Company
CRO
Amarex is a full service Contract Research Organization (CRO) that provides clinical regulatory strategy and product development services for drug, medical device and diagnostic kit approvals in the U.S. and other countries.
Amarex's Turn-Key Development Capability
Clientele
Amarex clients come from around the world and range from small start-up companies to some of the world's largest Pharmaceutical firms. The majority of Amarex's clients are small and mid-sized companies, and all are treated with equal respect and attention.
Amarex Advantages
Amarex offers more than capable hands. We are a consultative group of clinical researchers, always ready to go out 'on the limb' and give our own recommendations for solving the challenges clients face over the course of a clinical development program or single trial. And of course we stand behind our recommendations by putting them into action ourselves through our CRO services.
Amarex's modest size, flat organizational structure and highly qualified staff assure that every project is guided by very experienced clinical researchers.
Amarex's corporate culture of interdepartmental cooperation and central location of key staff improve both trial performance and responsiveness to clients' needs.
We are also very conscientious of our clients' budgets and work with them to develop budgets that accurately reflect the number of hours requested and the full scope of work to be performed.
Clinical Trial Efficiency and Performance
- Amarex's expert clinical operations staff ensures efficient, trouble-free study execution.
- Parallel processing, properly implemented, reduces trial closeout time and improves overall trial performance, thereby reducing costs.
- Amarex's clinical trial management system, WebViewSM, provides ongoing, online access to study data and performance metrics to help project teams monitor trial progress and aid clients' decision making throughout the trial.
- Senior management's hands-on involvement ensures your study has oversight from our most experienced, knowledgeable staff — and rapid access to extra resources as needed.
- Use of current, proven research technologies – EDC, online CTMS, e-patient diaries, etc. – are applied to maximize efficiency, accuracy, compliance and security.
Parallel Processing Method
Amarex applies true "Parallel Processing" to the conduct of clinical trials. This is a method of trial conduct in which many tasks across the full spectrum of regulatory, clinical, biometric and writing services are conducted in parallel. It results in reduced trial closeout time and, more importantly, improved trial performance to further ensure successful outcomes.
- Database lock approximately 3 weeks after last patient out
- Statistical analysis within 24 hours of database lock
- First draft of the Clinical Study Report as early as 2 weeks after database lock
FDA Interactions
Amarex's two principals each have more than 25 years of clinical research experience in industry, FDA, and academia. In the course of those years they have represented their own pharma companies and client companies many, many times in all types of FDA meetings.
- Pre-submission meetings
- End of Phase II meetings
- Advisory Committee presentations
- Regulatory consults
WebViewSM - Amarex's Online CTMS
- Patient Enrollment and Randomization
- CRF, DCF and Regulatory Document Viewing
- Trial Status Reporting
- Tables & Listings Review
- SAE Processing
- Drug Re-supply
- Study Bulletin Board