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.
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Christoph Ganss, Rheacell
Founder & CEO
“We have been collaborating with FGK for many years, and their professionalism, flexibility, and deep expertise in clinical trials have consistently exceeded our expectations. Their team's ability to adapt quickly while maintaining the highest quality standards has been instrumental in the success of our Phase I/IIa and Phase IIb studies across multiple indications. The involvement of the upper management in all kinds of discussions is highly appreciated, again during our ongoing Phase III trial. We highly value this partnership and look forward to continuing our successful collaboration.”
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Kate Hanrott, EpiEndo Pharmaceuticals
Director Clinical Operation and Sciences
“FGK conducted two high quality studies for us, so it was an easy decision to place our next study with them. All members of the FGK team are a pleasure to work with. They are quality focused and always happy to go the extra mile. The project management team are highly experienced and do a fantastic job to lead the study team and ensure high quality delivery. We have been consistently impressed by the data management team, and we have received really positive feedback from our clinical investigator sites about how helpful and thorough the monitors are. We are really enjoying our partnership with FGK.”
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Gautier Sobczak, My-Data-TRUST
Co-Founder & Chief Business Officer
“FGK is a long-standing and trusted Partner who identified early on the critical importance of data privacy in clinical research. We've been working together for many years, combining their strong clinical expertise with MDT's data privacy know-how to support Sponsors in enhancing efficiency, ensuring compliance, and building trust in the data collected. The trust developed over time enables fast, high-quality results on both sides, and we look forward to continuing this successful partnership journey!”
