Alexa Shaping the Future of Drug Development: Cytel

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Shaping the Future of Drug Development: Cytel

Shaping the Future of Drug Development: Cytel

Cytel believes the clinical development of safe and effective medicines is crucial for human welfare. The company’s mission is to improve success rates in this endeavor via the optimal design, effective implementation and accurate data management of clinical trials.

It believes that if you don’t get the trial design right, nothing else matters; and that every sponsor should evaluate the option of an adaptive approach. While Cytel may be best known for its pioneering work in adaptive approaches, our growing clinical research customers rely on Cytel strategic consulting, statistical programming and end-to-end data management expertise.

As the world's largest biometrics CRO, all the major pharmaceutical, biotech and medical device companies are Cytel’s customers along with scores of specialty and emerging sponsor companies. It also counts among our customers and research partners the leaders in academia, at medical institutions and international regulatory agencies.

How it all started

Cytel was founded in 1987 by Cyrus Mehta and Nitin Patel, both Fellows of the American Statistical Association, and both active with the company. The company is led by senior people with extensive experience in clinical development and expertise in biostatistics, operations research, SAS programming, medical writing, data management and software development.

Cytel works hard to create successful careers with significant professional growth for its employees, as a result of which they work hard to make Cytel successful. This, in turn, enables it to make sure its customers are highly satisfied with its software and services.

For Cytel, the customer comes first and profits second. Its customers know it, too. It takes pride that its software for the design and analysis of clinical trials – East®, Compass®, StatXact®, LogXact® - is the industry standard and used also by the FDA. Its products are known for their user-friendliness, detailed manuals, and thorough validation and testing.”

The firm also takes pride that its services customers regard it as partners. Its style of working is collaborative, and its goal is to make them successful by being scientific, rigorous, and thoughtful.

Cytel’s USA, European and India teams have developed a well-integrated way to work on both software and services. As a result, Cytel does its work to the highest standards of quality at a cost significantly lower than its competition. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

Values and Beliefs

Cytel values excellence in implementation, with an emphasis on obtaining the maximum useful information for the money spent and enabling the best decisions to be made about the candidate drug or device.

The company is committed to a collaborative style of working. Committed to helping its customer uphold the highest standards of scientific rigor, statistical validity, and data quality in all its engagements.

Who Cytel works with

All the major pharmaceutical, biotech and medical device companies are Cytel’s customers. Cytel also works well with dozens of smaller biotech and specialty pharma companies throughout the world. It works best with those who want to innovate in clinical development in order to improve success rates.

They also count among their customers and research partners many academic and medical centers, as well as government and regulatory agencies worldwide.

Cytel’s research collaborations have led to the development of innovative scientific methods and cutting edge technology.

Quality First Services

Strategic Consulting: Highly qualified MDs and PhDs, the company’s strategic consultants include quantitative strategists and regulatory, clinical, medical, and health policy experts.

Its track record of supporting complex drug and device development programs spans the regulatory, clinical, statistics, pharmacometrics, data science, and commercial spectrum.

Its people are widely published, internationally prominent thought leaders who collaborate with an extensive network of health professionals from industry, academic institutions, and government bodies.

Most significantly, they are the trusted, ‘go-to’ team for sponsors ranging from the largest pharmaceutical and device companies to small, niche start-ups.

Cytel’s strategic consulting team helps you to optimize your regulatory, clinical, and market access pathways, by identifying appropriate strategies and using data to support the decision-making process at every stage, from concept to commercialization. 

Whether for Rx medicines, medical devices or over the counter (OTC) products, the firm shares your ambition to bring new products to market quickly, efficiently and safely - with the utmost scientific rigor and to the maximum benefit of patients.

Real world and advanced analytics: With digitalization and an abundance of new data sources, drug development is entering a new era with regulators and payers looking to incorporate real-world data to inform decision-making. The company generates evidence that complements traditional randomized clinical trials, accelerates submissions, expands indications and supports health-economic decision-making. Cytel focuses on using sophisticated statistical, decision modeling and data science techniques to generate evidence that regulators and payers will trust.

Joshua Schultz, Chief Executive Officer

Joshua has built and led groups for services spanning the development lifecycle, including study-start up, late phase trials and market access. His achievements include the development of novel approaches to building high value strategic partnerships with life science companies and creating innovative operational models that leverage real world data and related technologies.

Prior to joining PAREXEL, he served as Vice President of Corporate Development at Veritas Medicine, which he co-founded. Previously, he worked at Mercer Management Consulting, where he developed growth strategies for Fortune 500 companies.

Joshua holds a B.S.E. in Finance from the Wharton School of Business, a B.A. in International Relations from the University of Pennsylvania, and a Masters of Philosophy in International Relations from the University of Cambridge, UK.

“Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.”

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