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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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