When Every Day Counts
While developing a vaccine for COVID-19, a Top 3 pharmaceutical company had an urgent need
Phase III-IV
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
Overcoming rapid growth challenges with process liquid preparation
A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation capacity in order to meet the demand for one of their client’s recently approved therapeutic
Internal Standard (IS) Variation Case Studies: Emerging from Three Common IS Challenges
The use of internal standards (IS) is essential for developing and applying liquid chromatography-tandem mass spectrometric (LC-MS/MS) quantitative bioanalytical methods.
ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Variation
Global regulatory standards govern bioanalytical method development, validation and the subsequent assays. When those standards are updated, industry stakeholders should actively partake in their evolution and prepare for the ensuing changes.
Why should you use clinical trial technology?
New, innovative clinical trial technology is helping to revolutionize the research landscape.
Unlock potential in buffer preparation
Consider how the right partner can help you scale faster, mitigate risks, and optimize resources.
Plan for success with process liquid and buffer preparation
Setting the groundwork for successful scale-up is essential for getting a therapeutic to market quickly and efficiently, but navigating the unknowns associated with this process can be challenging. Beyond procurement challenges, raw materials need to...
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.
CNS Drug Development―One Partner From Discovery to Market
As a leading partner in central nervous system (CNS) drug development, Altasciences’ in-house preclinical, clinical, bioanalytical, and manufacturing teams have decades of experience formulating, testing, and manufacturing pharmaceutical products that...
Drug Solubility and the Need for Speed
A growing number of new chemical entities are highly insoluble, leading to problems with bioavailability. Drug manufacturers therefore have to find ways of improving solubility if the product is to succeed. This also has to be done as quickly and...
Are You Prepared to Meet the New FDA Guidelines?
On April 15, 2022, the U.S. Food and Drug Administration issued a new draft guidance to clinical research sponsors on creating a plan to enroll more participants from underrepresented racial and ethnic populations, specifically Black or African American,...
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,...
2023 State of Clinical Trial Technology Report
Discover the trends shaping clinical trial technology in 2023, from Site Enablement to eISFs, integrations, and site-sponsor collaboration. This report includes insights from 450 sponsors, CROs, and sites, who shared what technology they’re investing in,...
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.
Because When It's On the Line... Capability Matters.
Baxter’s BioPharma Solutions business supports leading pharmaceutical companies in meeting their commercialization objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems and customized support services...
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.
Ensure a Flexible Supply Chain in Times of Global Turmoil
As major world events continue to unfold, every organization is contending with supply chain disruptions.
dPCR Case Study
Streamline your adoptive cell therapy program with digital PCR. Our team has a unique expertise in digital and quantitative PCR to support you in ensuring your adoptive cell therapy (ACT) meets safety regulations relating to VCN and RCL/RCR levels, even...
Is Your Ancillary Supply Chain Supporting Trial Success?
As the effects of the pandemic reverberate through global supply chains, Sponsors still face many hurdles in sourcing and managing ancillary supplies for clinical trials. Interruptions and delays that once felt like temporary inconveniences are now...
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.
Home Health in Clinical Trials — A Better Way to Meet Patients’ Needs
Meeting patient needs today is complicated. But there is one thing that can minimize their burden, improve retention, and maximize protocol compliance. But it requires a human touch.
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...
The APAC Advantages
Over recent years, the Asia-Pacific (APAC) region has become an emerging market for pharmaceutical and biotech innovation, including clinical studies.
Adapting supply chains to new ways of working
COVID-19 has changed the way we operate. We have adapted our supply chain solutions to meet our clients’ requirements while following World Courier standard procedures. Being flexible is key to develop contingency plans but selecting the right option...
What are the building blocks of DCTs?
How to create a seamless experience across eConsent, eCOA and more. Over the past year, tremendous progress was made toward digitizing and decentralizing the patient and site experience. While the industry introduced individual point solutions to...
Introduction to eLAS®
Clinical Ink has developed a unique offering — the electronic Lupus Assessment Suite (eLAS®) to address fundamental challenges impacting systemic lupus erythematosus (SLE) studies and the integrity of the study endpoints.
Deploy Configurable, Mixed-Modality ePRO Solutions, Fast
Real-Time, Integrated Data Capture With Unprecedented Freedom of Choice
Clinical Trials 2.0: A Fresh Approach to Systems and Data
This white paper explores the value of taking a fresh approach to clinical data management, its associated systems and ultimately the processes and roles that surround them. With the right technologies in place, companies can re-invent the traditional...
A Winning End-to-End Solution for Oncology Studies
Oncology clinical trials present a unique set of challenges for patients, study sites, and study sponsors. Using electronic patient reported outcomes (ePRO) in conjunction with agile methodology enables nimble, efficient clinical data management...
Exploring the Intricacies of the Immune System: A Practical Guide to Immune Monitoring Across Therapeutic Interventions
Immune monitoring has become an essential strategy for understanding, predicting, and monitoring the response of the immune system to therapeutic interventions.
Lessons Learned: Clinical Trials During a Pandemic
In a recent survey of clinical trial professionals (including pharmaceutical sponsors, CROs, site representatives and vendors), respondents reported that one of their most significant concerns was clinical trial patient recruitment and retention. This...
Global Pediatric Drug Development Collaboration: Part One
The pharmaceutical industry is unlike any other industry in that the products manufactured can dramatically improve, and even save, lives. This is especially the case when it comes to children. Although pediatric patients comprise a smaller population of...
Global Pediatric Drug Development Collaboration: Part Two
70% of medicines given to children have never been studied in pediatric populations. Children who need treatments represent a relatively small population. This alone presents unique challenges for pediatric drug development. Since the 1990s, authorities...
Outsourcing Analytical Testing for Biologics - A CRO's Perspective
Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed, proteins, given their chemistry, are the “most structurally complex and functionally sophisticated...