July 27, 2022
Written by Jing Ping Yeo and Charles Warne Adaptive designs are studies that “include a prospectively planned...
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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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March 18, 2022
Real world evidence (RWE) provides a large and growing source of insights into drug uptake and safety. It is...
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March 11, 2022
Every year, sponsors hesitating to use a complex innovative clinical trial design routinely miss opportunities to...
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February 18, 2022
Data is the most crucial asset of any clinical trial and hence, sponsors cannot jeopardize collecting clean...
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February 11, 2022
Adopting data standards such as CDISC in the early phase of clinical drug development contributes to the consolidation...
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February 4, 2022
The ability to conduct data-driven and quantitatively rigorous feasibility studies, is often key to successful trial...
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December 23, 2021
Cytel blogs bring you debate and discussion of the newest trends in statistics and quantitative strategy. In 2021, our...
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December 14, 2021
In traditional clinical trial design, the sample size is often determined to detect the target treatment effect with...
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April 29, 2021
After twenty years in pharma, Anna Forsythe was frustrated by traditional vendors who used outdated methods to prepare...
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April 26, 2021
As we all continue to take necessary precautions against the spread of COVID-19 virus, this year again the CDISC EU...
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March 31, 2021
As decentralized clinical trials become more attractive in an era of COVID-19, the role of wearables in clinical...
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March 30, 2021
As of today, our Industry has not defined any approach, nor does an official regulatory agency...
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March 26, 2021
Former Commissioner of the FDA, Dr. Scott Gottlieb, in several public presentations, would bemoan missed chances to...
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March 25, 2021
Wearables have experienced increasing applicability within medical device trials, yet the regulations for the use of...
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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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March 11, 2021
In the recent years, Oncology trials are seeing a technological shift that is expected to make them faster and more...
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March 9, 2021
When statistical sciences were in their infancy, the communicative benefits of statistics were widely touted. Thousands...
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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 24, 2021
In a previous post, I discussed the importance of proper use of CDISC Controlled Terminology (CDISC CT) in SDTM....
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February 19, 2021
C-Suite and R&D Decision-Makers are always striving to make evidence-driven decisions. Yet the rules by which evidence...
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February 17, 2021
The COVID-19 Pandemic prompted the rapid surge in the generation of clinical data that has been scattered across...
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February 12, 2021
In recent times, Single arm trials are being increasingly used to assess new treatment interventions. They establish...
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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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February 4, 2021
The past decade has witnessed the rise of simulations-based clinical trial optimization in a manner unimaginable to...
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February 2, 2021
As the use of master protocols becomes more prevalent in drug development, Bayesian methods are extensively used to...
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February 1, 2021
Cytel’s COVID-19 Trial Tracker continues to provide real time updates to the status of COVID-19 clinical trials...
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January 29, 2021
Historically, advances in the statistical design of clinical trials have accompanied progress within the science and...
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January 28, 2021
The Christmas break presented an opportunity to make my first concrete steps into the CDISC Library. Overall, it was a...
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January 22, 2021
COVID-19 has transformed the pharmaceutical industry in a manner that few could have predicted only a year ago. One of...
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January 20, 2021
One of the most difficult challenges facing Research and Development teams involves determining how to make tradeoffs...
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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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January 12, 2021
The rapid pace of technology has opened up numerous avenues for advanced innovative clinical trial design, but how can...
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January 11, 2021
In April 2020, Cytel launched an open-access global COVID-19 Clinical Trial Tracker to help facilitate greater...
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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 21, 2020
2020 has been an unusually difficult year as the global pandemic impacted all of our lives. This year, the Cytel blog...
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December 18, 2020
Can I submit software programs other than SAS? What software programs should I submit? Are sponsors required to submit...
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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 16, 2020
As we prepare to close the door on 2020, we asked Pantelis Vlachos, Principal/Strategic Consultant for Cytel, to share...
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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 8, 2020
The Cytel COVID-19 Trial Tracker brings you an up to the minute, real time dashboard about COVID-19 trials around the...
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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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December 1, 2020
An extraordinary amount of global research is underway as the COVID-19 pandemic continues to evolve and spread. As...
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November 24, 2020
Virtual ISPOR 2020, held November 16 to 19, presented new opportunities for scientific interaction amongst HEOR...
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November 23, 2020
The Virtual PHUSE-EU CONNECT Conference was held from November 8 to 13 and the event was a great success, despite all...
