CTNx TRIAL MANAGEMENT
START-UP
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
DATA MANAGEMENT
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
- Cannot start visit without entering in completed Informed Consent
- Locked fields only the investigator can complete
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
TRIAL OVERSIGHT
CTNx provides an extra layer of oversight between the CROs and Sites.
- CTNx is onsite for the SIV and first visits to ensure the site staff is properly trained on the protocol
- Sites have access to the CTNx regulatory/compliance teams and CTNx Sr. Investigators 24/7 for questions/guidance
- All Screened Subjects’ must be sent to the CTNx Compliance Officer for review and approval prior to randomization
- Sites will be required to record 1 randomly selected Informed Consent for CTNx to review
- CTNx will monitor IP Temperatures and be notified instantly of any excursions
ENGAGING THE INDUSTRY
Collaboration with Industry leaders and CROs is critical.
- The structure and 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
SITE BENEFITS
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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