The Clinical Program Process
The Nu-Life Solutions medical and clinical leadership has devised a set of standard operating procedures for each Nu-V3 initiative and clinical program. The objective is to ensure that each program operates by the same set of standards, protocols and clinical process. While there may be unavoidable differences due to regulatory and resource capabilities in a region, it is important to hold very close tolerances on each element of the clinical process. This allows for a higher level of validation and acceptance of results and data.
The Nu-V3 clinical initiative opportunities have been identified. Each initiative will proceed under the same specific set of standards, protocols and procedures to ensure the validity and quality of the data.
The Nu-V3 clinical program has been IRB approved since 2018 with the specific results and data collection to be:
The mitigation or elimination of the symptoms of pain, anxiety, depression and sleeplessness
Changes (hopefully increases) in activity
Overall improvement in quality of life
Mitigation or elimination of pain meds
The past 12 months we have added and upgraded the treatment program to include direct delivery of Nu-V3 and the ability to manage the patient remotely, should this be desired. The IRB approval will be updated to reflect these changes. Other than these changes, the protocol and outcome objectives remain the same and consistent through each and every clinical program. One area we may beef up is the mitigation or elimination of pain meds. Because this is such a huge issue and permeates every single patient population, we may want to give it some special attention and dynamic ways to report results.
In addition, there are a number of elements to these programs that have been completed and do not require further effort at this time. While these items will be up for discussion in the next phase of clinical programs, we will move forward with what has been finalized. These items are:
IRB approved protocol for multi-site and multi-discipline is a perfect fit for what we are going to accomplish in this round of programs.
Study design – single arm, comparative study. Remember this effort is to take patients with history of chronic symptoms and demonstrate the short and long term relief from Nu-V3.
The Non-Significant Risk (NSR) designation by IRB. An important designation for our labelling and allows for expedited review by both IRB and FDA.
Patient populations. Our existing list of initiatives and populations.
There are also a number of elements which are in final stages of completion so we may incorporate in this round of clinical programs. They are:
Updated Instructions for Use
Updated Use and Care Instructions
Pull tab activation of the device. Test, test, test.
Test runs of the HRV hardware and software
Shipping and returning of devices
A note about devices: Each Nu-V3 device supplied for the initiatives and clinical programs will be labelled 'For Investigational Use Only'. This also applies to the PAD assemblies and packaging. Each device comes with a serial number which identifies the production lot, program region, the specific initiative and the program stage, such as Pilot or Stage 1. As we often get requests for devices to be sent for initial testing etc, it is important to understand the standards we must comply with.
While the main objective is to demonstrate the safety and effectiveness of Nu-V3, the secondary objectives are critical for providing a truly effective, long term benefit. Because each pilot and clinical program is nearly identical to the comprehensive programs we will be delivering upon market entry, these initiatives provide the opportunity to test and refine all elements from device delivery to patient education and virtual management through telemedicine.
The Steps of the Initiatives:
I. The Introduction
Share materials. Device, program, clinical protocol and data collection tools.
Intro meeting with Nu-Life Clinical Initiative Team. Review items in this document.
II. The Review – touch, feel, wear the device for familiarization
The device application process
The program execution
III. The Pilot
5 - 10 patients directly connected to clinical leadership.
Focused patient population
This is where it gets real. By this time we should have figured out any needed tweaks to the device, program and method of results and data collection.
IV. Stage 1
Expanded patient participation.
This is where we invite others to view the program and report. New media, prospective providers and corporate clients and peer reviewed documents. Creating real demand for Nu-V3 begins here. PR begins here.
V. Stage 2
Expanded patient populations. While Stage 1 is still focused on a narrow set of inclusion and exclusion criteria, in Stage 2 we can expend to include a wider population, such as those suffering from PTSD that are outside the vet or military space.
VI. Stage 3
Add data points specific to patient populations, ie, additional questions regarding PTSD or RA. This is where validated questionnaires for specific issues can be added for provider and consumer buy-in.
It’s important not to get to this point until final FDA submission is complete, as this could trigger FDA to require a 510k for each patient population. Something we have successfully navigated to date.