Career Perspectives: Interview with Munshi Imran Hossain, Senior Data Scientist

Posted by Cytel

Oct 23, 2018 11:00:00 AM

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.

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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


Career Perspectives: Interview with Adam Hamm, Director of Biostatistics

Posted by Cytel

Sep 20, 2018 1:04:00 PM

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.

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


Career Perspectives: Interview with Meredith Alm, Manager, QA Compliance

Posted by Cytel

Aug 23, 2018 9:11:00 AM

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,...

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


How can a strategic pharmacometrics consultant add value to your team?

Posted by Cecilia Fosser

Aug 8, 2018 9:45:00 AM

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...

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


Building interactive web applications using R Shiny

Posted by Gordhan Bagri

Aug 1, 2018 5:34:00 AM

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...

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


Career Perspectives: Interview with Sam Hsiao, Associate Director, Strategic Consulting

Posted by Cytel

Jul 24, 2018 6:29:00 AM

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...

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


Recent Publication: On shapes of ADR report accumulation data

Posted by Cytel

Jul 18, 2018 4:40:00 AM

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...

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


Career Perspectives: Interview with Benjamin Esterni, Principal Biostatistician

Posted by Cytel

Mar 16, 2018 7:00:00 AM

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. 

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


Career Perspectives: Interview with Ursula Garczarek, Associate Director - Strategic Consulting

Posted by Cytel

Feb 13, 2018 9:00:00 AM

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. 

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


Round-Up:The 6 Hottest Blog Topics from 2017

Posted by Cytel

Dec 21, 2017 6:44:00 AM

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.

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


Slides: East User Group Meeting and Trial Design Symposium

Posted by Cytel

Dec 4, 2017 11:28:00 AM

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...

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


Jim Bolognese named 2017 American Statistical Association Fellow

Posted by Cytel

May 22, 2017 9:00:00 AM

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.

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


Accelerating development with combined SAD/MAD approach

Posted by Cytel

Jan 30, 2017 9:50:24 AM

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...

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


How to get the regulatory green light for your adaptive design?

Posted by Cytel

Jan 23, 2017 10:35:00 AM

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.

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


Harnessing the power of R API to extend software applications

Posted by Aniruddha Deshmukh

Dec 13, 2016 8:18:00 AM

 

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...

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Topics: Cytel Strategic Consulting, R, Rstats


Innovative Phase 3 Adaptive Enrichment Design in Oncology

Posted by Cytel

Dec 2, 2016 9:19:10 AM

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.

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


Case Study: Dose-response modeling informs Phase 2 ulcerative colitis study design

Posted by Cytel

Nov 18, 2016 10:04:00 AM

 

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...

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


Case Study:Exposure Response Modeling in Hematology

Posted by Cytel

Sep 13, 2016 10:15:00 AM

 

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...

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


Case Study:Seamless Phase 2/3 Design in Rare Disease

Posted by Cytel

Sep 9, 2016 9:24:00 AM

 

Challenge:

Our client, an emerging biotechnology company, was preparing for the next stage of development for their novel compound in a rare disease.  They had two major concerns which they wanted the clinical trial design to address- an anticipated difficulty in recruiting subjects to the trial, and  the cost and time investment associated with running separate phase 2 and phase 3 trials. ...

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Topics: biostatistics, adaptive trials, EAST 6.4, Seamless designs, phase 2, Phase 3, Clinical Research Services, Cytel Strategic Consulting


How to Shorten a Cardiovascular Outcome Trial By Two Years

Posted by Esha Senchaudhuri

Feb 10, 2015 5:28:00 PM

Cardiovascular outcome trials (CVOTs) have earned the reputation of being the untamable behemoths of the clinical world. Needless to say these trials are long and require extremely large sample-sizes. The Contrave LIGHT study required 8900 patients. The SAVOR TIMI trial enrolled 16,492 patients. Even the EXAMINE trial, which benefited from a promising zone design, required 650 patients. 

However,...

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Topics: Cyrus Mehta, Promising Zone, Cytel Strategic Consulting, Interim Analyses, Program and Portfolio Optimization, Cardiovascular, Clinical Development Strategy


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