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.
Jul 27, 2018 7:53:00 AM
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 summarize some of the particular highlights from the sessions that our team members attended.
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.
Feb 28, 2018 9:02:00 AM
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, Senior Research Associate at CoRDS to learn more about the registry and hopes for the future.
Nov 15, 2017 8:46:00 AM
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 qualification audit process? In this blog, we present Irving’s proposal for an innovative approach that could improve efficiency and allow sponsors to invest more time evaluating the operational and cultural aspects that have greater potential to ensure the success of a partnership
Nov 2, 2017 9:05:00 AM
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 industry professionals.
Oct 27, 2017 9:53:00 AM
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 focuses on the context of the design is available to read here. Otherwise, read on to learn more details about this innovative design which has the potential to drastically increase drug development efficiency. Beckman presented on this topic at Cytel's East User Group Meeting in October.
Oct 24, 2017 6:01:00 AM
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 matter experts added value to the conference by sharing their academic and regulatory experiences.
Don’t worry if you missed the event!
In this blog, we share the full slide set slide from Cytel contributions at the ASA Biopharmaceutical Section Regulatory Industry Statistics Workshop.
Oct 4, 2017 7:34:36 AM
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.
Aug 2, 2017 7:07:00 AM
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.
Jul 11, 2017 6:57:00 AM
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.
Jun 1, 2017 8:06:00 AM
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.
Mar 15, 2017 8:51:00 AM
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 to expect it.
The Society for Clinical Data Management (SCDM)‘s publication, Good Clinical Data Management Practices (GCDMP) (1), provides a complete chapter on Data Management Plans. (The GCDMP is available, even to non-members of the society, at their webpage). It is important to note that while DMPs are not regulated documents, they are in fact so commonly used across the industry they have become auditable, and therefore scrupulously close attention needs to paid to getting them right.
We outline 4 key points to bear in mind when creating or reviewing a Data Management plan.
Use a Standard Template for Consistency
To a great extent, the DMP can, and should be standardized across projects for a consistent approach. When using a centralized biometrics model, where data services( data management, statistics, statistical programming) are conducted by a single provider, the development of such standard documents can represent an efficiency in the study set up, and also reduce the oversight burden for the sponsor. Indeed, for any trial project, a robust Data Management Plan template provides a solid starting point. One of the important challenges facing industry professionals today is the increasing complexity of clinical trials, and as such, great care needs to be taken to ensure the DMP accurately documents what actions will be taken with the trial data. Having a highly experienced data management team working on your project, with a track record of implementing innovative and complex trial designs, therefore, becomes increasingly important in this environment.
Feb 15, 2017 9:33:05 AM
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.
Feb 6, 2017 9:10:00 AM
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 standardization also brings significant benefits to the industry- in the CDISC 2014 Business Case (1), it is noted that:
“For those developing regulatory eSubmissions, using updated baseline numbers for the time and cost of getting a drug to market, it can be found that ~ $180M can be saved per submission (18% of the total cost). An average of two years can be saved off of an average 12-year clinical development program lifecycle – just by standardizing data”.
It’s therefore critical that the biopharma and CRO industries develop the next generation of data managers, statisticians and programmers with strong knowledge of the CDISC standards.
Angelo Tinazzi has more than 20 years’ experience in data-management and statistical programming and is Director of Clinical Data Standards and Data Submission at Cytel. He has been a member of the European CDISC Committee since 2015 and is a member of the CDISC ADaM team. Taking the next step in his journey as a data standards expert, Angelo is now a "candidate trainer" with CDISC –working towards becoming an “Authorized CDISC Instructor”. In this blog we find out more from Angelo about his experiences and the role of the CDISC trainer.
Dec 23, 2016 8:21:00 AM
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....
Dec 21, 2016 9:45:00 AM
December 18th 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 guidance Providing Regulatory Submissions In Electronic Format — Standardized Study Data (1) also notes that the requirement will include ‘all subsequent submissions, including amendments, supplements, and reports’ to the submission types.
With regard to other regulatory agencies position on CDISC, the Japanese Pharmaceuticals and Medical Devices agency ( PMDA) will now request CDISC compliant submissions after October 2016 with a certain transitional period. This will be fully mandatory by 2018. While the European Medicines Agency (EMA) is adopting a top-down approach and therefore more focused on topics such as data transparency, issues of data integration and interoperability will also form part of the EMA’s future plans.
With this in mind, any sponsor planning an NDA, BLA or other regulatory submission needs to make sure they are observing best practice with regards to CDISC. In this blog, we outline some of the key issues to bear in mind as you prepare for your data submission.
Dec 20, 2016 9:21:00 AM
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 regulatory references. There is sometimes a misconception that CDASH defines the layout of the CRF and eCRF. This is not the case. The function of CDASH is to define the naming conventions for the clinical database, and outline how variables are mapped to SDTM. It defines how questions should be formulated for data collection within the CRF and eCRF making use of standard CDISC controlled terminology. In this blog, we will provide an example of CDASH implementation.
Dec 6, 2016 10:18:00 AM
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. In this blog, we take a look at some of the key considerations to be addressed by data management across the different clinical development phases.