Industry Provider Profiles Company Type Services
Frontage keeps your drug development program out in front by offering an extensive range of clinical services:
Clinical study design
Strategic and regulatory consulting
Project management
Monitoring
Clinical data management
Biostatistics
Pharmacokinetic and pharmacodynamic analysis
Quality assurance auditing
Medical writing
Pharmacovigilance
Regulatory submissions
Frontage Clinical Research (formerly known as Advanced Biomedical Research, ABR) professionals have a successful track record of executing and managing Phase I-IIa trials in North America and multi-center trials in China. We conduct trials for innovator and generic compounds in our state-of-the-art 72-bed Phase I-IIa clinical research facilities in Hackensack, NJ, as well as in our 130-bed, hospital-based Phase I-IIa facility in Zhengzhou, China.
Frontage Hackensack, NJ, Clinical Research Center
Our 72-bed, state-of-the-art Clinical Research Center is located in Hackensack, NJ, within 15 miles of New York City. The Frontage facility is situated in an ethnically and socioeconomically diverse region, close to a major medical center and within easy traveling distance of major airports and other transportation. Among the trials we perform are:
First-in-human
Dose escalation
Repeated dose
Proof-of-concept
Pharmacokinetic
Pharmacodynamic
Bioavailability
Bioequivalence
Fed-fasted
Drug-drug and drug-alcohol interactions
Frontage also has significant experience performing studies in targeted patient populations, such as those for cardiovascular, metabolic, osteoarthritic, urologic and dermatologic disorders, as well as studies involving pre- and post-menopausal women, men and women with obesity and metabolic syndrome and men with low testosterone.
Frontage Zhengzhou, China, Clinical Research Center
Our 130-bed, hospital-based Clinical Research Center is located in Zhengzhou, China, approximately a one-hour flight from Beijing. The Frontage Clinical Research Center was opened in 2009 and resides in the First Affiliated Hospital of Zhengzhou University, a 6,000-bed facility that is considered one of the top hospitals in China.
Frontage’s China Clinical Research Center operates under the same standard operating procedures as the Clinical Research Center in the United States. Additionally, the research staff and leadership team have all received their training in the United States. The capabilities of the China Clinical Research Center include:
First-in-human
Dose escalation
Proof-of-concept
Bioavailability
Bioequivalence
Pharmacokinetic
Pharmacodynamic
Fed-fasted
Drug-drug and drug-alcohol interactions
Pharmacokinetic (PK) Evaluations
An integral part of any Phase I program is the PK data analysis. Frontage statisticians can offer non-compartmental, compartmental and, if needed, population PK analyses using industry recognized, state-of-the-art software. These analyses can be coupled to statistical analyses performed following FDA guidance to demonstrate bioavailability or bioequivalence of drugs. Frontage has a great deal of experience incorporating pharmacodynamic endpoints into Phase I studies to generate proof-of-concept data.
Data Management
Frontage uses Oracle Clinical™, a state-of-the-art, validated data management system, and complies with 21 CFR Part 11 Electronic Records regulations. Our team also has experience with Clintrial™ and etrials QuickStudy Capture™.
In addition to a manual clinical review of case report forms prior to data entry, customized electronic edit checks are built into each database. Independent double-key data entry is performed and a complete audit trail is maintained for all data entries, corrections and clarifications and all data query reports and resolutions. Key efficacy and safety variables are verified against the case report forms.
Statistical Analyses
Proactive involvement of our biostatisticians results in the efficient and accurate collection, analysis and interpretation of clinical study data. Our biostatisticians take part in prospectively defining study objectives and selecting the most appropriate study design, inclusion criteria, sample sizes, clinical endpoints and statistical analyses.
Medical Writing
A key element of keeping your compound out in front of the competition is effectively assembling the data and providing the pertinent interpretation of the study results. Our medical writing team is comprised of experienced clinical scientists/medical writers who are skilled at data interpretation and the clear and effective communication of scientific data. You benefit from writers who possess extensive knowledge of the pathophysiology and treatment of diseases, as well as the ability to rapidly assimilate new scientific information for novel technologies.
For clinical study reports and regulatory submissions, Frontage uses an integrated, multidisciplinary, project team approach, including key members from the sponsor and investigators or outside experts where applicable. This team meets on a frequent basis from project initiation to completion.
In addition to their clinical research expertise, a number of our clinical scientists also have discovery and preclinical research experience and have established productive working relationships with analytical chemists, toxicologists, pharmacologists and physician researchers, allowing us to offer an integrated approach to the preparation of regulatory submission documents.
If you are interested in participating in a study at our Hackensack, NJ clinic, please contact Frontage at 888.227.9499 for additional information. Our study coordinators will explain the studies that are currently enrolling subjects and answer any questions you may have to determine if you meet the criteria for a given study. If you are eligible for a study based on an initial phone screening, you will be invited to visit the research facility for a screening visit. You will be asked to review and sign an informed consent form before any study procedures are performed. This consent form explains the details of a specific study and any potential side effects of the medication(s) administered during the study. Based on the results of the screening visit, you may be eligible to enroll in a particular study. You can receive more information by registering online at our website
www.frontagelab.com
and filling out the studies subject registration form, and we will contact you.
Our regulatory consulting group provides scientific and regulatory consulting services to clients for their clinical drug research and development programs. Our consulting team facilitates the planning and strategy of regulatory submissions so that reviews are completed in a manner that facilitates approvals. Our team can provide in-depth consulting for regulatory submissions such as INDs, NDAs, BLAs and ANDAs, as well as directly interface with the FDA for preparation and compilation of various submission dossiers and meeting packages.
We understand drug research, development and regulatory approval processes and can help you to advance your drug candidates from preclinical research to clinical development, navigating through the regulatory approval process. Our experienced team is led by a former FDA officer with extensive clinical pharmacology experience (6 years in CDER and 6 years in industry).
Clinical pharmacology regulatory consulting services include, but are not limited to the following activities:
Providing scientific and regulatory consultation on clinical pharmacology and biopharmaceutics portion of the drug research, development and registration plans
Developing clinical pharmacology strategies/plans based on preclinical packages, overall clinical development plans, current scientific knowledge and applicable regulatory requirements
Identifying and addressing clinical pharmacology and biopharmaceutics requirements/issues for drug development and approval
Writing clinical pharmacology and biopharmaceutics portions of regulatory submissions
Contributing to clinical pharmacology study protocol development, data analysis and study result interpretation
Representing clients for communications with the FDA on clinical pharmacology and biopharmaceutical issues
The clinical pharmacology and biopharmaceutics information that our team supplies includes, but is not limited to:
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Exposure-response (PK/PD) relationships, dose finding/selection
Proof-of-concept
Intrinsic factors such as demographics, pharmacogenomics, renal and hepatic impairment and disease states
Extrinsic factors such as drug-drug interactions and food effects
Bioavailability and bioequivalence (BA/BE) studies
Lisa E. Diamond, PhDwww.frontagelab.com View Map Contact Company
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