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November 19, 2020
Data Monitoring Committees (DMCs) are groups of independent experts who periodically receive (by-arm) reports created...
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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 17, 2020
As a part of Cytel’s "New Horizons Webinar Series", Alind Gupta, Senior Data Scientist, presents case studies from his...
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November 16, 2020
MUCE is a Bayesian solution for cohort expansion trials where multiple dose(s) and multiple indication(s) are tested in...
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November 12, 2020
Cytel and Ingress Health (now a Cytel company) will be contributing to a range of events at Virtual ISPOR EUROPE 2020,...
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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 5, 2020
In oncology, many manufacturers go into niche indications, where there are very specific tumors, and then they opt for...
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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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November 3, 2020
When an expert statistician is paired with an experienced set of data managers, opportunities to capitalize on...
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November 2, 2020
Measuring treatment effect during a clinical trial is often the source of much debate, particularly during rare disease...
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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 28, 2020
About three years ago, Cytel was helping a sponsor on a project where I had to conduct surveillance of some CRO...
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October 27, 2020
Cytel recently conducted a webinar on Bayesian Dose-finding Designs for Modern Drug Development, presented by Dr. Yuan...
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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 23, 2020
Cytel’s New Horizons Webinar Series introduces you to the latest innovations in statistical trial design. This webinar...
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October 22, 2020
In this two-part blog series, we interview Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel...
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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 20, 2020
In this interview with Thomas Wilke, Principal Scientist at Ingress-Health (a Cytel company), we talk to him about his...
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October 19, 2020
COVID-19 has created extreme uncertainties -- a dearth of historical information combined with the need for safety,...
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October 15, 2020
For over a decade, advanced trial design techniques have promised efficient trials with accelerated timelines,...
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October 14, 2020
A credible evidence base is needed to support and document the economic value of new technologies and therapeutic...
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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 12, 2020
Cytel and Novartis are together hosting a complimentary Bayesian Virtual Symposium and an Interactive 7-part workshop....
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October 7, 2020
With the rise in digital technologies, there has been an explosion in the volume and type of data sources. We can...
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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 29, 2020
Innovation in trial designs are offering new routes forward for organizations of any size. They are now also aligned...
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September 25, 2020
Regulators in both the United States and Europe have responded positively to the use of synthetic control arms (SCA)s...
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September 22, 2020
Research Scientists, Thomas Wilke and Sabrina Mueller recently published a manuscript on “Diabetes-Related...
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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 16, 2020
Synthetic control arms (SCA) are virtual trial arms that use historical claims data and observational data to simulate...
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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 14, 2020
“A good start is half the battle” (the Before) when submitting data to the FDA and there are a couple of cherries to...
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September 10, 2020
Single arm trials are emerging as an accepted way of assessing a new treatment intervention. They establish clinical...
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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 4, 2020
On Friday September 11, Cyrus Mehta, co-founder of Cytel, will be delivering a talk to the Heart Failure Collaboratory,...
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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 21, 2020
As uses of real world data become more familiar for trial design and regulatory submission, sponsors might become more...
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August 18, 2020
Mrudula Joshi joined Cytel in July 2005 as a young SAS programmer. Last month, she celebrated her 15th year work...
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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 11, 2020
While there is increasing optimism about the discovery of a COVID-19 vaccine, one of the less talked about aspects of...
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August 7, 2020
Recently a biotech approached Cytel for support with a Phase 2 Study in oncology. Regulators had requested a natural...
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August 5, 2020
Cytel is conducting two pilot projects on head-to-head comparisons using real world data. These projects in oncology...
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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 30, 2020
A new peer-reviewed article co-authored by several Cytel scientists re-examines the way in which adaptive trials are...
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July 28, 2020
CDISC standards have been around for a while with the first SDTM Standard version released in 2004. However, it was...
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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 23, 2020
Just as there are numerous adaptations that fall within the umbrella of adaptive designs, there are several different...
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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 15, 2020
Unlike many therapeutic areas, oncology benefits from having standardized endpoints like overall survival and...
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July 14, 2020
Cytel SVP Corey Dunham’s inaugural post on leading the industry’s largest Biometrics CRO considers the FSP Engagement...
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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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July 9, 2020
There has been an increased use of synthetic control arms for regulatory submissions in recent years, with three rare...
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July 7, 2020
Having its roots in the seminar rooms of the Dana Farber Cancer Institute, Cytel has a long record of establishing new...
