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Biometrix Inc

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San Francisco, California, US

About Biometrix Inc

Biometrix, is a branded global CRO and has been conducting clinical trials to support claims in many industries for over 25 years. We are  partnered with over 15 doctors and have access to a 20,000 patient database for all of our studies.

 

We have supported major multinational biotech, pharmaceutical, natural products, dermatology, cosmetics, wellness, nutrition, medical devices, and product manufacturers in clinical trials, claims support, regulatory services and many other activities around the world.

 

Not only do we conduct clinical trials, we assist you in all phases of clinical trials to ensure successful product development. Partner with Biometrix and be the first to market with proof of concept and matching regulatory standard with user experience.

Our Services (6)


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Clinical Research

Price on request

Clinical Research - Phase (I-IV) Clinical Trials

Biometrix understands your need to move your product through the development pipeline expediently. Our Phase I – IV clinical research programs are designed to help streamline this process while providing our clients with value added service at a fair and competitive rate.


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Clinical Trials, Consulting, and Management

Price on request

Pre Study

  • Protocol design and development
  • Site/Investigator selection
  • Central file setup
  • Site contract and budget
  • Regulatory document collection and IRB submission
  • Investigator meeting preparation and execution
  • ICF, CRF (written or electronic), patient information leaflet 

Study Management

  • Monitoring and site management
  • Clinical monitoring plan
  • Medical monitoring/SAE reporting
  • Routine communication with the sponsor
  • Generation of status reports
  • Liaison with external vendors
  • Investigator/vendor payments
     
    Data Management/Biometrics
  • Data entry, data verification, statistical analysis plan, data management plan, validated programming
     
    Medical Writing
  • ICH compliant reports, manuscripts, summaries, Investigator Brochures, document archiving
     
    Translation Services
  • Certified translators with various skill sets (technical/medical writing, editing)


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Medical Devices & Diagnostics

Price on request

Biometrix also does testing on medical devices and we provide all of these services: 

  • Regulatory Correspondence
  • Import/Export Requirements
  • Technical Files
  • Compliant handling and reporting
  • Quality Systems training for production and management
  • Audit services
  • Liaison with FDA
  • Inspection preparations
  • Device Classification
  • IDE/510K/PMA and International Submissions
  • Labeling/Advertising Review and Strategy


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Cosmetic and Personal Care Product Testing

Price on request

Safety testing of cosmetics and personal care products (skin care, feminine, care, nail care, oral care, hair, ethnic, include repeat irritation and sensitization in large groups of healthy subjects of diverse backgrounds, as well as photoallergenecity and phototoxicity studies.

 

Efficacy testing of skin products that address skin integrity (firmness, sagginess, viscoelasticity), wrinkles, acne, sun protection factor, sebum production have been conducted at Biometrix. All studies are done under the direct supervision of a board-certified dermatologist.


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Project Management

Price on request

- Clinical Research & Scientific Product Development
- International Regulatory Compliance & Management
- CRO (Contract Research Organization) Management
- Medical Affairs Services
- Product, process and clinical operations development from concept to commercialization of pharma, medical devices, diabetes devices, wearables) dermatology, beauty, and personal care, dietary supplements,, functional foods, and cannabinoid, clinical testing, regulatory compliance and project management

- Design, and substantiate long lasting, and ownable claims,
- Design and manage development of products for multi ethnic patients and consumers (pharma. devices, skin care, dermatology, and dietary supplements)
- Develop testing methodologies and claims substantiation methods for health and consumer products for multi ethnic population
- Recruit Global panels of multiethnic patients and subjects to participate in clinical trials of pharm, consumer products globally


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Product Development Consulting

Price on request

Our consultants and staff are capable of providing scientific/medical/product reviews of in-licensing candidates for the pharmaceutical/cosmetic/personal care industries. A full comprehensive report, including market research, can be provided to aid in due diligence.

 

Depending on the product and where it is in its lifecycle, we can assist the sponsor in the evaluation of the data, prioritization of the portfolio, identify new opportunities, minimize time to market, and optimize resource allocation

 

Our network of consultants can locate potential partners for your product in the US and Asia.


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Hugo Neves

Managing Director

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