High Alert Institute

Experts4Good

 

 

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Your Project + Our Expertise = Unparalleled Impact

Safe and effective products are the true  endpoints of research and development. The High Alert Institute provides donation-based project consultation for select corporate partners and sponsors. We have assisted our clients in achieving tremendous success in securing global regulatory approvals for de novo and legacy technologies. We support you on the continuum of your regulatory pathway, from submission to maintenance of post-market compliance.

We understand that research and development are a global market race with ever-changing regulations and goals. The integrity and accuracy of scientific content for your submissions, however, should be a constant. We provide that solid foundation and allow your team to cross the finish line successfully.

HOW EXPERTS4GOOD WORKS

Individuals, Groups, Businesses and Research Facilities can become a Partner4Good by completing the Partner4Good form. Click on the High Alert Institute logo to apply today.
Individuals, Groups, Businesses and Research Facilities can become a Partner4Good by completing the Partner4Good form. Click on the High Alert Institute logo to apply today.

BECOME A PARTNER4GOOD

Project data and intellectual property are held in strict confidence. All information shared by our Partners4Good is stored solely on our in-house, secured servers. When you apply for Research & Development Support, we will send you a Memorandum of Understanding for Synergistic Effort (MOUSE) and a Non-Disclosure Agreement. Once these documents are executed, we schedule a meeting to discuss your project. Click on image to download a sample MOUSE.
Project data and intellectual property are held in strict confidence. All information shared by our Partners4Good is stored solely on our in-house, secured servers. When you apply for Research & Development Support, we will send you a Memorandum of Understanding for Synergistic Effort (MOUSE) and a Non-Disclosure Agreement. Once these documents are executed, we schedule a meeting to discuss your project. Click on image to download a sample MOUSE.

CONFIDENTIALITY

Businesses and individuals can become a member of 1% for the Planet by committing 1% of annual income directly to environmental causes. Businesses and individuals support Projects4Good with the in-kind donation of volunteer time and/or cash support to the High Alert Institute. Because the High Alert Institute is an official Environmental Partner of 1% for the Planet, the time and treasure donated to your sponsored Project4Good may count towards your 1% for the Planet commitment. For more information on Membership in 1% for the Planet, click on the 1% for the Planet logo.
Businesses and individuals can become a member of 1% for the Planet by committing 1% of annual income directly to environmental causes. Businesses and individuals support Projects4Good with the in-kind donation of volunteer time and/or cash support to the High Alert Institute. Because the High Alert Institute is an official Environmental Partner of 1% for the Planet, the time and treasure donated to your sponsored Project4Good may count towards your 1% for the Planet commitment. For more information on Membership in 1% for the Planet, click on the 1% for the Planet logo.

MAXIMIZE YOUR IMPACT

You choose the pathway and set the milestones. We share the workload and help you finish strong. Your goals are at the center of everything we do. Whether we serve as your virtual staff or perform discrete project work, we ensure alignment with your primary objectives.
You choose the pathway and set the milestones. We share the workload and help you finish strong. Your goals are at the center of everything we do. Whether we serve as your virtual staff or perform discrete project work, we ensure alignment with your primary objectives.

YOUR VISION – YOUR ACHIEVEMENT

Our team possesses substantial industry experience, consulting for start-ups to mid-sized companies to some of the largest global medical device corporations. Partnering with clients to complement their internal resources, we work closely with client design and development teams to support their efforts. We bring more than 50 years of combined expertise to every project.
Our team possesses substantial industry experience, consulting for start-ups to mid-sized companies to some of the largest global medical device corporations. Partnering with clients to complement their internal resources, we work closely with client design and development teams to support their efforts. We bring more than 50 years of combined expertise to every project.

OUR EXPERTISE

Robust, systematic reviews of the scientific literature are integral to successful regulatory submissions. We systematically mine and collate data from the scientific literature data, providing you with a statistician-ready dataset for analysis. This speeds your progress to study endpoint, performance goal, and OPC (objective performance criteria) development.
Robust, systematic reviews of the scientific literature are integral to successful regulatory submissions. We systematically mine and collate data from the scientific literature data, providing you with a statistician-ready dataset for analysis. This speeds your progress to study endpoint, performance goal, and OPC (objective performance criteria) development.

SYSTEMATIC SCIENTIFIC LITERATURE REVIEWS

Safe and effective medical devices are the true endpoints of regulatory requirements. We design, execute, and adjudicate customized searches of international databases to provide you with high-quality safety data. This allows for Real World experience to inform the development of your device. We collaborate with your team to troubleshoot and achieve cost-effective and time-efficient solutions while ensuring trackable, reproducible, and adjudicated data is derived from the world’s safety and adverse event databases.
Safe and effective medical devices are the true endpoints of regulatory requirements. We design, execute, and adjudicate customized searches of international databases to provide you with high-quality safety data. This allows for Real World experience to inform the development of your device. We collaborate with your team to troubleshoot and achieve cost-effective and time-efficient solutions while ensuring trackable, reproducible, and adjudicated data is derived from the world’s safety and adverse event databases.

