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By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinicalresearch, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?
There are many clinical trial blogs out there, but what sets the best ones apart? Our favorites are the ones that don’t simply cover news — instead, they aim to be go-to sources for informed positions on how to improve the medical research process.
Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinicalresearch. Accelerate your clinicalresearch with our drug development digital solutions from Thermo Fisher Scientific.
These innovations promise to enhance the precision and efficacy of early-stage research, setting a solid foundation for subsequent clinical applications and enabling the development of more personalized medicine. In this blog post, we’ll focus on the preclinical innovations and trends expected to reshape biomarker analysis.
Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinicalresearch. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.
Clinicalresearch is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. The post The Value of ClinicalResearch first appeared on Advarra.
AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials. Partner with us to optimize your drug development process and drive innovation in the industry.
Artificial intelligence (AI) is transforming the clinicalresearch landscape. The post From Study Design to Submission: The Role of AI Throughout the ClinicalResearch Journey appeared first on Crucial Data Solutions. It is being used to optimize how data is collected, organized.
It is not hyperbole to say that data is transforming clinicalresearch at a breakneck pace. The post Don’t Drown in Data – ClinicalResearch Data Management Can be Easy, with a Little REST appeared first on Crucial Data Solutions. The critical need to.
The clinicalresearch industry is currently dealing with a great deal of uncertainty, with various solutions providers announcing layoffs often. The post In a Time of Uncertainty for ClinicalResearchers, Reliable Partners are Vital appeared first on Crucial Data Solutions.
This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs. FSP outsourcing is growing faster than FSO.
In the clinicalresearch space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.
In clinicalresearch, the advent of artificial intelligence (AI) is transforming the way study teams approach their work. The post The Digital Teammate: How AI is Changing How ClinicalResearch Teams Work appeared first on Crucial Data Solutions.
Many have noted that FDA has been slow to recover We’ve blogged before on FDA’s post-pandemic inspection work, writing about the resumption of both good manufacturing practice (GMP) and bioresearch monitoring (BIMO) inspections. In other words, the inspectional output was inversely proportional to the importance of clinicalresearch.
NCCRED was funded through the Strategy, and commenced in 2018, to build clinicalresearch capacity and work towards establishing evidence-based treatment approaches for both methamphetamines and other emerging drugs of concern. Why do a clinicalresearch priority setting study?
Decentralized clinical trials (DCTs) have emerged as a transformative approach in clinicalresearch, offering unique benefits that challenge the traditional models. In this blog post, we will delve into the decision-making process of whether to embrace DCTs or stick with conventional trials.
This blog focuses on regulatory writing, which involves the preparation of clinical study and regulatory submission documentation. There are two main areas in medical writing, medical communications and regulatory writing.
Maintaining regulatory compliance at research sites and institutions is no small feat – documents need to be updated and maintained in a consistent manner to ensure compliance. Advarra’s eRegulatory Management System (eReg) is designed to adapt to and streamline research site regulatory workflows.
The enterprise of delivering life-changing medicines to patients involves a complex ecosystem, and in many ways, three key players reside at the core: drug sponsors, the contract research organizations (CROs) that support them and the clinicalresearch sites directly engaging with patients in the trial. We can help.
Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S. The seven awardees included six early-stage trials (e.g.,
AI Innovations in Ophthalmic Research ARVO is one of the largest global conferences for ophthalmology research , attracting nearly 11,000 attendees from over 60 countries. Hosted by the Association for Research in Vision and Ophthalmology, it serves as a platform for exchanging cutting-edge research findings.
Implications for Future of ClinicalResearch R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach.
Guest Blog: Reflecting on the 2024 Society of Toxicology of Canada Symposium, by Ria Falvo, Director, Reporting pmjackson Fri, 01/31/2025 - 15:47 Ria Falvo, Director of Reporting, and Rina Massarelli, Associate Director of Safety Reporting, in Toronto, Ontario, for the 2024 STC Symposium. Tags Preclinical Research Weight 15
In our last blog, we brought up the topic of vaporware in clinicalresearch data management. Clinical trials require a. The post Avoiding Clinical Data Vaporware – Even More Questions to Ask eClinical Platform Providers appeared first on Crucial Data Solutions.
