When Every Day Counts
While developing a vaccine for COVID-19, a Top 3 pharmaceutical company had an urgent need
Phase I-II
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.
PBPK modeling that saves you time and money
Understanding pharmacokinetic behaviors ahead of later-stage development means making informed decisions earlier. This enhanced capability helps your drug development projects meet tight timelines and budget objectives.
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...
Small Molecule development – getting it right
Small Molecule drug development is something more and more ambitious emerging pharmaceutical companies are taking on from end to end. But this path can be fraught with risk.
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...
A Guide Through the API Drug Development Pipeline
With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles addressing the many challenges for biotechs, this eBook is your guide to navigating the drug development...
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,...
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...
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.
The Complexities of Ophthalmic Drug Development
Ophthalmic drug development comes with a unique set of challenges that can be mitigated by working with an end-to-end solution provider with regulatory knowledge and scientific expertise in this therapeutic area. Partnering with a single integrated...
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.
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...
Planning Your First-In-Human Trial
A first-in-human (FIH) clinical trial is a significant milestone in the development of a potential new drug. A successfully conducted FIH trial provides a solid foundation of knowledge regarding the safety and exposure of an IP, at several dose levels,...
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...
Pediatric Formulations: Identifying & Addressing Children’s Needs
Developing formulations for pediatric patients poses unique challenges. The specific needs of children, which vary by age, mean the task goes beyond scaling down the dose of the adult formulation.
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...
Strategic Approach to Immunogenicity Assessment
In this issue of The Altascientist we provide a detailed overview on the different goals and challenges that are presented by the validation of immunogenicity assays to support nonclinical and clinical studies, including a case study.
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...
Clear Guidelines for IND/CTA
There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials.
The APAC Advantages
Over recent years, the Asia-Pacific (APAC) region has become an emerging market for pharmaceutical and biotech innovation, including clinical studies.
Planning Your Preclinical Assessment
There are many challenges associated with early drug discovery and development. Advancing your best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials.
Automating clinical trials for success
This article gives gives a brief overview of why automation is absolutely essential for clinical trial success.
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.
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...
Advancing Opportunities for Success in Central Nervous System Clinical Trials
The clinical development process for novel therapies that treat central nervous system (CNS) diseases is scientifically and medically complex, as demonstrated by low success rates.
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...
Virtual Trials: Trust in Experience, Trust in Lunexis™
From Infectious Disease to BYOD, We Set the Bar for Virtual Trials