FAILURE MODE & ADVERSE EVENT DATABASE ADJUDICATION

Our data mining and analyses of the scientific literature have an excellent track record of approval for meeting all of the following objectives for both industry and academic clients: safety and performance requirements, clinical study endpoints, and development of objective performance criteria (OPC).
Our data mining and analyses of the scientific literature have an excellent track record of approval for meeting all of the following objectives for both industry and academic clients: safety and performance requirements, clinical study endpoints, and development of objective performance criteria (OPC).

DATA MINING & ANALYSIS

Our preparation of statistical analysis includes the following: collation of literature-derived data, collation of adjudicated data derived from failure mode databases, set-up of standard format data analysis tables, formatting of statistical analysis for confirmation by your statistician, preparation of tables and figures to support Fleiss-derived endpoints, performance goals, and OPCs for your submission or publication.
Our preparation of statistical analysis includes the following: collation of literature-derived data, collation of adjudicated data derived from failure mode databases, set-up of standard format data analysis tables, formatting of statistical analysis for confirmation by your statistician, preparation of tables and figures to support Fleiss-derived endpoints, performance goals, and OPCs for your submission or publication.

PREPARATION OF STATISTICAL ANALYSIS

 EXPERT REVIEW & ASSISTANCE FAQ

Q: Can we use our company's Nondisclosure Agreement rather than the one the Institute provides?

A: The High Alert Institute is willing to review your company’s Nondisclosure Agreement for compliance with the restrictions on agreements for 501c3 public charities. We are very willing to use your NDA if approved by our legal team.

Q: Can we use our company's consultant agreement rather than the the Institute's MOUSE?

A: The High Alert Institute is willing to review your company’s Consultant Agreement for compliance with the restrictions on agreements for 501c3 public charities. We are very willing to use your agreement if approved by our legal team.

Q: Can we use our company's Partnership Agreement rather than the the Institute's MOUSE?

A: As a 501c3 Not-for-Profit public charity, the High Alert Institute barred from entering into financial partnership or revenue sharing agreement with for profit entities. The Institute is willing to review your company’s proposed agreement for compliance with these restrictions. We are very willing to use your agreement if approved by our legal team.

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High Alert Institute

4800 Ben Hill Trail
Lake Wales, FL 33898
Office: 863.696.8090
FAX: 407.434.0804

Info@HighAlertInstitute.org

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Griffin Works offers Pawsitive Interactions with Service Dogs During Response Operations©, an audience-customized training that breaks down barriers by offering hands-on handling training and demonstrations with working service dogs for fire departments, EMS agencies, and public safety organizations.

Part of the National Domestic Preparedness Consortium and home to the National Emergency Response and Recovery Training Center, TEEX has been leading homeland security training since 1998. The major TEEX programs include fire and rescue, infrastructure and safety, law enforcement, economic and workforce development, and homeland security. As a member of The Texas A&M University System, TEEX is unique in its ability to access a broad range of emerging research and technical expertise. Beginning with course design and development all the way through hands-on instruction and national certification testing, TEEX delivers comprehensive training through both classroom and hands-on instruction and as online courses.

The National Child Traumatic Stress Network (NCTSN) was created by Congress in 2000 as part of the Children’s Health Act to raise the standard of care and increase access to services for children and families who experience or witness traumatic events. This unique network of child-serving professionals, caregivers and young adults, researchers, and national partners is committed to changing the course of children’s lives by improving their care and moving scientific gains quickly into practice across the U.S. The NCTSN is administered by the Substance Abuse and Mental Health Services Administration (SAMHSA) and coordinated by the UCLA-Duke University National Center for Child Traumatic Stress (NCCTS). 

The Emergency Management Institute (EMI) is part of the Department of Homeland Security’s Federal Emergency Management Agency (FEMA). The EMI provides national leadership in developing and delivering training to ensure that individuals and groups having key emergency management responsibilities possess the requisite skills to effectively perform their jobs.

The High Alert Institute maintains a list of reviewed courses provided by governments, universities and professional organizations. This list is geared towards the non-emergency management person who participates in disaster planning, preparedness, response, recovery or mitigation as part of their job responsibilities.

The High Alert Institute has partnered with Shutterstock to distribute stock images from the nature images donated by our supporters. For eligible stock images, Shutterstock will donate a portion of the royalty to the High Alert Institute. There is no cost to charitable organizations or to Shutterstock customers.

For eligible purchases through AmazonSmile, the AmazonSmile Foundation will donate 0.5% of the purchase price to the High Alert Institute. There is no cost to charitable organizations or to AmazonSmile customers. All you need to do is push the SMILE NOW button and select to support THE HIGH ALERT INSTITUTE on AmazonSmile.

Koi need forever homes, too! For pond enthusiasts, freshwater exotic and ornamental fish may not be available through pet stores or rescues in their area. The High Alert Institute Aquatic Pet Shelter Rehoming Program will be happy to assist you in stocking your new pond or adding a new finned friend to your school. Coming soon – when you adopt a Koi from the High Alert Institute Aquatic Pet Shelter Rehoming Program, we can arrange for delivery to your door anywhere in the continental United States.

