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 overlooked as a factor by companies of all sizes when deciding how to outsource clinical trial activities. In this blog, Dr Otte joins us to share his insights on this topic, as well as this views on how outsourcing has evolved in recent years, and the future trends that will have most impact. 

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


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


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


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 should consider utilizing model-based meta-analyses ( MBMAs)  for your program or portfolio development.

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Topics: pharmacometrics, biostatistics, 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 discuss
his work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of efficient trial design in rare cancers. Click here to download a .pdf of the article, or read on. 

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


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 in software and services for managing CDISC compliance and clinical data quality.  The organization continues to offer a community based software tool, in line with the OpenCDISC model, but now offers an enterprise version to sponsors and CROs, that is also used by the FDA itself. 

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Topics: Statistical Programming, CDISC


Rewriting the oncology textbook with cell-based immunotherapies

Posted by Cytel

May 16, 2018 11:00:00 AM

 

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 are delighted to share an interview with Kurt Gunter, M.D., Chief Medical Officer of Cell Medica in which he discusses his work, his views on the key advancements in oncology development, the unmet needs yet to be overcome, and the importance of strategic biostatistics input to his organization. Read on, or click here to download a copy of the article to read offline.

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


Innovative Oncology Trial Designs in Practice

Posted by Cytel

May 9, 2018 10:22:00 AM

As we prepare to head to ASCO in under a month's time, we are pleased to share a new ebook that showcases some key applications of innovative trial designs in the oncology development space.

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


Breaking Boundaries in Drug Development at PSI

Posted by Cytel

May 2, 2018 5:07:00 AM


PSI is a global member organization dedicated to leading and promoting best practice and industry initiatives for statisticians in the biopharmaceutical industry. The PSI annual conference is going from strength to strength, attracting increasing numbers of delegates from Europe and beyond. With the 2018 conference taking place in Amsterdam in only a month’s time, we took the opportunity to sit down with Lucy Rowell, Senior Principal Statistical Scientist at Roche and the Conference Chair, to learn more about this year’s venue, themes, and new hot topics, along with insights on Lucy’s vision for the future of the PSI organization. We look forward to seeing you in The Netherlands! 


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Topics: biostatistics, data science, quantitative decision-making


Career Perspectives: Interview with Omar Sefiani, Principal Statistical Programmer

Posted by Cytel

Apr 28, 2018 9:50:00 AM

Cytel has industry-leading experts in Statistical Programming, our programmers have years of SAS® Programming expertise, combined with in-depth knowledge of the specific clinical subject matter, which allows for competent and on-time completion of tasks.

In this blog, we talk to Omar, who is based in Geneva to find out more about his career path, current role at Cytel and his interests outside of work.

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Topics: Recruitment, Trial Design, Statistical Programming, Statistical Analysis, Phase 3, CDISC, careers, clinical trials, CRO, clinical research


Infographic: Overcoming Data Management Challenges in Immuno-Oncology Trials

Posted by Cytel

Apr 25, 2018 10:13:00 AM

Data management is an essential building block for successful Immuno-Oncology (I-O) trials. At the Immuno-Oncology Clinical Trials operations meeting in New York in earlier this year,  Patti Arsenault, VP Quality Assurance at Cytel discussed with Christopher Lamplugh, AVP, Clinical Data Management, Global Data Operations at Merck, the key challenges for data management in the space, and what’s needed to overcome them. 

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


Developing the Next Generation of Skills for Statistical Programmers

Posted by Cytel

Apr 18, 2018 6:09:00 AM

Our recent Clinical Biometrics Survey explored the views of respondents from across the statistical programming, biostatistics, and data management functions to learn their top challenges, and most important perceived industry trends and skills development. In this blog, our Ajay Sathe gives his perspectives on the key areas of personal and knowledge development that he believes statistical programmers need to focus on to keep abreast of the evolving drug development landscape. 

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Topics: Statistical Programming, biostatistics, SAS, clinical data management, R language


Interview with Ken Getz: Exploring Challenges of Clinical Trial Operations Part 2

Posted by Cytel

Apr 13, 2018 7:21:00 AM

We return to our discussion with Ken Getz of the Tufts CSDD for part 2 of our blog post on  key challenges in clinical trial operations. You can find Part 1 of the interview here, or read on to gain his insights on the fundamental problem at the heart of clinical trial operations challenges, and his views on the initiatives and programs that he believes show the most promise for the future. 

