Nand Kishore Rawat is a Director and Head, Early Phase Biostatistics based in the King of Prussia, PA Cytel office. We recently spoke with Nand for the Cytel podcast to gain his thoughts on the unique aspects of Phase 1 development and where innovative approaches supported by thorough planning can meet these challenges head-on.  Read on for key insights or listen to the podcast. 

Topics: clinical research, clinical trials, biostatistics, Cytel Strategic Consulting, clinical development, Phase I, pharmacometrics, quantitative decision-making

 

In this blog, Paul Terrill, Director of Strategic Consulting at Cytel outlines his blueprint for ensuring smooth communication between statistical and clinical stakeholders. Paul draws upon his 20 years of experience working as a statistician and his training background to share his guidelines for success. Whether you are a statistician looking to hone your project communication skills, or a...

Topics: clinical research, clinical trials, SDTM, biostatistics, Cytel Strategic Consulting, clinical development

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.

Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, adaptive designs, Adaptive Clinical Trials, clinical trials, Regulation, big data, Trial Design Software, Software Simulations, genetic algorithm

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.

Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, adaptive designs, Adaptive Clinical Trials, clinical trials, Regulation

Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, adaptive designs, Adaptive Clinical Trials, clinical trials, Regulation, Trial Quality

We have written on the blog in the past about the value that a statistical consultant can bring to your team, and to the overall clinical development process. Statistical consultants can be instrumental to the success of your development program, providing a variety of input from creating innovative trial designs that improve information quality and efficiency, to supporting regulatory...

Topics: Cytel Strategic Consulting, pharmacometrics, quantitative decision-making, model-informed-drug-development

By Gordhan Bagri and Munshi Imran Hossain with  H A S Shri Kishore

Shiny (from RStudio) is one of the most popular R packages. The package allows programmers to create applications with interactive user interfaces. These applications can then be deployed for non-programmers to perform analysis. Non-programmers can, therefore, make use of the statistical capabilities of R by means of point and...

Topics: data science, Statistical Analysis, Cytel Strategic Consulting, R language, R programming

At Cytel our strategic consulting team works on a wide range of projects including: Identifying the best clinical trial design, implementing adaptive designs, developing a regulatory strategy and interacting with regulators.

In this blog we talk to Sam who lives in the Boston area, to find out more about his career path, current role at Cytel, industry experience and his interests outside of...

Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, adaptive designs, Adaptive Clinical Trials, clinical trials

A recent article published by Cytel authors Samadhan Ghubade, Sharayu Paranjpe, Kushagra Gupta, Anil Gore and colleague Krishna Asvalayan in the journal Current Science, tackles the topic of adverse drug reactions (ADRs) – a matter of great concern in drug research. The authors focused their research on drugs which had been either banned or withdrawn due to a serious problem of ADRs and...

Topics: data science, signal detection, pharmacovigilance, Statistical Analysis, Cytel Strategic Consulting

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 Benjamin who lives in France, to find out more about his career path, achievements, current role at Cytel and his interests outside of work. 

Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, clinical development, clinical trials, adaptive trials, adaptive designs

Our strategic consulting team work on projects such as: Identifying the best clinical trial design, implementing adaptive designs, developing a regulatory strategy and interacting with regulators.

In this blog we talk to Ursula who is based in Germany, to find out more about her career path, achievements, current role at Cytel and her interests outside of work. 

Topics: Statistical Analysis, careers, clinical research, Statistical Programming, CRO, Recruitment, Cytel Strategic Consulting, biostatistics, adaptive designs, Adaptive Clinical Trials, clinical trials

As we prepare to close the door on 2017, we thought we would take a look back at the  topics which have been most popular on the Cytel blog this year.  It's an interesting insight on what pain points and opportunities feature highly on our global biopharma audience's radar.  Read on to learn which of our 2017 blogs have received the most interest from our audience so far.

Topics: Statistical Analysis, R language, data science, Trial Design Software, Cytel Strategic Consulting, Data Management, pharmacometrics, NONMEM, estimands, Oncology

In 2011, Cytel organized its first East User Group Meeting (EUGM) in Paris. Since then, we have held an EUGM almost every year, alternating between locations in Europe and North America.  These meetings have been a great success, giving opportunities for customers and industry colleagues to meet each other as well as with key opinion leaders, whilst learning more about our East software and...

Topics: EAST 6.4, Adaptive Clinical Trials, adaptive trials, Statistical Innovations in Clinical Development, Clinical Development Strategy, Cytel Strategic Consulting

James (Jim) Bolognese, Senior Director, Strategic Consulting, Clinical Services at Cytel Inc. was named a 2017 fellow of the American Statistical Association (ASA). Jim will be officially honored by the ASA at the Joint Statistical Meetings in Baltimore, Maryland this summer.

Topics: biostatistics, Adaptive Clinical Trials, adaptive designs, Interim Analyses, Cytel Strategic Consulting, Statistical Analysis, Clinical Development Strategy

Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies.  They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD)  characteristics, and of course identify the maximum tolerated dose (MTD).

Conventionally, SAD  and MAD studies were conducted separately, but increasingly are combined...

Topics: biostatistics, adaptive trials, adaptive designs, Cytel Strategic Consulting, Cytel Consulting, Statistical Programming, Compass, Dose-Finding, Phase 1, Phase I

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.

Topics: biostatistics, adaptive trials, adaptive designs, Regulation, Cytel Strategic Consulting, Cytel Consulting

 

In the complex world of trial design and data analysis biostatisticians and data scientists need to ensure they are selecting and harnessing the best capabilities of the powerful software tools available to them. Particularly when non-standard approaches are required, this may mean using a combination of tools to come to the most appropriate solution for any task.

At the recent EARL...

Topics: Cytel Strategic Consulting, R, Rstats

At a recent Pfizer/ Cytel seminar on rare disease and oncology development, Cytel’s Lingyun Liu presented innovative work on a patient enrichment design. In this blog, we share some design and operational considerations. This approach can help mitigate against underpowering of a clinical trial where there is uncertainty and heterogeneity of treatment effect among subpopulations.

Topics: biostatistics, Cytel Strategic Consulting, Enrichment, patient enrollment, adaptive trials, Oncology, Phase 3, personalized medicine

 

Challenge

Our client had the following key questions which they wanted our pharmacometrics group to address for an upcoming phase 2 trial of their ulcerative colitis compound .

1) Can knowledge from pre-clinical and Phase 1 data inform on the optimal range of doses for an upcoming Phase 2 dose-ranging study?

2) How may the dose response observed in PD markers in Phase 1 healthy volunteers...

Topics: biostatistics, Cytel Strategic Consulting, pharmacometrics, PK/PD, Case Study

 

Exposure-response data gained from clinical studies can provide a basis for model-based analysis and simulation, helping to predict the expected relationships between exposure and response.  Using this approach, it may be possible to optimize dosage regimens and to individualize treatment in specific patient subsets for which there are limited data.  In this blog, we examine a case study of...

Topics: biostatistics, Phase 3, Cytel Strategic Consulting, pharmacology, pharmacometrics, PK/PD