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

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

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...

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

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

There is a consensus in the industry that data on rare diseases is limited, incomplete, and difficult to find or access. Recently we came across the CoRDS patient registry based at Sanford University and learned that the registry is an effective tool used to gather information useful to researchers studying rare diseases.

We sat down with Benjamin Forred, Project Manager, and Austin Letcher,...

Topics: Rare Disease, CRO, clinical research, Adaptive Clinical Trials, Clinical Data, real world evidence

Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry executives to discuss pressing challenges in a collaborative environment. This year, our Senior V.P. of Clinical Research Services, Irving Dark, discussed the topic of vendor qualification and posed the question to the group: are there better alternatives to the traditional...

Topics: Clinical Research Services, Clinical Data, CRO, outsourcing

 

Last month was the eighth American Conference on Pharmacometrics (ACoP8) in Florida, a key event on the calendar for Cytel’s Quantitative Pharmacology and Pharmacometrics subject matter experts.

Cytel was delighted to contribute to the event this year and present two posters. This was excellent opportunity to share our knowledge and innovative research, alongside networking with likeminded...

Topics: Clinical Data, pharmacometrics, pharmacology, Clinical Research Services, model-informed-drug-development, clinical development, Phase 1

In this blog, we share the second part of our interview with Bob Beckman, about a design concept for a confirmatory basket trial. Beckman is Professor of Oncology and of Biostatistics, Bioinformatics, and Biomathematics at Lombardi Comprehensive Cancer Center and the Innovation Center of Biomedical Informatics, Georgetown University Medical Center. The first part of the interview, which...

Topics: Clinical Data, adaptive designs, FDA, basket trials, Oncology

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...

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

The Society for Clinical Data Management (SCDM) conference landed in Orlando last week providing insights and key trends for clinical data managers from around the world.  In this blog we share an infographic of some of the agenda highlights along with a more detailed overview of our Alla Muchnik's contribution to the session Study Medication Compliance: Data Collection Challenges. 

Topics: Interim Analyses, Clinical Data, Data Management, Clinical Research Services

As a  biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and helping to minimize the oversight burden for the sponsor. In this case study, we describe our work with a client on two Phase 1 studies, and how we were able to carry a number of important efficiencies from the first study to the second.  

Topics: biostatistics, Phase 1, outsourcing, Clinical Research Services, Statistical Programming, medical writing, clinical data management, Clinical Data

The Adaptive Designs and Multiple Testing Procedures Workshop (ADMTP), the first joint meeting of the Adaptive Designs Working Group of the MRC Hubs for Trials Methodology Research and the joint ADMTP Working Group of the International Biometrics Society German and Austro-Swiss Regions, took place in Cambridge, UK last month. 

Topics: biostatistics, adaptive designs, Clinical Data, Adaptive Clinical Trials

A number of the Cytel team were in London, 14th – 17th May 2017 for the PSI Annual conference. The PSI Conference is an important forum for statisticians and we found this year's event insightful, informative and well attended. In this blog, we'll summarize some of the particular highlights from the sessions that our team members attended.

Topics: biostatistics, adaptive designs, PSI Conference, Clinical Data, Adaptive Clinical Trials

 

A precise and thorough approach to planning is key for success in data management.

The Data Management Plan (DMP) is a critical document in any data management project. It outlines all of the data management work to be done, the timelines and milestones to be achieved, as well as the outputs to be produced. The DMP lets all of the stakeholders know what to expect, how to expect it and when...

Topics: Clinical Data, Data Management, data manager, outsourcing, Clinical Research Services

Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may  have different priorities and processes when working with external vendors to larger pharmaceutical organizations.

Topics: Clinical Data, data manager, outsourcing, Biometrics, biostatistics, RFP

 

CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher quality medical research’.  The organization delivers this mission through the development of data standards designed to streamline clinical research- these standard formats are increasingly expected for use in data submissions by regulatory authorities. Importantly, data...

Topics: Clinical Data, Biometrics, Statistical Programming, CDISC, CDASH, SDTM, ADaM, Training and Education

 

As we prepare to say 'so long, farewell'  to 2016, we'd like to take the opportunity to thank all our blog readers and subscribers.  Read on for a  round up of our most read topics from the year.... 

Topics: Clinical Data, data manager, EDC, database build, adaptive trials, adaptive designs, SDTM, CDISC

 

December 18^th 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...

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

 

Data Standards play a crucial role in structuring and promoting long term value of clinical data.

Clinical Data Acquisitions Standards Harmonization or CDASH was developed with participation from all three ICH regions (US, Europe and Japan) with recommended data collection fields for 16 domains-> DEMOG, AE etc. It also includes  implementation guidelines, best practice recommendations, and...

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

The management of quality clinical data collection is built on a number of core essentials- including project management, timeline management, understanding of the deliverables, alignment with statistics and selection of the right technologies.  However, clinical development is a complex business and clinical data management approaches must be tailored to meet the specific needs of the trial. ...

Topics: Clinical Data, data manager, EDC, database build