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


2017 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop

Posted by Cytel

Oct 24, 2017 6:01:00 AM

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...

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Topics: Clinical Data, Clinical Research Services, Adaptive Clinical Trials, adaptive designs, Sample Size, adaptive sample size re-estimation, Bayesian, Regulation, FDA, Promising Zone


When Biostatisticians Disagree About Ethics

Posted by Cytel

Jul 6, 2017 9:09:00 AM

 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 [1]; shorter trials for the most effective new therapies (see the early stopping outcome of the MUSEC trial) [2]; and enrollments commensurate with the needs of research, i.e. the last patient enrolled is not superfluous to a...

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Topics: biostatistics, Regulation, patient enrollment, Adaptive Clinical Trials, medical ethics


Under wraps: the importance of patient privacy

Posted by Manjusha Gode

Jun 28, 2017 4:36:40 AM

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...

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Topics: biostatistics, Statistical Programming, Clinical Research Services, CDISC, Regulation


Case Study: Redesigning a Pragmatic Trial in Oncology

Posted by Cytel

Apr 28, 2017 9:42:44 AM

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.

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Topics: biostatistics, real world evidence, Oncology, Regulation


Estimands 101: Interview with Mouna Akacha

Posted by Cytel

Feb 27, 2017 7:39:00 AM

 

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...

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Topics: biostatistics, clinical development, Regulation


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


CDISC submissions- are you up to speed?

Posted by Cytel

Dec 21, 2016 9:45:00 AM

 

December 18th 2016 was a significant date for the pharmaceutical industry and regulatory submissions. For trials which commence after this date, the FDA will no longer accept non-CDISC data submissions for new drug applications ( NDAs) , certain investigational new drug applications, abbreviated new drug applications (ANDAs)  and certain biologics license applications (BLAs).

 The FDA...

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Topics: Clinical Data, data manager, SDTM, CDISC, CDASH, Regulation


Operational and regulatory considerations in a promising zone trial

Posted by Cytel

Aug 9, 2016 9:00:00 AM

At the recent JSM Meeting, Cytel’s Yannis Jemiai presented the case study of the VALOR trial which used a promising zone design. At the time of the study, existing therapy for relapsed or refractory AML was generally unsatisfactory with no approved drugs available for patients, and a very poor prognosis.  Vosaroxin was a first-in-class anticancer quinolone derivative which had previously been...

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Topics: Clinical Research Services, Regulation, biostatistics, adaptive trials, adaptive designs, Oncology, ACES, DMC


Special Update: US House of Representatives Passes 21st Century Cures Act

Posted by Cytel

Jul 10, 2015 12:54:00 PM

Here at Cytel, we are engaging in a small celebration this afternoon, as the US House of Representatives has just passed the FDA Reform Bill more generally known as the 21st Century Cures Act.

Although this bill is widely viewed as a reform bill, it will provide extensive funding to both the FDA and NIH to ensure that clinical and pharmaceutical research lives up to its potential to deliver...

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Topics: Bayesian Methods, Regulation, Medical Devices, Adaptive Clinical Trials


Building Teams to Handle Unexpected Regulatory Agency Requests

Posted by Esha Senchaudhuri

Jun 5, 2015 11:00:00 AM

Not long ago, one of our clients submitted Phase 2 and Phase 3 data for a new rare disease drug which had received priority review status. Following submission, regulators requested that our client also submit pooled data from its Phase 1 studies along with a safety analysis. This analysis had the potential to clinch NDA approval for the new product.

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Topics: Data Management, Clinical Research Services, Regulation, Phase 1


How Proposed Regulatory Reforms Will Affect Your Clinical Trial

Posted by Esha Senchaudhuri

Feb 17, 2015 6:40:00 PM

21st Century Cures (also called Cures2015) is a bipartisan initiative undertaken by the Committee on Energy and Commerce of the US House of Representatives. Amongst the many factors motivating this landmark legislation is the concern  that regulatory procedures must keep up to date with innovations in clinical development. Cures2015 aims to reform the regulation of drugs, biologics and medical...

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Topics: Bayesian Methods, Regulation, Medical Devices, Adaptive Clinical Trials


Statisticians on Software Development Part II: The Philosophy Behind a Software Package

Posted by Esha Senchaudhuri

Sep 25, 2014 10:06:00 AM

 

East: Learn More  StatXact: Learn More Compass: Learn More

A few weeks ago, we posted a synopsis of an event held at ISCB Vienna in which statisticians from Cytel, SAS and Stata spoke about processes for developing software for statisticians. The button below will guide you to a copy of the presentation by...

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Topics: East 6.3, Cytel Consulting, Regulation, Statistical Programming, Entrepreneurship


Overcoming Prowell's Pitfalls: Cytel Weighs in on Strategies for Oncology Development

Posted by Esha Senchaudhuri

Jun 10, 2014 7:01:00 AM

 East: Learn More

The FDA’s Tatiana Prowell (Breast Cancer Scientific Lead in the Office of Hematology  & Oncology Products) recently gave an interview to the Nature Review Drug Discovery, in which she discusses the top three pitfalls faced by drug developers in oncology. Issues which Prowell cite include: selection of appropriate dosage, trial designs without...

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Topics: Oncology, East, Regulation, FDA, East PREDICT, Predictive Enrichment, Interim Analyses, Prediction


New JAMA Study Confirms Importance of Trial Design for FDA Approval

Posted by Cytel Consulting

Apr 24, 2014 11:00:00 AM

Here at Cytel we firmly believe that if you don’t get the design of a clinical program right, then nothing else matters. A study recently published by the Journal of the American Medical Association, once again confirms the vital importance of proper trial design for the timely approval of a new drug. The article reports that nearly half of all submitted NME applications fail upon first...

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Topics: Cytel Consulting, Trial Design, Efficacy, Regulation, Safety


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