June 28, 2022
Founded in 1987 by Cyrus Mehta and Nitin Patel, research scientists at Harvard University and MIT respectively and...
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April 12, 2022
In this edition of the Career Perspectives series, I interview Charles Warne, Associate Director of Biostatistics at...
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March 8, 2022
The issue of delayed treatment effects in immuno-oncology was demonstrated during a FDA-Industry sponsored workshop...
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August 18, 2021
During the design of a clinical trial, many biotechs want to substantially reduce the risk of a good new therapy being...
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August 13, 2021
With the cloud computing power that we have today, we can run simulation of 1000s of designs with each design...
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July 28, 2021
“We found an optimal design in hours that might have taken months to find using standard methods,” reflected Fabien...
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July 22, 2021
Earlier this year, Cytel founder Cyrus Mehta observed that clinical trial design is often treated like an art rather...
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July 14, 2021
For decades, statisticians have cultivated methods to optimize and de-risk clinical trials for strong regulatory...
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July 7, 2021
Suppose a statistician were to tell a clinical trial sponsor that it was possible to improve the power of the sponsor’s...
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May 19, 2021
Clinical trial sponsors are more likely than ever to use the power of simulation and forecasting to evaluate the...
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May 7, 2021
When is a study design considered to be optimal? A good design performs well not only under the ideal target scenario...
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April 28, 2021
Recently, Cytel co-founder Professor Cyrus Mehta noted that, “Clinical trial design selection is too much like an art,...
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April 20, 2021
For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea...
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March 19, 2021
The use of wearable and digital technology requires considerations for both drugs and devices regulations, and...
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March 18, 2021
Over the past ten years High-Performance Computing (HPC) has transformed medical research through advances in genomics,...
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March 12, 2021
With wearables likely to become a regular part of clinical trial design, statisticians could benefit by familiarizing...
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February 26, 2021
In the world of clinical trials, the pace of innovation is accelerating, and approaches such as Bayesian methods are...
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February 25, 2021
The convergence of several distinct trends has made wearables an increasingly attractive option for use in confirmatory...
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February 11, 2021
The past two years have witnessed a heightened interest in the use of wearables in clinical development. The unexpected...
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January 26, 2021
Bayesian models offer a flexible way of incorporating historical controls in the analysis of trial data (whether single...
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January 19, 2021
As we enter 2021 with new COVID-19 vaccines and greater optimism about the pipeline of drugs and devices positioned for...
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January 13, 2021
Effective use of the right outsourcing solution can enable sponsors to respond to market needs and change course where...
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December 22, 2020
At Cytel, we have been diligently working to become an organization deeply committed to uplifting and enriching...
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December 17, 2020
As Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation...
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December 15, 2020
When designing clinical trials, biostatisticians and clinical development teams are often faced with a conundrum. Given...
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December 10, 2020
Sachin Sobale began his career with Cytel as a young statistician. He has been associated with the company for more...
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December 9, 2020
As a part of Cytel’s Advanced Design Framework, a new Framework for the statistical design of clinical trials, Cytel...
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December 3, 2020
Increasing Clinical Development Productivity Using Statistics and Cloud-Computing The need for Re-imagining Clinical...
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November 18, 2020
The current state of the clinical trials industry faces a challenge that was only hypothetical three or four years ago....
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November 11, 2020
The widespread use of cloud-computing has altered the clinical trial design process. Whereas three or four years ago,...
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November 4, 2020
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on...
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October 29, 2020
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought leaders that draws on...
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October 26, 2020
Pharmaceutical and biotech companies are under pressure to deliver more and deliver faster with fewer resources. The...
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October 21, 2020
Cytel has recently revealed its Advanced Design Framework, a method developed by Cytel’s thought-leaders after a decade...
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October 13, 2020
The combination of greater access to electronic health records, bigger electronic claims datasets, and the need for...
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October 1, 2020
Methods involving Group Sequential Designs are one of the earliest deviations from a traditional two-arm clinical trial...
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September 17, 2020
Keeping up with the rapid pace of clinical development means that we need to adopt the innovative or computationally...
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September 15, 2020
In clinical trials with small or sparse data, statistical methods meant for large sample sizes may not be helpful to...
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September 9, 2020
Cytel’s co-founder, Nitin Patel, conducted a webinar on designing clinical trials from a program-level perspective. His...
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September 1, 2020
In this blog, Cytel's SVP Corey Dunham’s talks about our Functional Services teams and the qualities we seek in new...
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August 31, 2020
Pantelis Vlachos, Principal, Strategic Consultant at Cytel, conducted a webinar to introduce the capabilities of East...
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August 26, 2020
As Chief Scientific Officer, Dr. Yannis Jemiai plays a pivotal role in maintaining Cytel’s well-established reputation...
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August 25, 2020
It is important to take a strategic approach to clinical development in order to minimize the potential for Phase 3...
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August 12, 2020
Cytel’s Biostatistics and Statistical Programming team provides integrated solutions, by blending the expertise of...