Gene therapy research is booming in the clinical setting. In this blog, we summarize the growth, risks, and regulatory requirements for gene therapy research. We also discuss how a centralized biosafety review process can benefit this type of research.
To protect human subjects in clinicalresearch, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. What Systems Integrate with an eTMF?
10 areas that may impact your organization The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinicalresearch standards. Staff training & protocol compliance: Are your protocols and procedures being updated to incorporate these core tenets of R3?
If there’s one constant in clinicalresearch, it’s change. With continual innovations and transformations, establishing a human research protection program (HRPP) can help many research institutions adapt to these changes while upholding the highest ethical standards.
The clinicalresearch industry, like many others, has continued to be challenged by staff turnover in recent years. Clinicalresearch organizations everywhere are seeing an influx of employees leaving their positions to go elsewhere. Understanding this issue is essential to a healthy research organization.
Moving research from concept to market is like conducting a symphony — there are numerous players and stakeholders, each bringing their unique expertise to work in harmony and advance a project. BioDAOs fund and incubate projects during the initial stages of translational research, often through IP-NFTs, even before a company is established.
Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders. This is where contact center services play a vital role.
With a decade of experience as regulatory counsel in the FDAs Center for Drug Evaluation and Research Office of Scientific Investigations, her experience will help Advarras clients and internal teams navigate the ever-shifting regulatory landscape for human subjects research. Sponsors often ask, How will the FDA view this?
These innovative approaches leverage technology and local clinicians to bring clinicalresearch directly to patients, shifting away from the traditional, site-centric model.
In the modern clinicalresearch environment, improving patient outcomes is both a regulatory imperative and an ethical priority. The post How to Improve Patient Outcomes Using eSource Software in Clinical Trials appeared first on Crucial Data Solutions.
Through the years, NIH has supported a total of 169 researchers who have received or shared 101 Nobel Prizes. This form of chemistry has made it possible for researchers to snap together, like LEGO pieces, molecular building blocks to form hybrid biomolecules, often with easy-to-track imaging agents attached.
Through their participation in clinicalresearch studies, they have given an extraordinary gift of hope to future generations! Choosing to participate in a research study is a very personal decision. However, when study volunteers participate in research, society benefits! Medical heroes are all around us.
But for the nusinersen clinical trials, children were most likely to benefit, and so the clinical trials began without first collecting data on adult research participants. Even though this was a big step for involving children in clinical trials, kids haven’t always been as fortunate. Why This Guidance Now?
In this blog post, we will explore 5 essential questions that clinical trial operations leadership and feasibility teams must consider in order to achieve true equity and parity in recruitment. This not only increases diversity in clinical trials but also ensures that all segments of the population are represented in drug development.
In clinicalresearch, innovations in technology are moving us down an exciting path, transforming traditional methodologies and paving the way. The post Wearables in Clinical Trials: Real Benefits Beyond the Hype appeared first on Crucial Data Solutions.
Over the past year, all of us working in clinicalresearch have seen a significant increase in the number of. The post The Year Ahead: What Does EDC Look Like In 2024 and Beyond? appeared first on Crucial Data Solutions.
The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology, and an increased demand for accelerated timelines in getting therapies to market. Each of these have contributed to a rapidly evolving clinicalresearch landscape.
He was promoted to Associate Director, Program Management , in 2022, and now oversees a team of program managers who guide end-to-end solutions, including preclinical , clinical , CDMO , regulatory , and bioanalytical solutions. Image blog-thumbnail-up-close-jason_1.jpg What Was your dream job as a child? jpg Weight 1
As the clinicalresearch industry becomes more centered on technology, perhaps one of its most underused solutions is the electronic consent (eConsent) platform. This blog outlines why adopting an eConsent platform is a beneficial and strategic step sites can take right now. eConsent Gives Sites Flexibility.
Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Research and Development: Pritelivir is being developed by AiCuris Anti-infective Cures, building upon research from Bayer. amcrasto@gmail.com NEW DRUG APPROVALS ONE TIME $10.00
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