Podcast: Enhancing Patient Enrollment Forecasting with EnForeSys 2.0

Posted by Cytel

Sep 5, 2018 8:50:00 AM

 

EnForeSys is Cytel’s tool for patient recruitment planning. We have discussed on the blog recently with Tufts University's Center for the Study of Drug Development, Ken Getz, the problem the industry continues to face with patient recruitment, and the fact that most trials significantly exceed their original planned duration. In the face of this problem there's a pressing need to create more...

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Topics: patient enrollment, enforesys, clinical trials


Highlights from the JSM 2018 Conference

Posted by Cytel

Aug 31, 2018 11:32:00 AM

 

JSM 2018, ASA’s annual gathering of over 6500 attendees attracted statisticians and data scientists to the beautiful city of Vancouver on July 28 – August 2. The conference offers a one of a kind opportunity for statisticians to exchange ideas and explore opportunities for collaboration. In this blog, we will provide access to our team's slide decks from the event, as well as some of their...

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Topics: biostatistics, adaptive designs, data science, Bayesian, careers


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 Does a CRO Programming Career Stack Up?

Posted by Nassim Sleiman

Aug 21, 2018 8:18:00 AM

 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...

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Topics: Statistical Programming, clinical research, careers


2018 East User Group Meeting Addresses Multiplicity Themes, with keynotes including Stephen Senn and Meinhard Keiser.

Posted by Cytel

Aug 15, 2018 6:08:00 AM

 

Cytel’s 7th East User Group Meeting (EUGM) will take place on November 14 & 15, 2018 at Merck in Darmstadt, Germany, bringing together industry experts, thought leaders and applied statisticians to discuss the future of clinical trials.

The agenda has been developed collaboratively by the EUGM Scientific Committee, and keynote speakers will include Stephen Senn, Meinhard Kieser, Thomas...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East, adaptive designs, Bayesian Methods


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


Infographic: 5 Key Interactions of Data Management and Statistics

Posted by Cytel

Jul 27, 2018 7:53:00 AM

In this blog, we share a new infographic based on this popular blog post illustrating some of the critical interactions that need to take place between data management and statistics groups to help ensure efficiency and data quality. 

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Topics: big data, EDC, data manager, Clinical Data, database build, Clinical Research Services, Data Management, clinical trials, Statistical Analysis


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


Case Study:Creating an Effective Functional Services Partnership

Posted by Cytel

Jul 16, 2018 2:49:00 AM

In this blog we share a case study of how we established and ramped up a functional service outsourcing partnership for biostatistics, programming and data management.

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Topics: SAS, Statistical Programming, outsourcing


Unveiling New East 6.5 Modules: Join Our Webinar

Posted by Cytel

Jul 3, 2018 4:15:47 AM

 

 It’s shaping up to be a busy year for Cytel’s software development team with a number of upgrades and planned launches across our range of tools. (Watch this space for announcements soon on new quantitative decision-making software OK GO and an upgrade to EnForeSys). East, our industry leading platform for clinical trial design, simulation, and monitoring will be unveiling version 6.5 in...

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Topics: Adaptive Clinical Trials, Trial Design, phase 2, Program and Portfolio Optimization, Simulations, East


Highlights from the PSI 2018 Conference

Posted by Cytel

Jul 2, 2018 10:00:00 AM

A number of the Cytel team were in Amsterdam, 3rd- 6th June 2018 for the PSI Conference. This year’s conference was held at the magnificent Beurs Van Berlage, a venue full of history and interesting architectural features. We took the opportunity to give delegates a first look at OK GO, our new clinical trial Go/No-Go decision-making software in this magnificent setting.

In this blog, we'll...

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Topics: biostatistics, adaptive designs, PSI Conference, Clinical Data, Adaptive Clinical Trials, data science, estimands, Bayesian


Measuring lots of little details: Non-Compartmental Analysis and the Early Phase Regulatory Environment.

Posted by Cytel

Jun 28, 2018 6:53:00 AM

 

By Esha Senchaudhuri

With thanks also to Jitendarreddy Seelam and Ramanatha Saralaya for their input.

The fact of the matter is that I now want to recall everything, every trifle, every little detail. I still want to collect my thoughts and - I can't, and now there are these little details, these little details...” ― Fyodor Dostoyevsky, The Meek One

Old Fyodor was hardly talking about...

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Topics: clinical trials, Clinical Development Strategy, Early Phase Trials, pharmacology


The Importance of Standardization in Clinical Outsourcing

Posted by Cytel

Jun 19, 2018 9:30:00 AM

 

At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations at Amgen) presented to delegates the strategic choices open to sponsors when  choosing an outsourcing model and the three fundamental issues in play: standardization, flexibility and cost. In Dr. Otte's view, standardization of systems and processes is key, but is often...

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Topics: clinical trials, Clinical Research Services, Clinical Development Strategy, outsourcing


What makes a good data manager?

Posted by Cytel

Jun 14, 2018 10:30:00 AM

In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager role has evolved. 

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Topics: clinical data management, big data, Biometrics, clinical trials, real world evidence


Career Perspectives: Interview with Andrea Hita, Biomedical Data Scientist

Posted by Cytel

Jun 7, 2018 8:39:00 AM

Cytel data scientists apply advanced statistical techniques including predictive modelling of biological processes and drug interactions to unlock the potential of big data.

In this blog from our Career Perspectives series, we talk to Andrea Hita, at Data Scientist at Cytel, to find out more about her career path, her current role at Cytel and her interests outside of work.

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Topics: careers, clinical research, CRO, Recruitment, clinical trials, Trial Design, data science, adaptive designs, genetic algorithm, model-informed-drug-development, R language


5 Reasons to Integrate Model-Based Meta-Analyses (MBMA) Into Your Clinical Development Strategy

Posted by Cytel

May 31, 2018 3:48:00 PM

By Esha Senchaudhuri

An important trend in clinical development involves integrating strategic pharmacometric analysis with program level decision-making, to make the most use of available data. This can occur in various forms, from leveraging preclinical data for go-no-go decision making [1], to the need for improved comparative effectiveness frameworks [2].

Here we have five reasons why you...

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Topics: biostatistics, pharmacometrics, pharmacology, meta-analysis, quantitative decision-making


Addressing Critical Unmet Oncology Needs in the Era of Precision Medicine

Posted by Cytel

May 23, 2018 12:21:00 PM

 

 

Our Industry Voices series showcases our clients’ innovative work and breakthrough therapeutics in oncologic indications and other critical areas of medical unmet need.

In this article, we sit down with Charles Theuer, M.D., CEO of TRACON Pharmaceuticals to discusshis work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of...

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Topics: biostatistics, Oncology, Phase 1, Phase 3, Clinical Development Strategy, Adaptive Clinical Trials


Exploring Differences Between Pinnacle 21 Community and Enterprise versions for CDISC Compliance

Posted by Cytel

May 22, 2018 6:39:00 AM

 At the recent CDISC EU Interchange in Berlin,  Angelo Tinazzi, Director of Clinical Data Standards and Submissions at Cytel, showcased a popular poster presentation analyzing the differences between the Pinnacle 21 enterprise (P21e) and community versions. Those working in the field of data standards, will know that Pinnacle 21 is led by the team that created OpenCDISC, and is now the leader...

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Topics: CDISC, Statistical Programming


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