Native speakers are key figures in our international approach to clinical trials enabling us to conduct your trial with ease in virtually any region.

What we do in the Project Management and Monitoring department

  • We develop protocol, (e)CRFs, patient informed consents, study specific plans, forms and procedures
  • We perform feasibility studies, source data verification and complete site monitoring (from its start-up until the close-out)
  • We take care of investigator meetings, drug accountability, central lab set-up, investigator’s payment, quality of data, query resolution, regular study updates for the sponsor, patients’ safety and well-being, sponsors’ questions and concerns
  • We maintain drug / device / material supply, Trial Master File, Investigator Site File and other essential documents, web-based access to study status
  • We deliver results in timely manner and on budget
  • We support sponsor and study sites in finding the most effective approach for patient recruitment.