Innovative & Creative Clinical Research
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. From the initial product concept through each subsequent development phase, Biometrix helps clients achieve regulatory approval through the creation of innovative protocols, claim substantiation, product testing, and consulting services.
Clinical Research Expertise
Biometrix clinical research staff has over 15 years experience in testing drugs, cosmetics, medical devices and consumer products. Our methodology is constantly evolving due to our participation and affiliations with various medical groups and industry organizations. We are passionate about our work and pride ourselves on working continuously to ensure our clients success.
Customer support is our competitive advantage. We at Biometrix enjoy working closely with our customers and are dedicated to providing each of our clients with personal service. Our staff will accompany and guide you through each step of your project ensuring that objectives and time lines to market are met. Because your trust requires more than quality, you can depend on Biometrix, your partner for reliable service from product concept to the consumer market. For more information or to speak with a representative please feel free to contact us.
Clinical Research Services
- BIOANALYTICAL SUPPORT
- CRF DESIGN, REVIEW & PRINTING
- CLINICAL RESEARCH & TESTING FACILITY
- CLINICAL SUPPORT & RESOURCES
- DATA QUALITY ASSURANCE
- FORMULATION & MANUFACTURING SUPPORT
- INTERNATIONAL PRODUCT MARKETING
– REGULATORY SERVICES
- IRB REVIEW, EXPEDITED & FULL
- INVESTIGATOR CONTRACTS & PAYMENT ADMINISTRATION
- LARGE PANELIST POPULATION
- LARGE SUPPORT NETWORK
- EXPERIENCED CLINICIANS
- CLINICAL RESEARCH INVESTIGATORS
- PERSONAL COMMUNICATION & CONSULTATION PRODUCT DEVELOPMENT
– STUDY PROGRESS, RESULTS & INTERPRETATIONS
- PRODUCT DEVELOPMENT
- PROTOCOL DESIGN & REVIEW
- REGULATORY & COMPLIANCE
– DOCUMENTATION PERPARATION & COLLECTION
- QUALITY ASSURANCE/QUALITY CONTROL
– ALL PHASES OF CLINICAL STUDY
- REPORT WRITING
– ETHNICALLY DIVERSE
DISCOVERY! Giving Your Decision More Precision
Our early phase development services are dedicated to improving your decision making process. Working with Biometrix Clinical Research Services will give you the advantage you need in accomplishing first phase clinical product development. Discovery Services are currently offered in the following segments:
- HEALTH CARE
– RX AND OTC PHARMACEUTICAL
+GI, CHOLESTRTOL, FLU, DIABETES, WOUND CARE, ANALGESIA, ANTI-VIRAL, RHEUMATOID ARTHRITIS, ASTHMA
- DIAGNOSTIC MEDICAL DEVICE
- DRUG DELIVERY SYSTEMS
- PRODUCT FORMULATIONS
– THERAPEUTICS, DERMAL CARE, PERSONAL CARE, COSMETICS, HAIR & NAIL
- EYE CARE
- ORAL CARE
Product Concept to Market and Beyond!
At Biometrix our innovative and proactive Early Discovery Program (Early Product Candidate Selection in Man – “fast-into-man”) eases your Phase I decision making process allowing for rapid and accurate results in early product development.
Biometrix experience is unrivalled in the early clinical assessment phase of testing novel products in humans. Our proof-of-principle studies are designed to determine safety and tolerance and to gain early evidence of efficacy. Since these studies are undertaken in man, they offer greater predictability versus animal and ex vivo models. By moving into “first-in-man” studies as soon as possible clients save time, cost, and materials while allowing drug candidates to be evaluated effectively and efficiently.
Our expertise in the use of clinical technologies and human absorption studies has been recognized world wide making us a leader in assessing the feasibility of successful product development. Biometrix services project manager believes in utilizing a team approach and will work closely with you to ensure that the study is designed and performed to your specifications.
Biometrix has affiliates worldwide and can act as an intermediary and/or provide consulting services to clients looking to market their products internationally. We will develop a plan for executing your Phase II-IV Clinical Trials, in the United States and abroad, which are agreed upon by all parties. This allows us to deliver clean and accurate data on time and within your budget. Finally, since we understand the importance of your data with regard to your registration and marketing dossier, we will make certain that all studies, data capture and documentation systems meet FDA Standards and worldwide regulatory (Monograph, NDA & PDA) requirements.
