Saama accelerates data review processes
In this new infographic, learn how Saama accelerates data review processes. Only Saama has AI/ML models trained for life sciences on over 300 million data points to identify discrepancies in your data.
Data management
More Data, More Insights, More Progress
The sponsor’s clinical development team needed a flexible solution to quickly visualize patient and site data in a single location
When Every Day Counts
While developing a vaccine for COVID-19, a Top 3 pharmaceutical company had an urgent need
Clinical Data Automation: The Time is Now
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Using Define-XML to build more efficient studies
It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets and variables, what terminology is used etc.
Three ways to leverage AI in Clinical trials right now
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Why should you use clinical trial technology?
New, innovative clinical trial technology is helping to revolutionize the research landscape. COVID-19 demonstrated that clinical trials can be run much more efficiently and faster than the industry previously imagined
Automated metadata management in clinical trials
When it comes to efficient clinical study build, content is king. Most importantly: metadata content. In this blog, we explore the role of metadata in clinical trials, the benefits of automating metadata management, and how to implement standardization...
Validate clinical study data with Formedix CORE
In April 2023 at the CDISC Europe Interchange, we launched Formedix CORE, the first free-to-use, downloadable application encompassing the CDISC Open Rules Engine (CORE). In this blog, we look at CORE projective objectives, benefits and how Formedix CORE...
SDTM supplemental qualifiers explained
What are SDTM supplemental qualifiers? In short, these are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard. In this blog, we'll take a detailed look at supplemental qualifiers, with examples.
4 Warning Signs Your Research Site Is in Trouble
You want your clinical research practice to be a success for your business and your patients, but how can you tell if it’s in trouble? Read this article to learn the four warning signs you should keep an eye out for, as they often spell operational and...
ODM and CDASH in CRF design
The lesser-known Operational Data Model (ODM) standard is often overlooked as it's not required by any regulators. So, why should you be interested in it? In the post, Formedix explains how the ODM can be used as a standard way to define forms,...
How Sponsors Reduce Chaos in Decentralized Trials
89% of research sponsors currently use and expect to continue the use of decentralized technologies and methods, according to our state of the industry survey. This rapid technological development will make clinical trials more accessible to...
Standardizing data with NCI controlled terminology
The use of consistent terminology within and between studies is critical to enabling an efficient trial process. CDISC standards such as CDASH, SDTM, SEND and ADaM standardize the structures to use when collecting and submitting data, but what about the...
How a Clinical MDR Helps with Data Quality
This article covers the many ways a clinical metadata repository helps with data quality in the clinical trial process, and how it ultimately helps to get compliant clinical studies submitted faster to regulatory bodies.
Optimizing Adherence in DCTs
Prioritizing greater patient-centricity and creating an opportunity to reach unprecedented patient groups, decentralized and hybrid clinical trials are becoming more widely adopted.
PPD is Supporting Complex EU DCTs
PPD supports European DCTs and clinical trial sponsors with a holistic and comprehensive approach
What should a clinical metadata repository do?
Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your clinical trials. This article explores the features that a clinical MDR software should have.
Helping Trial Sites Overcome Prevailing DCT Challenges
As a CRO, PPD (part of Thermo Fisher) can help guide the future of clinical research. Its depth of experience with decentralized clinical trials (DCTs) — all over the world and of many design types — enables PPD to provide insight and feedback-based...
Using SDTM, ADaM, and SEND
This article gives an overview of SDTM, ADaM, SEND and ARM, and discusses how these CDISC standards fit in with the wider clinical trial process, and how companies in the pharmaceutical industry can get maximum benefit from them.
How to design an effective CRF
CRFs and eCRFs are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical products.
Automating clinical trials: Why it's essential
Automation is used to improve the accuracy of results in the clinical trial process from study setup through to submission.
How clinical trial software can optimize trials
Companies often have to conduct multiple clinical trials at the same time, which means they've got to be efficient, and compliant with industry regulations. They need to be able to see and manage their clinical trials effectively so they can improve...
Governing and Maintaining Clinical Data Standards
Investing in data standards plays a huge role in improving the quality of clinical studies. But often, people don’t use the standards correctly, there are too many variations, or the standards keep changing.
What the Best Clinical Study Build Pros Do
Getting your clinical study designed and built ready for data collection takes A LOT of work and expertise… you've got to do all your CRF designs; keep up with protocol changes; add the annotations; make sure everything aligns with CDISC standards.
BMS Adopts a New Clinical Data Architecture
In this Case Study, you will learn how Bristol Myers Squibb optimized their data review processes to streamline and improve access to their data. By implementing a solution that complemented their EDC system, BMS has found great success in alleviating...
How The Supply Chain Has Been Impacted By COVID-19
The pharmaceutical industry had to adapt quickly to the pandemic if it was to continue to supply important medicines, while also racing to develop vaccines and treatments.
How Can You Avoid Delays in Your Trial? - Strategies for Comparator Sourcing
An optimized approach to comparator sourcing can improve inventory management and supply chain performance. This article summarizes key factors to comparator sourcing success, different comparator sourcing strategies, common pitfalls to avoid, the...
