Trial Management

Clinical Trial Management Services

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.

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

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

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

THE CTNx

Trial Management

Clinical Trial Management Services

The CTNx Trial Management

CTNx handles all of the administrative aspects of trial start-up to allow the site to immediately begin focusing on recruitment.

REGULATORY

BUDGET/CTA

STUDY SUPPLIES

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

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

CTNx handles all of the administrative aspects of trial start-up to allow the site to immediately begin focusing on recruitment.

REGULATORY

BUDGET/CTA

STUDY SUPPLIES

Collaboration with Industry leaders & CROs is critical.

CTNx will find sites with the best trials that fit with their
population and capabilities.

CTNx offers an extra layer of quality support between the sites and the CROs

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