The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
Career Perspectives: Interview with Tina Checchio, Associate Director, Quantitative Pharmacology & Pharmacometrics
QPP remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD, statistical modeling and the modeling of go-no-go decision rules. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those decisions right.
In this blog we talk to Tina who lives in Stonington, Connecticut, to find out more about her career path, current role at Cytel, and her interests outside of work.
PhUSE EU Connect 2018 took place in Germany’s financial capital Frankfurt, 4th - 7th November and brought together a range of experts to tackle the most pressing issues facing statistical programmers today. The agenda was superb with 143 presentations in 16 different streams and nearly 30 posters. This year’s event theme ‘Future Forward’ did not disappoint and there were some very thought-provoking talks on the drug development industry's challenges and what we can do in the future to meet these challenges. Additional hot topics were: Analytical Risk Based Monitoring, Machine Learning, and Data Standards and Governance. We found this year's event informative and well attended.
In this blog, we share the contributed posters and presentations from our Statistical Programmers and summarize some of the particular highlights from the sessions and posters that our team members attended.
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.
The "Master Recipe": Quality and Attention to Details Matter When Submitting CDISC Packages to Authorities
One of my wife’s favorite TV shows is ‘Quattro Ristoranti’ (Four Restaurants). In each episode of the show, 4 restaurants of the same style are assessed and the one getting the best evaluation wins the prize. One of the first things the TV presenter Alessandro Borghese, a famous Italian chef, does while visiting the restaurant is to assess (of course!) the kitchen and how much the kitchen and its tools are cleaned. This assessment could have a big impact on the final outcome regardless of the quality of the food served in the restaurant .... the state of the kitchen and its cleanliness influences Borghese’s faith in the chef’s work.
This is exactly what could happen in a data submission to health authorities such as the FDA: the efficacy and safety of your drug are of course what matter, but lack of traceability, or poor or insufficient documentation might trigger questions and concerns from the reviewer. While this might not impact the overall final outcome of your submission, approval could be delayed if the reviewer starts questioning what you have done by requesting changes, or new deliverables to clarify the aspects that were not sufficiently clear in your original submission.
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.
After having spent 15 years in the pharmaceutical industry, in May of 2018, I decided to explore new horizons and took the lead of the newly created Basel statistical programming team at Cytel. Building a new team in an exciting environment and being part of a successful story was the challenge I was looking for. In this blog, I will share my perspectives on what a sponsor programmer might expect when moving into a CRO role, and some of the differences and similarities of working within the two environments.