The ryze-elluminate integration in clinical trials
The integration between Formedix's ryze CMDR and eClinical's elluminate CDR maximizes automation across the end-to-end clinical trial lifecycle. Read this paper to find out more about the live integration between the two best-in-class softwares, ryze and...
Achieve Clean Data Sets Faster
In this case study, you will learn how Karyopharm Therapeutics simplified their data flow and reduced manual work across a diverse pipeline of clinical trials.
For eCOA Success, Look For The Four S's
For an effective eCOA platform that can meet any protocol requirements, study teams need more than just an app. Download this perspective paper to learn about the four pillars of eCOA success.
Opportunities to Accelerate Decentralized Trials
Take a deeper look into the current state of data sources, organization, and analytics in this white paper. You will learn about their impact and the opportunities that exist to accelerate decentralized and digital trials.
The Clinical Development Digitization Guide
Take a deeper look into the key components of preparing for the digitization of today's clinical trials in this white paper. You will learn the necessary steps organizations must take to embrace the transformation of processes that will usher in a new...
What’s Next for mRNA?
Now that the pharma industry and regulators have significant data on safety and efficacy of mRNA vaccines, many companies are looking beyond infectious disease to potentially develop therapies for a variety of indications.
SmartSignals Study Oversight
Today, sponsors and study teams often struggle to support the growing variety and volume of clinical data. The right technology thought will help your study teams conduct comprehensive reviews of all the standardized data at once.
The APAC Advantages
Over recent years, the Asia-Pacific (APAC) region has become an emerging market for pharmaceutical and biotech innovation, including clinical studies.
Optimizing Processes for Modern Digital Trials
Modern digital trials have sparked a new need within life sciences organizations for optimized and scalable clinical data processes & strategies. This new era of clinical trials has brought with it a dramatic influx in speed, variety, & volume of...
The Case for a Clinical Data Strategy
Being data-driven is top-of-mind for many life sciences companies, but actually turning that idea into action is easier said than done. To effectively centralize, analyze, and manage the ever-growing volume and variety of your clinical data, you need to...
How Can a Supply Chain Dashboard Yield Greater Clinical Trial Insights, Cost Control, and Efficiency?
With 1 in 10 Sponsors identifying a lack of technology integration as their biggest pain point, Deighton Liverpool, Ancillare’s Chief Information Officer addresses the critical need. Dive into what Ancillare is doing to bring sophisticated Clinical Trial...
Efficient Clinical Supply Management & Forecasting
How can clinical supply management benefit your trials? Download this eBook to explore how you can drive excellence within the forecasting process, as well as how to utilize forecasting throughout the clinical study to better plan clinical supply budgets...
Proof of Concept: Virtual Site Selection Visit (SSV)
The recent pandemic inspired Bayer to a proof-of-concept (POC) study that identified a viable solution for replacing in-person site selection visits. The big pharma company hoped that in doing so, their CRAs could remotely complete monitoring activities...
COVID-19 Vaccine Studies Succeed with Support from Signant Health
Signant helped a leading sponsor meet accelerated timelines while generating high-quality COVID-19 vaccine safety and efficacy endpoint data.
Paper vs ePRO Data Collection Methods
Are you curious why more Sponsors choose digital data collection methods over the traditional pen and paper? Read this recent white paper to discover the common risks associated with paper. You’ll also learn why industry experts predict that electronic...
GLP Tissue Cross Reactivity Testing
Precision for Medicine's unique combination of research services and tissue procurement capabilities form the pillars of our GLP Tissue Cross Reactivity (TCR) Services.
Automating clinical trials for success
This article gives gives a brief overview of why automation is absolutely essential for clinical trial success.
Next Generation Immune Monitoring: Epiontis ID
Rapid and consistent results, flexibility in sample type, and minimal sample processing to support global clinical studies
New Clinical MDR & Automation Platform by Formedix
Formedix, a leading provider of clinical trial software solutions, announces the launch of ryze, an innovative all-in-one cloud-based clinical metadata repository (MDR) and study automation platform. ryze has been specifically developed to accelerate and...
Top Pharmaceutical Company Drives Strategic Resource Management and Portfolio Planning
With a portfolio of clinical studies that fluctuates year over year depending on the portfolio, resource and cost constraints are a constant issue. Questions such as how many patients will participate in clinical studies? How will the studies be paid...
Advanced Analytics Driving Interactive Data Exploration in Study Teams
At Novartis, TIBCO Spotfire® enterprise analytics is a key tool for interactive graphical data analysis for preclinical and clinical studies. Using interactive graphical data exploration provides an efficient, powerful, and flexible tool to improve...
Empowering Clinical Trial Sponsors with Analytics
Is your Clinical Data Review creating problems or solving them? Take Control of Your Data. PerkinElmer Informatics Clinical Solutions, powered by Tibco Spotfire, are the most efficient, scalable, and centralized offerings for clinical data analysis.