Study and Site Management
The strength of the Therapeutics Development Network Coordinating Center (TDNCC) lies in our unparalleled experience in setting up and managing CF studies and our intimate knowledge of the CF research community.
From study design to study materials development, from site selection to site startup, we can provide the guidance, feedback and tools that will enable your study to be successful.
Clinical Project Oversight
Experienced study managers oversee each clinical study and serve as the single point of contact for sponsors and lead investigators. Services include:
Leveraging TDNCC resources and insights can help sponsors streamline the process of site selection and help ensure the most appropriate sites are selected for each study. Here are some of the ways we can help:
The TDNCC has developed a set of standard systems, procedures and document templates that are custom-tailored for CF studies and frequently used by staff at TDN study sites. Utilizing these familiar tools increases efficiency while maintaining quality and consistency. Services include:
Site Startup and Training
TDNCC study managers and site monitors have established strong and consistent working relationships with CF clinical research teams across the country. This mutual understanding enables all parties to interact more effectively right from the beginning. Site startup and training services include:
Site Management and Monitoring
In addition to our working relationships with CF study site personnel, we are knowledgeable about the unique aspects of CF studies, including specialized procedures and specimens. This combined expertise makes us extremely effective at managing and monitoring CF study sites. Services include:
Specialized Study Implementation Support
If you already have a clinical operations team in place to implement your study, the TDNCC can still help by providing CF expertise and insights into the CF community. Below are some examples of how we have supported the implementation of such studies:
Additional services offered through the TDN Coordinating Center include: