7 Reasons to Add a Statistical Consultant to Your Team

Posted by Cytel Consulting

Oct 14, 2014 11:05:00 AM

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We are often asked how statistical consultants can add value to the clinical development process. What do they contribute to a winning strategy, and how do they optimize business decisions? 

Statistical consultants often have decades of experience in multiple aspects of clinical development, including trial design, portfolio optimization, and regulation. Having a broad and yet nuanced feel for the industry enables statistical consultants to generate novel solutions to an array of challenges faced while navigating clinical development.

If you are thinking of hiring a statistical consultant to your team, you should be aware of the many roles that they can play. Here are some of our consultants' favorite recent projects. 

  1. Building a clinical development strategy: By evaluating alternative clinical development strategies, we spared our client an unnecessary study, many millions of dollars, and 6-9 months of development time. 

  2. Preparing a robust regulatory strategy: Drawing on decades of experience, we successfully guided our client in defending its innovative clinical development strategy in front of regulators.

  3. Balancing competing goals: Working as an integral part of the client team, we devised a customized utility function that combined safety and efficacy objectives to better measure the success of their drug.

  4. Improving information quality: In implementing an adaptive dose-finding study, we helped our client learn more about their asset and maximize its market value.

  5. Providing insightful analysis: By applying signal detection techniques to our client’s data, we developed classification algorithms to help them identify target patient subpopulations.

  6. Securing investment capital: A novel adaptive confirmatory trial helped one of our small biotech clients secure otherwise unavailable funding in a risky therapeutic area.

  7. Delivering with efficiency: Rallying behind a specialty pharmaceutical for its first Phase 3 study, we combined our design and biometrics services to help secure regulatory approval within a year. 

Want a statistical consultant on your team? 

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Related Items of Interest

 

Adaptive Designs for Financial Program & Portfolio Optimization

Why Using Adaptive Designs Can Attract Investors to Your Trial 

To Adapt or Not to Adapt? 10 Simple Steps to Deciding Whether Your Next Trial Should be Adaptive

Impact of Study Design and Development Strategy on Pharmaceutical Programs & Portfolios

Beyond Borders: Biotechnology Industry Report 2014 (Ernst & Young) 

 

Adaptive Designs

Cardiovascular Outcome Trials

Adaptive Designs for Risk Based Monitoring

Seamless Adaptive Designs: The ADVENT Trial

Empirical Study Confirms Positive Impact of Adaptive Designs

Why Adaptive Sample Size Re-estimation Preserves Type 1 Error

Topics: Data Management, Cytel Strategic Consulting, Cytel Consulting

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