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June 29, 2020
From the time the COVID-19 outbreak was declared a pandemic, the number of studies conducted around the world to either...
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June 27, 2020
Expert statisticians at Cytel have spent the past three and a half months designing and deploying dozens of trials for...
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June 22, 2020
Cytel scientists recently published a new eBook on synthetic control arms and a new scientific primer for the more...
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June 18, 2020
One of the revelations of the COVID-19 pandemic is that the flexibility and potential of Bayesian designs goes far...
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June 18, 2020
A number of trials recently disrupted by the COVID-19 pandemic are now in the process of re-assessing recruitment...
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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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June 9, 2020
Trevor Mundel leads the Bill & Melinda Gates Foundation’s efforts to develop high-impact interventions against the...
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June 8, 2020
Cytel has recently published a new ebook on synthetic control arms, and a new scientific primer as well.
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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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May 12, 2020
In our previous blog, “Remote Working Arrangement – How to get it right?”, we talked about how the need for social...
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May 5, 2020
Cytel's team of oncology trial design and advanced analytics experts are hosting a series of complimentary webinars...
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April 29, 2020
In our previous blog, we spoke with Alind Gupta, who works as a Machine Learning Researcher at Cytel in Canada. The...
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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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April 23, 2020
Cytel is hosting a webinar, “A Clinician’s Perspective on Cancer Drugs Development”, on April 28, 2020. Our speaker,...
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April 23, 2020
Every Week Cytel Brings You Further Insights from the COVID-19 Trial Tracker From April 8 through April 17, the number...
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April 20, 2020
Cytel is hosting a webinar on Transparent Machine Learning in Oncology, on April 21, 2020. Our speaker, Alind Gupta,...
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April 7, 2020
Cytel has industry-leading experts in Statistical Programming with years of SAS® Programming expertise and in-depth...
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April 2, 2020
On March 16, the World Health Organization (WHO) Director-General, Dr. Tedros Adhanom Ghebreyesus, in his media...
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March 31, 2020
Since 1953, when the discovery of the structure of DNA was made, we have seen great advancements in genomics....
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March 26, 2020
Further regulatory guidance has been released concerning the implications of the Coronavirus disease (COVID-19) on...
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March 23, 2020
On March 20th the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA)...
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March 19, 2020
The FDA issued a guidance yesterday on how the COVID-19 Pandemic may affect the conduct of clinical trials. Below are...
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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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January 30, 2020
The Cytel Trial Design Innovations (CTDI) Webinar Series recently hosted a webinar on designing event-based studies....
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January 22, 2020
In the quest for clinical success, we all strive for evidence packages of the highest quality. If the clinical data is...
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January 16, 2020
January’s Cytel Trial Design Innovations (CTDI) Webinar Series will feature Biostatistician and pioneering Bayesian...
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January 8, 2020
In clinical development, data is the vital ‘foundation’ that supports your programs. To successfully bring a promising...
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December 16, 2019
Cytel Inc. and Axio Research joined forces in June 2019, expanding our ability to solve the most complex analytical...
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December 10, 2019
In association with Statisticians in the Pharmaceutical Industry (PSI) , UCB and Cytel hosted a symposium on September...
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December 5, 2019
Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel In...
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December 2, 2019
Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel...
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November 27, 2019
At the 2019 Challenges in Rare Diseases Clinical Trials Symposium and East training, Cytel partnered with Alexion to...
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November 21, 2019
Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel In my...
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November 14, 2019
Market access strategy is an integral part of the clinical development process to ensure success in global healthcare...
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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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October 10, 2019
A disease is generally considered to be rare if it affects one patient per 200,000 people (1) and most rare diseases...
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August 23, 2019
In place of collecting data from patients recruited for a trial who have been assigned to the control or...
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August 14, 2019
This article was originally published as part of a series by pharmaphorum in association with Cytel and is reproduced...
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August 7, 2019
In this blog, from our career perspectives series, we talk with Jayshree Garade Associate Director, Statistical...
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August 1, 2019
The term biomarker signature describes the behavior of a set of biomarkers that define a signature to maximize the...
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July 22, 2019
Health economics and adaptive design methods share common ground in that they both aim to support more efficient and...
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July 8, 2019
Cytel recently hosted a very well-attended and engaging webinar on the topic of “Estimands, not just a statistical...
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June 27, 2019
By Nicolas Rouillé and Eric Henniger The right design and the right data ultimately leads to the right decisions, so...
