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Cytel Pharmaceutical Research Services
Designing and Monitoring Efficient Clinical Trials
Science is on the brink of profound new discoveries in medicine and biotechnology. At no time in history has the promise of new drugs and breakthrough treatments for human suffering been greater than it is today. And never have the stakes been higher.
At the same time, the pharmaceutical and biotech industries are under increased public and private scrutiny for the processes by which new treatments are developed, approved and brought to market.
The demand for high ethical standards on the parts of both the industry and government regulatory agencies, coupled with equally strident demands for rapid development and approval of new treatments, puts enormous pressure on those responsible for designing clinical trials and analyzing their results.
The clock is ticking on your precious patent-protected time-window
The financial stakes are enormous. Poorly designed or administered clinical trials can slow down your time-to-market, thus adding to your development costs. They can also eat up precious time on your patent protection, thereby considerably reducing long term earnings potential and profitability.
The ability to stop clinical trials early when the drugs are being determined to be ineffectual or unsafe has also proven to be of enormous ethical and economic value.
In this highly charged economic and political atmosphere, your company needs access to a reliable, technologically astute and highly ethical source of clinical trial design, process and analysis expertise. Cytel’s iClinical Services can be that solution.
iClinical Services
i Clinical Services include full range of clinical trial consulting, design and analysis services:
- Optimized Clinical Trial Design (OCTD): statistics planning for Phase IIb - IV clinical trials
- Adaptive, information based and group sequential (flexible) clinical trials
- Regulatory guidance
- Biostatistics training for statisticians and clinicians
- Technology systems for conducting flexible clinical trials
Benefits of outsourcing your clinical trial design
Employing in-house resources to provide clinical trial design and statistical analysis services is expensive, hard to administer, and can lead to discontinuity within and across projects.
iClinical Services’ client-dedicated teams are a flexible, cost-effective way to help you develop and introduce your vital new drug therapies while freeing your in-house resources to focus on core technologies and strategic application development.
Our well-developed project management processes and 100% Cytel-owned infrastructure provide you with high quality programming and analytical resources at all stages of your clinical trials process. You are assured of rapid project turnaround time, complete confidentiality of data and significant reduction in costs.
Reports from external independent statisticians are more likely to be viewed by the FDA as confirming your company's analysis. External statisticians have more flexibility in meeting the requirements of Data Safety Managing Boards without the appearance of possible compromise or influence by management.
Speed and efficiency is increased because our statisticians are highly focused and work within a well-established system. Clinical trial data analysis is all they do. Typically, the iClinical Services team can create in weeks a report that could take in-house statisticians a month or more.
Who We Are
iClinical Services is part of the Cytel Software and Services organization. Since its founding in 1987 by Harvard Professor Dr. Cyrus R. Mehta and MIT Professor Dr. Nitin R. Patel, Cytel has become the gold standard in the application of advanced computational statistical analysis to the design and optimization of clinical trials.
For the first time, biostatisticians have an accurate and dependable way to facilitate early termination of futile studies and unsafe treatments, sample-size adjustment, and interim monitoring for administrative purposes.
Today, Cytel is a world-recognized thought leader in adaptive and flexible clinical trial design. Our FDA-approved software is considered the industry standard and is used by more than 15,000 customers worldwide – including every major branch of the FDA.
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