A Contribution to Living Healthy, Beautifully and Safely
Biometrix is dedicated to serving the people and making a contribution to society through the research and development of diagnostic medical devices as well as the determination of safety profiles for drugs, cosmetics, and medical devices during Phase I studies. Through alliances with government agencies (Department of Defense), research organizations and corporations, such as Syntron Bioresearch, we have investigated innovative solutions for biological and chemical warfare detection and monitoring. We are also in the process of developing innovative solutions for, among other things, disease detection and monitoring.
- TOXICOLOGICAL SERVICES
- SPECIALTY STUDY
- PROTOCOL DESIGN
- RESEARCH & DEVELOPMENT
– MEDICAL DEVICES
– PARTNERSHIPS & ALLIANCES
- CUSTOMIZED & SPECIALIZED SERVICES
– DRUG DELIVERY
– TRANSDERMAL, BIOANALYTICAL SERVICES
Contract Product Development Services
For years, clients have praised our ability to create innovative solutions in the most cost-effective way. Our recent growth has expanded our service capabilities allowing us to offer Rx and OTC pharmaceutical, medical device and biotechnology companies with an array of high quality contract R&D services and solutions.
Currently, Biometrix is recognized throughout the industry for our specialized work in skin disease, wound healing and repair. We deploy state of the art technology toward the development of skin-repairing and wound-healing products. Our scientists excel in knowledge of medical science and medicine used exclusively in these product segments. These skills are applied to the effective delivery of medications and the re-engineering of existing formulations and devices to treat skin.
The successful development of therapeutic products begins with evaluating product efficacy properly, and understanding the biochemistry, PK, Chemistry, and clinical basis of skin diseases. The following provides a snapshot of approaches used by Biometrix when evaluating products.
- ENHANCED DELIVERY SYSTEM
- EFFICIENT DELIVERY SYSTEM
- DERMATOLOGICAL PRODUCT DEVELOPMENT
– ADOPTION OF NOVEL TECHNOLOGY
+ PK, Chemistry, Biochemistry, Drug Delivery Know-How, & Clinical Basis
- MULTI-LEVEL TREATMENTS
- TREATMENT PRODUCT AND MONITORING SYSTEMS
- WOUND HEALING
- DIAGNOSTIC DEVICES
- PERSONAL CARE PRODUCTS
“BioProduct” is a term coined by Biometrix used to describe the application of basic research to the treatment of skin diseases, wound healing and the diagnosis of localized skin, systemic, environmental and occupational conditions. “BioProducts” applications are deployed in the determination and noninvasive detection of biological and chemical agents, skin conditions, systemic conditions, diabetic wound healing, therapeutic drug monitoring, molecular markers of skin and systemic diseases. They are designed to optimize the treatment of skin diseases and wounds, rapidly detecting agents and diseases through specialized scientific knowledge and technology. Biometrix “BioProducts” are technologically advanced, dedicated to the development of your medical products and devices in the following segments:
- WOUND HEALING
- DIAGNOSTIC DEVICES
Collaborate with Biometrix, your new partner in development!
DELIVERY! Regulatory Approval and Registration
Biometrix will help get your product to the market faster with our Regulatory, Registration, and Advisory Services. Used separately or as needed in any clinical phase; our services include:
- FDA SUBMISSIONS ASSISTANCE
– IND, NDA, IDE, PMA, OTC & COSMETIC NOTIFICATIONS
- INTERNATIONAL REGULATORY FILING SERVICES
- REGULATORY COSNULTING & ADVISORY SERVICES
– LEGAL ISSUES
– INTERNATIONAL DISTRIBUTION
- PRODUCT REGISTRATION ASSISTANCE
– DERMATOLOGICAL, OPTHAMOLOGICAL, CARDIAC, MICROBIOLOGICAL, PHARMACOKINETIC, BIOCHEMICAL & BIOANALYTICAL PRODUCTS
- RISK ASSESSMENTS