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August 4, 2020
Last year, Paul Terrill, Associate Principal of Strategic Consulting at Cytel, presented an engaging webinar on the...
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July 27, 2020
Cytel is conducting a webinar series on complex innovative trial designs. Dr. Thomas Burnett, Senior Research Associate...
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July 22, 2020
Cytel brings to you a new blog series on technology and Bayesian decision-making by Pantelis Vlachos,...
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July 13, 2020
Cytel is hosting a complimentary webinar series that introduces biostatisticians and other members of the development...
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June 10, 2020
Cytel is conducting a webinar series that introduces biostatisticians to some of the more commonly used complex...
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May 27, 2020
In this blog, we speak with Christopher Jennison, Professor of Statistics at the University of Bath, UK. Professor...
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April 27, 2020
In the first part of this two-parts blog, I speak about how the European CDISC Committee (E3C) together with CDISC...
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April 24, 2020
In early March, when countries around the world started implementing lockdowns, the European CDISC Committee (E3C)...
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March 5, 2020
Generating high-quality clinical data is a vital but challenging task in modern drug development. Unfortunately, in the...
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February 20, 2020
It is widely acknowledged among drug developers that one of their most important assets is the data generated during...
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November 5, 2019
Cytel is delighted to have Kannan Natarajan speaking at the “Complex Innovative Trial Design Symposium and East User...
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January 10, 2019
Nand Kishore Rawat is a Director and Head, Early Phase Biostatistics based in the King of Prussia, PA Cytel office. We...
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December 5, 2018
In this blog, Paul Terrill, Director of Strategic Consulting at Cytel outlines his blueprint for ensuring smooth...
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November 12, 2018
In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming...
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October 5, 2018
We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In...
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September 20, 2018
At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking...
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September 17, 2018
Immunotherapy has brought us many promises, most notably, of a future where humans are able to harness their body’s own...
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September 10, 2018
The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety...
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September 7, 2018
On August 29th 2018, the FDA announced (1) that it would be establishing a Complex Innovative Trial Design (CID) Pilot...
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August 31, 2018
JSM 2018, ASA’s annual gathering of over 6500 attendees attracted statisticians and data scientists to the beautiful...
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August 23, 2018
Cytel has grown significantly over the last 30 years, with operations across North America, Europe, and India. All of...
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July 24, 2018
At Cytel our strategic consulting team works on a wide range of projects including: Identifying the best clinical trial...
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July 2, 2018
A number of the Cytel team were in Amsterdam, 3rd- 6th June 2018 for the PSI Conference. This year’s conference was...
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May 23, 2018
Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic...
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May 16, 2018
Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic...
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May 9, 2018
As we prepare to head to ASCO in under a month's time, we are pleased to share a new ebook that showcases some key...
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April 18, 2018
Our recent Clinical Biometrics Survey explored the views of respondents from across the statistical programming,...
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March 16, 2018
At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking...
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February 15, 2018
A recent publication in Biometrics ‘A Gatekeeping Procedure to Test a Primary and a Secondary Endpoint in a Group...
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February 13, 2018
Our strategic consulting team work on projects such as: Identifying the best clinical trial design, implementing...
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November 9, 2017
In this blog we are excited to unveil a new project which we have been hard at work on over the last few months. 2017...
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September 29, 2017
Namrata Deshpande, Senior Team Lead will be participating in a round table discussion at the Women in Statistics event...
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September 20, 2017
In this blog we share a case study of work our strategic consulting team conducted supporting accurate event prediction...
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September 18, 2017
By Ashwini Joshi For small sample data or rare events data, exact non-parametric tests perform better than asymptotic...
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September 13, 2017
Antibiotic resistance is one of the greatest challenges facing human health today. We are excited to welcome Dr. Scott...
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September 11, 2017
At the East User Group meeting (EUGM) on 25th and 26th October, we will welcome a number of renowned industry speakers...
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August 2, 2017
As a biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and...
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July 26, 2017
Sadly, clinical development of anti-cancer therapeutics faces particularly high rates of failure, even in the context...
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July 19, 2017
With adaptive and innovative trial designs on the rise, operational implementation of interim analyses, including...
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July 13, 2017
By Tejasweeni Rajput It’s been known for centuries that a picture can tell a thousand words. In an era of new...
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July 11, 2017
The Adaptive Designs and Multiple Testing Procedures Workshop (ADMTP), the first joint meeting of the Adaptive Designs...
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July 6, 2017
By Esha Senchaudhuri The ethical benefits of adaptive clinical trials have been widely acclaimed: higher prospects for...
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June 28, 2017
About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management,...
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June 12, 2017
The Population Approach Group in Europe (PAGE) represents a community with a shared interest in data analysis using the...
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June 8, 2017
Cytel's Madhusmita Panda presented at this year’s PSI Conference in the Innovative Methodology session on the topic of...
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May 30, 2017
A recent paper The case for Bayesian methods in benefit-risk assessment: Overview and future directions (1) co-authored...