Have you always wanted a Koi pond but don’t have the space one? Sponsor a Koi in our community shelter pond and we send you photos of your sponsored animal. Coming soon are live Koi Cameras above and below the water to enjoy your sponsored Koi anytime.

Dumping of freshwater non-native species and exotic aquatic pets into wild habitats is a man-made disaster that is truly preventable. The Institute’s Aquatic Pet Welfare Partnership works to raise awareness and reduce the impact on healthy ecosystems through education, as well as rescue and rehoming. Joined by champions of animal welfare and environmental stewardship, this  association of aquatic pet rescue operations and aquatic pet shelters across the United States aims to save our finned friends and preserve our waterways together.

Want to share our cause with family, friends, and colleagues? Looking for a non-traditional way to celebrate a birthday or honor someone special? Support the Institute by starting your own Peer-to-Peer fundraising challenge! Let your contacts know why our mission is important to you and what they can do to support your cause. START YOUR OWN FUNDRAISER for the High Alert Institute.

From the staffing pool to the shelter ponds, from the boardroom to the classroom, and from reading the science to writing the analyses, High Alert Institute programs and services benefit from the experience, expertise, and generosity of our volunteers. Put your talents to use for good and to good use – VOLUNTEER TODAY.

Make your donation twice as nice by rehoming aquatic pets and providing a rehabilitation companion pet to a deserving person, family, or facility. Sponsor part or all of a Joy of Koi Program pond installation – complete with rehomed koi – and give the gifts of love and recovery.

Professional photographers, amateurs, and legal copywrite holders are all welcome to participate in the High Alert Institute Nature Photo Donation Program. Sales of the images benefit the Institute and donors are eligible for tax deductions equivalent to the fair market value of their photos. Landscapes, seascapes, animals, flowers – all may be accepted – whether new or vintage  images. People may be included in the photo but only if unidentifiable (i.e., blurred figures at a distance).

Did you know that unused patents and copyrights can be donated to charity? Intellectual Property (IP) just sitting on a shelf will lose value as it becomes obsolete. The High Alert Institute IP Donation Program seeks to rescue stranded, technology-related IP with the potential for development into marketable products. Once accepted by the program, the owner/inventor is eligible for a tax deduction equivalent to the fair market value of the IP. The Institute receives the patent licensing fees or revenue from the sale of the IP to businesses, helping us to fund our mission. In turn, businesses are able to advance their markets and create jobs for less money than starting a project from scratch.

Disasters are defined as situations in which needs exceed or overwhelm available resources. Some disasters affect an entire community, while other disasters impact individuals and families. Crises of physical or psychological health can be very personal disasters.
The therapeutic value of pets during illness, trauma, and recovery is well established. And Koi fish may be well suited for people who are not able to provide verbal pet commands or physically care for pets like dogs and cats. Koi ponds are also a source of beauty and peace, providing an ideal setting for quiet reflection or meditation.
We are working to partner with pond installers and aquatic pet rescues/shelters to offer free or reduced-cost ponds with rehomed Koi fish to people seeking this type of pet therapy.

Disasters disrupt life and impact our sense of personal, family, and community safety. Survivors and responders alike often are not aware of the emotional, psychological or spiritual challenges that they may face from disaster onset through recovery. With two decades of experience training responders and communities to prepare for the behavioral health aspects of disasters, we will continue to provide education and a curated list of resources to groups or individuals.

Non-medical factors that impact overall health are termed Social Determinants of Health or SDoH. Noise pollution, poor air quality, and poor water quality are three environmental factors known to have a strong link to overall health. And the same environmental factors that impact humans impact their pets and other animals in their care. We continue to assist in advocacy, education, and technology development to mitigate the impact of SDoH on humans and animals alike.

Our efforts in shelter and rescue are the main focus of our environmental stewardship, reducing the environmental impact of non-native aquatic animals being dumped into public waterways. The High Alert Institute also assists innovators with the design, development, and evaluation of green and renewable energy technologies. Reducing the carbon footprint associated with disaster preparedness, response, and recovery furthers our continued mission to mitigate risk and improve resilience.

We partner with public and private organizations, sharing resources and fostering partnerships to improve disaster preparedness, response, and recovery, and mitigation.

The High Alert Institute team has over a century of combined research experience in medical, nursing, behavioral health, and disaster sciences. Our team provides support to researchers and technology developers through comprehensive literature searches and reviews, as well as failure mode database searches and adjudicated reviews.

When disaster strikes, most aquatic pet owners have limited options to secure the safety of their pets. Sheltering in place may not be possible if there is no power to provide aeration and “pet-friendly” shelters do not include ponds or aquariums. Our goal is to provide an option for aquatic pet owners in need of rescue and shelter for their finned friends.

Our goal is to share our two decades of disaster readiness experience with animal welfare organizations, shelters, caretakers, and pet owners, as they implement contingency  plans for natural and manmade disasters.