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June 14, 2019
This article was originally published as part of a series by pharmaphorum in association with Cytel and is reproduced...
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March 26, 2019
At the Partnerships in Clinical Trials Conference in Barcelona in November 2018, Strategic Consultant Ursula Garczarek...
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March 20, 2019
No one plans to have a trial whose data collection needs rescuing. However, lagging enrollment rates, operational...
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February 28, 2019
In honor of Rare Disease Day 2019 we share a new Cytel podcast featuring Cytel Strategic Consultant Ursula Garczarek...
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February 21, 2019
In 2018, Cytel ran a qualitative survey among biostatisticians and programmers on trends in data science and...
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February 8, 2019
A 2018 publication in the Biometrical Journal by Cytel’s Cyrus Mehta, Lingyun Liu and Sam Hsiao, ‘Optimal Promising...
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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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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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November 8, 2018
Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process...
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November 5, 2018
Cytel biostatisticians Cyrus Mehta and Lingyun Liu, together with Charles Theuer, CEO of TRACON Pharmaceuticals have...
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October 23, 2018
Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and...
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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 27, 2018
In this blog, we talk with Heiko Götte, Senior Expert Biostatistician at Merck about his upcoming presentation at...
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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 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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September 5, 2018
EnForeSys is Cytel’s tool for patient recruitment planning. We have discussed on the blog recently with Tufts...
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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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August 15, 2018
Cytel’s 7th East User Group Meeting (EUGM) will take place on November 14 & 15, 2018 at Merck in Darmstadt, Germany,...
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July 27, 2018
In this blog, we share a new infographic based on this popular blog post illustrating some of the critical interactions...
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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 18, 2018
A recent article published by Cytel authors Samadhan Ghubade, Sharayu Paranjpe, Kushagra Gupta, Anil Gore and colleague...
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July 16, 2018
In this blog we share a case study of how we established and ramped up a functional service outsourcing partnership for...
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July 3, 2018
It’s shaping up to be a busy year for Cytel’s software development team with a number of upgrades and planned launches...
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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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June 28, 2018
By Esha Senchaudhuri With thanks also to Jitendarreddy Seelam and Ramanatha Saralaya for their input. The fact of the...
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June 19, 2018
At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations...
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June 14, 2018
In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager...
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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 25, 2018
Data management is an essential building block for successful Immuno-Oncology (I-O) trials. At the Immuno-Oncology...
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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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April 13, 2018
We return to our discussion with Ken Getz of the Tufts CSDD for part 2 of our blog post on key challenges in clinical...
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April 5, 2018
Photo by J. Kelly Brito on Unsplash Research on clinical trial enrollment makes for sobering reading, characterized by...
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April 3, 2018
By Esha Senchaudhuri In response to its R&D productivity from 2005 – 2010, AstraZeneca took the initiative in 2011 to...
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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 28, 2018
There is a consensus in the industry that data on rare diseases is limited, incomplete, and difficult to find or...
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February 27, 2018
We extend our congratulations to Lipopharma and the CLINGLIO project consortium on their recent 6,15M€ grant award by...
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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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February 6, 2018
We were excited to learn recently that Ajay Sathe, the CEO of our India Operations, was awarded lifetime honorary...
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January 23, 2018
News Medical interviewed Dr. Rajat Mukherjee, Statistician, and Director of Data Science at Cytel to investigate the...
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January 9, 2018
Our Career Perspectives' series is back! Cytel has industry-leading experts in statistical programming with years of...
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November 28, 2017
In this blog we turn to some reading matter, and interview Gautier Paux and Alex Dmitrienko about the recent book...
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November 22, 2017
Cytel offers a full range of clinical data management services and the team of experts is spread across the globe. In...
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November 15, 2017
Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry...
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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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October 31, 2017
As part of Cytel's new Trial Innovations Webinar Series, Pat Mitchell, Statistical Science Director at AstraZeneca...
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October 27, 2017
In this blog, we share the second part of our interview with Bob Beckman, about a design concept for a confirmatory...
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October 18, 2017
Cytel's new Trial Innovations Webinar Series provides a platform for the most promising new statistical approaches...
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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 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 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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May 4, 2017
As a recognized expert in adaptive trials, Cytel has extensive experience designing and managing trials with interim...
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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 15, 2017
A precise and thorough approach to planning is key for success in data management. The Data Management Plan (DMP) is a...
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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 6, 2017
CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher...
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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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