The CTNx Trial Management
The CTNx’s trial management services provide the infrastructure, technology, and expertise needed to seamlessly integrate research into your current workflow. We make clinical research easy for you.
Start Up
Data Management
Trial Oversight
Engaging The Industry
Site Benefits
CTNx handles all of the administrative aspects of trial start-up to allow the site to immediately begin focusing on recruitment.
REGULATORY
- Turnaround for Start-Up Documents is 48-72 hours
- Regulatory Documents are available 24/7 for CRO to review via 21 CFR Part 11 Compliant cloud-based platform
- CTNx submits initial submission to IRB in parallel with budget/CTA negotiation
BUDGET/CTA
- CTNx negotiates one for all sites in the network to eliminate delays in Start-Up
- Budget/CTA turnaround is 48-72 hours
STUDY SUPPLIES
- CTNx provides each site with the necessary supplies needed to conduct the trial before SIV
- Ex. -70 freezer, TempAlert, Infusion Pump, etc
CTNx utilizes a 21 CFR Part 11 Compliant Cloud-Based Electronic Source System which provides CRO 24/7 remote access to the source.
CTNx provides each site with an iPad to complete the visits loaded with the pre-made source
User friendly program with protections set to avoid human error
Unable to close visit without completing all required study procedures
Once data is entered into the system, it is monitored in real-time by CTN’s compliance officer for completeness and accuracy. Data is entered by CTN’s data entry team
- Ensures 3 sets of eyes have seen the data before entered into the EDC
- Data entry is completed within 48 hours of visit occurrence
CTNx handles all of the administrative aspects of trial start-up to allow the site to immediately begin focusing on recruitment.
REGULATORY
- Turnaround for Start-Up Documents is 48-72 hours
- Regulatory Documents are available 24/7 for CRO to review via 21 CFR Part 11 Compliant cloud-based platform
- CTNx submits initial submission to IRB in parallel with budget/CTA negotiation
BUDGET/CTA
- CTNx negotiates one for all sites in the network to eliminate delays in Start-Up
- Budget/CTA turnaround is 48-72 hours
STUDY SUPPLIES
- CTNx provides each site with the necessary supplies needed to conduct the trial before SIV
- Ex. -70 freezer, TempAlert, Infusion Pump, etc
Collaboration with Industry leaders & CROs is critical.
- The structure & goal of CTNx will be shared to gain input from the leading pharma companies in CTNx.
- Collaboration with CROs is equally important to streamline the process of bringing the cohort of sites into the right trials, and to provide the extra oversight that CTNx promises.
- An Advisory Board will be developed, including members of Pharma, researchers, CRO’s and the healthcare field at large
CTNx will find sites with the best trials that fit with their
population and capabilities.
- Assist all sites with Start-Up, IRB Submissions/ Communications, Trial Financials and Data Management
- Provide resources at the Coordinator and PI level; provide additional training for coordinators, both through internal and external resources
- Real-time monitoring of trial data through a remote Q/A infrastructure
- CTNx’s senior PIs will provide direct support/training to the new PIs
CTNx offers an extra layer of quality support between the sites and the CROs
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Contact us to learn more about what we can do together to advance clinical research!