Creating a Common Language: Forging Statistical and Clinical Collaborations

Posted by Paul Terrill

Dec 5, 2018 7:37:00 AM

 

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...

Read More

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


The Good Data Submission Doctor: 5 Top ADaM Frequently Asked Questions

Posted by Angelo Tinazzi

Nov 27, 2018 3:47:00 AM

 

This is the third in our blog series ' The Good Data Submission Doctor' in which Angelo Tinazzi, Director of Standards, Systems and CDISC Consulting at Cytel tackles key issues in preparing data for CDISC submission. In the previous “Good Data Submission Doctor” blog Angelo discussed his top 5 SDTM FAQ; in this article he turns his attention to the top FAQs for  ADaM. Read on for Angelo's...

Read More

Topics: clinical research, clinical trials, SDTM, ADaM, CDISC


New publication addresses critical issues in ultra-orphan indications

Posted by Cytel

Nov 5, 2018 7:01:00 AM

Cytel biostatisticians Cyrus Mehta and Lingyun Liu, together with Charles Theuer, CEO of TRACON Pharmaceuticals have recently co-authored a publication in the journal Annals of Oncology: “ An Adaptive Population Enrichment Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients with Advanced Angiosarcoma (TAPPAS Trial)”. The paper explores the features of this innovative...

Read More

Topics: clinical research, clinical trials, Oncology, Precision Medicine, adaptive trials, adaptive designs, adaptive sample size re-estimation, population enrichment


The Good Data Submission Doctor: 5 Top SDTM Frequently Asked Questions

Posted by Angelo Tinazzi

Nov 1, 2018 7:35:00 AM

 

In this second post of the “Good Data Submission Doctor” ( read my first post The Master Recipe: Quality and Attention to Detail Matter here) I would like to go through some of my favorite SDTM Frequently Asked Questions. These are questions I regularly receive in my capacity as a CDISC Subject Matter Expert, either from my colleagues or from the sponsor. Let’s start by taking a look at five...

Read More

Topics: clinical research, clinical trials, SDTM, ADaM, CDISC


Incorporating patient preferences and values into risk-benefit calculations opens new horizons

Posted by Cytel

Oct 26, 2018 8:59:00 AM

 

Read More

Topics: clinical research, clinical trials, clinical development, biostatistics, patientricity


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.

Read More

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


Highlights from the SCDM 2018 Conference

Posted by Cytel

Oct 16, 2018 11:00:00 AM

The Society for Clinical Data Management (SCDM) conference brought clinical data managers from around the world to Seattle-Bellevue, WA on September 23-26. The conference offered an unmatched opportunity to discover innovative solutions in the clinical data management industry. In this blog, we will share our data management colleagues' experiences, observed trends and contributions to the...

Read More

Topics: clinical data management, data manager, Clinical Data, clinical research, clinical trials, clinical development, CDM


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.

Read More

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


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...

Read More

Topics: patient enrollment, enforesys, clinical trials


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,...

Read More

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


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. 

Read More

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...

Read More

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


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...

Read More

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...

Read More

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. 

Read More

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.

Read More

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


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...

Read More

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


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...

Read More

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


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. 

Read More

Topics: enforesys, forecasting, patient enrollment, 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...

Read More

Topics: enforesys, forecasting, patient enrollment, clinical trials


The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.  Sign up for updates direct to your inbox. You can unsubscribe at any time.

 

Posts by Topic

see all

Recent Posts