Services

Cytel Software offers services that help biopharmaceutical companies achieve their goals of efficient clinical development. Our services consist of:

• 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

Optimized Clinical Trial Design = Efficient Clinical Trials

Cytel's OCTD consulting services help investigators plan statistically rigorous, efficient clinical trials. We help investigators:

• Fast-track drugs with positive interim results
• Fast-track drugs with high-effect subpopulations
• Stream-line clinical development by reducing time between trials
• Identify and terminate futile studies early
• Eliminate failure due to design-error (underpowered studies)
• Guarantee the power, type-1 error, and statistical validity of the trial
• Defend the statistical protocol for the benefit of regulatory agencies.

Most of Cytel's OCTD work employs interim efficacy analysis. Cytel's experts can demonstrate to you how feasible flexible designs can be. Properly conducted interim analyses increase the sponsor's options and speed go/no go decisions, while only modestly inflating sample size and p-values. But whenever a study design deviates from the standard fixed sample approach, the highest degree of statistical rigor must be applied. All designs should be validated through simulation. The methodology behind the design must be sound and demonstrable to all members of a study team - statisticians, clinicians, and management.

Cytel addresses these concerns through a unique component of the OCTD services: East, Cytel's industry standard software for the design, simulation and interim analysis of flexible clinical trials. East is fully validated and used by every division of the FDA. East's powerful algorithms, specialized statistical routines, and extensive graphics allow for rapid turn-around of multiple design scenarios. When your study is designed with East (either by Cytel or in-house statisticians) the FDA can verify your design using the identical software package.

Contact us to discuss how our experts can increase your study options and speed go/no-go decisions, without jeopardizing the validity or feasibility of your Phase IIb, Phase III or Phase IV clinical trial.

Biostatistics Training

The study design stage is one of enormous leverage for investigators, but only if the study biostatistician can advocate for the right statistical plan. Cytel believes that with the right training and tools, any biostatistics team can contribute to a more efficient clinical development program.

Cytel's staff of distinguished academics has been invited to speak on clinical trial design at numerous workshops organized by groups such as: the FDA, the DIA, the American Statistical Association, the Tufts Center for the Study of Drug Development, the Massachusetts Biotechnology Council, and the Harvard School of Public Health. Cytel has also offered custom training to numerous biopharmaceutical companies.

Topics covered in our half-day, full day, and multi-day workshops can be technical or non-technical in nature, and may include:

• Distribution theory
• Futility, efficacy, and non-inferiority stopping boundaries
• Conditional power and futility stopping
• Spending functions
• Adaptive and Information based designs featuring sample-size re-estimation
• Simulation
• Survival end-point studies
• Hands-on training in East

Contact us to discuss a training program that meets your needs.

Customized Software and Technology Systems

Cytel's award-winning statistical software is appropriate for skilled biostatisticians seeking to analyze data and design and simulate studies. But running optimized, flexible clinical trials in a scalable way requires the support of specialized software and IT systems. Cytel employs a team of programmers in our Cambridge, Massachusetts and Pune, India offices and offers:

• Specialized simulations for complex studies
• Integration of East with eClincal systems, for real-time reporting and double-blind information based studies
• Real-time Dynamic Randomization
• Data Mining

Cytel welcomes the opportunity to speak with you about OCTD consulting, training, and systems development that supports your goals for a more efficient clinical trial program.