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...

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

 

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...

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

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...

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

 

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...

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

 

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

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.

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

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...

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

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.

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

 

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...

Topics: patient enrollment, enforesys, clinical trials

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

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. 

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

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...

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

 

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...

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

 

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...

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

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

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

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.

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

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...

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

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...

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

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. 

Topics: enforesys, forecasting, patient enrollment, clinical trials

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...

Topics: enforesys, forecasting, patient enrollment, clinical trials