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Outstanding Track Record of Product Approval: Over the past 20 years, XTiers principal made significant and direct contributions in five NDA dossiers with all being approved Carbatrol® (1997), Adderall XR® (2001), Fosrenol® (2004), and Equetro® (2004) and Vyvanse® (2007). Extensive Experiences in Clinical Research and with FDA Review Divisions: Services provided through XTiers are deeply rooted in over 20 years of experiences in research and clinical trial design, data collection and integration, statistical analysis, and regulatory interaction and drug registration, with 100 plus Phase 1-4 trials in several therapeutic areas. Professional and Lifetime Services for Small Companies with Limited Resources: XTiers operates in compliance with ICH and FDA guidelines. All deliverables for registration are generated under our standard operating procedures (SOPs), which are at the same level as or above industry average and has been audited by industry expert on behalf of clients. XTiers deliverables were audited at client site by FDA DSI field inspector, with no 483s written. To succeed in today’s number-oriented decision-making process, companies with limited resources need to have continued data and statistical support from committed professionals, just like a family needs a good lawyer or doctor. Costs of at least 50% Below Industry Average: Grateful to the technology advances, XTiers has not only no overhead, but also keeps its bottom-line lean. All of its consultants are also experts in network communication and computer software commonly used in the industry, including SAS, WS Words, Excel, and PowerPoint as well as Adobe Acrobat. It guaranties that any contract-based charges or bids of deliverables are at least 50% below the average cost in the industry. For hourly-based jobs, XTiers provides its clients in advance a fee schedule outlining the maximum billable hours for each defined deliverable, and absorbs any costs after the maximum billable hours is reached. Speed of Multi-Times Faster Than Industry Average: We work round the clock (24 by 7) and, if needed, can be reached anytime and anywhere. For well-defined jobs such as randomization schedule, protocol/synopsis statistics, and CRF review, we deliver within a timeframe of 24 to 48 hours. Comparing to the industry average of 6 months, our record for delivering NDA clinical sections is 3 months from the database lock of the final efficacy/safety study that is included in the dossier. Direct Communication with XTiers Principals Who Do the Job: Clients contact XTiers principals directly, who are the Consultant doing the job and who know well about the type of specifications to ask and the type of deliverables to provide. There is no lost communication and no wasted time. XTiers locates closely to the FDA in Rockville, Maryland. Strategic Alliance to Streamline Product Development: XTiers offers the access to a strategic alliance that has the experience to streamline process, reduce costs, and maximize the success potential for clients. A Special Note to Chinese Pharmaceutical Companies Looking for Overseas Markets: XTiers principals originally came from China and would like to assist Chinese companies to expend into US market. |
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