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Topics: forecasting, patient enrollment, enforesys, clinical trials


Interview with Ken Getz: Exploring Challenges of Clinical Trial Operations Part 1

Posted by Cytel

Apr 5, 2018 8:30:00 AM

Photo by J. Kelly Brito on Unsplash

Research on clinical trial enrollment makes for sobering reading, characterized by the oft-cited statistic that 11% of active sites fail to enroll a single patient. In this first part of a two part interview, we sit down for a discussion with Ken Getz of the Tufts CSDD. Here, Mr. Getz expands on some of the Center’s more recent research on challenges in clinical trial operations. In the second part, to be published  next week, Mr. Getz will reveal his insights on the key opportunities for the future. 

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Topics: forecasting, patient enrollment, enforesys, clinical trials


Maximizing Preclinical Knowledge for Optimal R&D

Posted by Cytel

Apr 3, 2018 2:00:00 PM

 

By Esha Senchaudhuri

In response to its R&D productivity from 2005 – 2010, AstraZeneca took the initiative in 2011 to implement what it has called the 5R Framework to strengthen its capabilities. In a Perspectives article from Nature Reviews Drug Discovery [1], Paul Morgan and his team provided complex details about the success of this framework from the perspective of every stage of drug development. Between 2005 and 2010, AstraZeneca was behind industry averages in every phase of clinical development except Phase 1.  After the implementation of 5R, AstraZeneca success rates improved substantially. Indeed, it was announced by IDEA Pharma in March 2018 that AstraZeneca had topped its 2018 innovation index.  Here we examine to what Morgan et al, attribute AstraZeneca’s  success.  

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Topics: Program and Portfolio Optimization, clinical development, quantitative decision-making


Clinical Biometrics Survey Reveals Industry Challenges and Trends

Posted by Cytel

Mar 29, 2018 8:44:00 AM

 

To mark the occasion of our 30th anniversary, in late 2017 we conducted a brief survey to gain a snapshot of what professionals in data management, statistical programming, and biostatistics feel are the key challenges facing their functions, the top areas for skills development, and the clinical data areas they believe are likely to have the greatest impact on drug development.

We are now able to share our findings- read on for some highlights, and to download your complimentary copy of the report.

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Topics: Statistical Programming, biostatistics, SAS, Biometrics, clinical data management


A Year in the Life of a Software Trainer

Posted by Cytel

Mar 27, 2018 11:20:00 AM

 East is the industry standard platform for clinical trial design, simulation, and monitoring, improving scientific productivity during the critical planning stages of clinical development.  In this blog, our Hrishikesh Kulkarni takes us on a tour of his life as a Cytel software trainer and answers some frequently asked questions about how East training sessions work in practice.

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Topics: East ESCALATE, Trial Design Software, Multi-Arm Multi-Stage Studies, EAST 6.4


Case Study: CliPLab Develops and Implements a Clinical SAS Intensive Training

Posted by Cytel

Mar 20, 2018 8:06:00 AM

 

Photo by Nghia Le on Unsplash

CliPLab (Clinical Professional Laboratory) is Cytel’s premier training initiative for bridging the skills gap in biometrics and analytics within clinical development. Leveraging Cytel’s experience and reputation in biostatistics and clinical biometrics, the organization provides practical learning modules in clinical SAS programming, biostatistics, data management, pharmacovigilance, scientific medical writing, key therapeutic areas and crucial soft skills. With learning programs led by experienced trainers, CliPLab engages both with individual students, and companies (e.g. biopharma, CROs) needing to support and augment their internal training programs.

In this blog we share a case study of how CliPLab supported a pharmaceutical customer with a tailored SAS training program for a cohort of new graduate recruits. 

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Topics: Statistical Programming, SAS


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


What makes a Successful FSP Partnership Tick?

Posted by Natalie Fforde

Mar 14, 2018 11:31:00 AM

Photo by Agê Barros on Unsplash

by Natalie Fforde, Senior Director of FSP Services at Cytel


With effective use of outsourcing, sponsors are able to respond to market needs and change course where necessary, while ensuring a pool of highly qualified personnel are available to work on clinical trial projects. At Cytel we work with our clients to tailor the outsourcing model that works best for an organization's particular circumstances.
In this blog, I will take a look the Functional Service Provider ( FSP) outsourcing model and some of the key factors that can help make a partnership ‘tick’ successfully.

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Topics: Clinical Research Services, Statistical Programming, clinical data management


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