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May 26, 2017
PharmaSUG 2017 proved to be an inspirational and informative event. With over 200 paper presentations, posters, and...
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May 22, 2017
James (Jim) Bolognese, Senior Director, Strategic Consulting, Clinical Services at Cytel Inc. was named a 2017 fellow...
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May 17, 2017
This new case study shares how Cytel supported a specialist biopharmaceutical company from Phase 2 trial design through...
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April 28, 2017
In this blog we share a case study in which our statistical consulting team helped a client redesign an oncology...
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April 25, 2017
At a recent conference Adam Hamm, Director Biostatistics at Cytel, presented his thoughts on Best Practices and...
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April 11, 2017
In a January 2017 paper (1), the FDA reviewed 22 case studies where promising Phase 2 trials did not result in...
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April 5, 2017
Statistical programmers at all levels can make a significant impact on streamlining delivery, improving efficiency, and...
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March 29, 2017
With an increasing interest in platform designs and other innovative designs that involve multiple comparisons over...
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March 24, 2017
Robust go/no-go (GNG) decision-making is essential for effectively managing risk across a clinical portfolio. In early...
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March 20, 2017
In the randomized clinical trial (RCT), the process of deciding the randomization method and implementing is critically...
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March 10, 2017
At the recent Biosimilars Summit in Philadelphia, Cytel's Pantelis Vlachos presented on statistical challenges and...
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March 2, 2017
We continue our case study series with this example of a Phase 3 design that uses Bayesian decision making combined...
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February 27, 2017
It’s been hard to miss the prevalence of estimand-related discussions in the last year. This is a topic which is very...
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February 21, 2017
In a previous blog, we provided an overview of basic data structures in R. In this follow up piece, we will provide a...
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February 15, 2017
Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may...
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February 9, 2017
In this blog, Adam Hamm, PhD, Director Biostatistics at Cytel shares some of the most important knowledge he uses in...
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January 30, 2017
Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies. They...
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January 23, 2017
As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for...
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January 19, 2017
R is on the rise in biopharma, and as we have previously discussed on the blog, it is now time for SAS programmers to...
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January 16, 2017
The Global Cardiovascular Clinical Trialists Forum is a key event bringing together leading experts from across the...
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January 5, 2017
Nonlinear Mixed Effects Modeling (NONMEM) is a type of population pharmacokinetics/pharmacodynamics (popPK/PD) analysis...
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December 15, 2016
In April, we interviewed NIHR research fellow Munya Dimairo about the paper, ‘Adaptive designs undertaken in clinical...
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December 2, 2016
At a recent Pfizer/ Cytel seminar on rare disease and oncology development, Cytel’s Lingyun Liu presented innovative...
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November 18, 2016
Challenge Our client had the following key questions which they wanted our pharmacometrics group to address for an...
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November 14, 2016
In our last blog, we shared some of Angelo Tinazzi and Cedric Marchand's recommendations on how to ensure independence...
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October 5, 2016
While some progress has been made in terms of scientific development in Neuroscience and Neuropsychiatry indications,...
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September 13, 2016
Exposure-response data gained from clinical studies can provide a basis for model-based analysis and simulation,...
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September 9, 2016
Challenge: Our client, an emerging biotechnology company, was preparing for the next stage of development for their...
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August 31, 2016
Traditional rule-based approaches to dose escalation such as 3+3 are widely used in early clinical development. They...
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August 26, 2016
At the recent JSM in Chicago, Cytel’s Sam Hsaio and Lingyun Liu alongside Genentech's Romeo Maciuca, presented a...
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August 23, 2016
At the recent JSM meeting in Chicago, Cytel's Jim Bolognese presented the results of work he has conducted evaluating...
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August 17, 2016
Following the recent publication of their review article Adaptive Designs for Clinical Trials in the New England...
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August 9, 2016
At the recent JSM Meeting, Cytel’s Yannis Jemiai presented the case study of the VALOR trial which used a promising...
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July 18, 2016
In order for adaptive designs to reach their potential, it’s critical that knowledge is effectively dissemirnated...
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July 7, 2016
Why do we do what we do? At Cytel we have always been driven to deliver benefits in the service of human health, and...
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June 21, 2016
Sunil is an Associate Director of Statistical Programming at Cytel and has over twenty-five years of experience in the...
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June 14, 2016
At Cytel, we are very often asked to get involved in DMCs ( Data Monitoring Committees) in a variety of capacities. Our...
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June 7, 2016
At the recent CMO Summit East James ( Jim) Bolognese, Cytel’s Senior Director of Strategic Consulting, and Lou...
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May 31, 2016
Last week, we were delighted to announce the release of East 6.4 bringing further cutting –edge approaches to the East...
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May 19, 2016
The explosion in healthcare information and “big data “has been one of the most written about topics in the last few...
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May 17, 2016
Cytel participated at PharmaSUG 2016 in Denver recently. A key event on the statistical programming global calendar,...
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May 10, 2016
We were fortunate to welcome Björn Bornkamp of Novartis to the EUGM 2016 presenting work he has developed jointly with...
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