The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and drug interactions to unlock the potential of big data.
In this blog we talk to Munshi Imran, who is based in Pune, India to find out more about his career path, current role at Cytel and his interests outside of work.
At Cytel we believe that expert statistical input has the power to shape the future of clinical development: de-risking portfolios, accelerating timelines, and increasing the probability of success.
In this blog we talk to Adam who lives in North Carolina United States to find out more about his career path, achievements, current role at Cytel and his interests outside of work.
Cytel has grown significantly over the last 30 years, with operations across North America, Europe, and India. All of our processes, talent, and expertise are applied to maximizing the value of clinical data. At Cytel, quality comes first, and our QA team are committed to ensuring processes are in place to support our services.
In this blog we talk to Meredith who lives in Somerville, Massachusetts, to find out more about her career path, current role at Cytel, and her interests outside of work.
The ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop is sponsored by the ASA Biopharmaceutical Section in cooperation with the FDA Statistical Association. Each year 800 statistical practitioners come together to absorb new information on statistical practices in all areas regulated by the FDA.
Cytel was honored to be involved in the workshop program, and our subject matter experts added value to the conference by sharing their academic and regulatory experiences.
Don’t worry if you missed the event!
In this blog, we share the full slide set slide from Cytel contributions at the ASA Biopharmaceutical Section Regulatory Industry Statistics Workshop.
By Esha Senchaudhuri
The ethical benefits of adaptive clinical trials have been widely acclaimed: higher prospects for patients to be enrolled into the correct trial arm ; shorter trials for the most effective new therapies (see the early stopping outcome of the MUSEC trial) ; and enrollments commensurate with the needs of research, i.e. the last patient enrolled is not superfluous to a trial’s outcomes (e.g. according to one clinical biostatistician, “trial designs that learn more and treat better with less burden and sacrificing of patients”) .
However, the acknowledgement that ethical benefits exist is a separate question from the degree to which they exist when compared to a more traditional design.
About the Author: Manjusha Gode has over 28 years' IT experience spanning delivery Management, quality management, software testing, people management, process improvement and multi-locational operations. She is a pioneering member of Cytel's clinical programming team.
Clinical data transparency improves decisions for all healthcare stakeholders including patients, caregivers, healthcare providers, payers, and regulators.
The topic of transparency and the process by which clinical trial data can be effectively anonymized and disclosed for use by researchers has become a hot topic in recent years. In this blog, we will discuss the broader context of patient privacy and the key considerations for biopharmaceutical companies in this area.
In this blog we share a case study in which our statistical consulting team helped a client redesign an oncology pragmatic trial to address regulatory agency questions.
It’s been hard to miss the prevalence of estimand-related discussions in the last year. This is a topic which is very much at the forefront of statistics discussions right now. We are lucky enough to welcome Mouna Akacha to the blog to give us the lowdown on estimands and the problems and opportunities they represent for the global biopharma industry.
Mouna is a Consultant in the Statistical Methodology Group of Novartis Pharma AG, based in Basel, Switzerland. She has a wide range of research interests including topics on missing data, longitudinal data and recurrent event data and is an active participant in the current estimand discussions.
Read on to find out everything you ever wanted to know about estimands but were afraid to ask…..
As a group, Cytel had over 40 successful regulatory interactions last year, many of which supported approvals for innovative trial design approaches. In this blog we look at some of the key success factors for regulatory interactions regarding adaptive designs.