Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO?

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Vial

DECEMBER 13, 2023

Gastrointestinal (GI) clinical research has evolved over time. In this article, we explore the latest trends and innovations, including the use of big data and artificial intelligence (AI), which have the potential to revolutionize the design of GI clinical research.

Clinical Research 52

Clinical Research Research Clinical Trials Trials 52

Agency IQ

AUGUST 18, 2023

The new guidance offers recommendations for institutional review boards (IRBs), investigators and sponsors on key aspects of informed consent, significantly expanding FDA’s recommendations on several key topics, including reimbursement for research participation. The FDA, HHS, and research and informed consent policies In the U.S.,

FDA 52

FDA Clinical Trials Clinical Research Regulations 52

Advarra

OCTOBER 17, 2023

However, in order to maintain a successful research program and ensure long-term growth, a site also needs to focus on running their organization as a business. Visibility into and control of the financial aspects of a site’s research portfolio are key to building a successful financial site workflow.

Clinical Research 52

Clinical Research Research Clinical Trials Compliance 52

Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

Clinical Research 52

Clinical Research Therapies Research Vaccine 52

PPD

MARCH 11, 2025

Breaking through research barriers Challenge #1: Small groups of patients Rare diseases impact a small number of individuals, making it difficult to recruit enough participants for clinical trials. DCEs typically produce population-level estimates and require large samples to be robust.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

PPD

JUNE 24, 2024

Explore the unique aspects of mega trials, the challenges they pose to vaccine developers, what the future holds for these large, complex trials, and how a partnership with an experienced provider of clinical research solutions can enable success.

Vaccine 97

Vaccine Trials Clinical Trials Laboratories 97

The Pharma Data

NOVEMBER 26, 2020

. Machine learning advances and growing dental digitization have ushered in new AI-based tools to support patient care, practice management, insurance claims review, and clinical research.

Clinical Research 52

Clinical Research Research 52

Quanticate

APRIL 12, 2024

The landscape of clinical research is undergoing major changes with virtual clinical trials driving these transformations. These innovative trials promise to revolutionise the way medical research is conducted, making it more accessible, efficient, and patient-centric than ever before.

Clinical Trials 52

Clinical Trials Trials Clinical Research Disease 52

Drug Target Review

DECEMBER 16, 2024

In this interview, she discusses her path to becoming a physician and clinical researcher, the obstacles she faced, and her dedication to improving outcomes for cancer patients. Dr Hingorani also shares insights into the strengths women bring to STEM, the importance of mentorship, and her vision for the future of oncology research.

Medical Schools 52

Medical Schools Clinical Research Drug Development Trials 52

Agency IQ

DECEMBER 11, 2023

At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. So far, the key takeaway was that both industry and regulators are still identifying best practices on setting enrollment targets in their research plans.

Research 52

Research Clinical Research FDA Regulations 52

Cytel

DECEMBER 16, 2022

Bayesian methods have been playing a key role in transforming clinical research, and Bayesian topics are frequently featured in Cytel’s Perspectives on Enquiry and Evidence. Our new ebook features a set of articles exploring various topics related to Bayesian statistical methods. Topics include:

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Development 52

Olympian Clinical Research

MARCH 3, 2020

There’s no doubt that research volunteers play a significant role in getting these vital solutions out on the market for the people in need. Sometimes people are afraid to enroll in a clinical trial out of fear, confusion, or misinformation. What is a clinical trial? Enrolling Studies.

Clinical Trials 52

Clinical Trials Trials Clinical Research Treatment 52

Cytel

DECEMBER 27, 2022

Bayesian methods have been playing a key role in transforming clinical research, providing a variety of new opportunities for efficient and flexible clinical trials. Here are some of our most-read articles on Bayesian methods in 2022. Bayesian topics are frequently explored in Perspectives on Enquiry and Evidence.

Clinical Trials 52

Clinical Trials Clinical Research Trials Research 52

Agency IQ

AUGUST 30, 2024

many types of clinical research must comply with regulations intended to protect the rights of research participants. Informed consent is one of the three foundational protections for research involving human subjects.

FDA 40

FDA Regulations Clinical Trials Production 40

KIF1A

JULY 1, 2023

But drug R&D is an uncertain process, and many therapeutics get shelved during preclinical or clinical research, before they ever reach a patient. It requires a deep look at former products that ended at various stages of research and development.

Small Molecule 98

Small Molecule FDA Approval Disease Pharmaceutical Companies 98

Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. The post IBC vs. IRB: What’s the Difference? appeared first on Advarra.

Engineering 98

Engineering Therapies Regulations Research 98

Conversations in Drug Development Trends

FEBRUARY 6, 2023

For a deep look into the best practices and considerations for including genetic testing in your clinical development strategy, read this article by our Aman Khera, Vice President, Global Head of Regulatory Strategy and Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Diseases. Read the full article!

Clinical Trials 52

Clinical Trials Trials Disease Clinical Development 52

Agency IQ

MARCH 1, 2024

Notably, he shared this information on his Twitter account, which was later scrubbed clean of his Tweets when Stephen Hahn took the helm of the agency, and is therefore no longer available ( see here for a Regulatory Focus article summarizing Gottlieb’s statements ).

Government 40

Government FDA Biosimilars Regulations 40

Vial

MAY 28, 2024

In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization) , two leading technology organizations, are revolutionizing the way clinical research is conducted.

Clinical Trials 52

Clinical Trials Clinical Research Trials Compliance 52

Conversations in Drug Development Trends

OCTOBER 31, 2023

Discover how to strengthen site partnerships, develop a strong sponsor-CRO partnership, earn a patient’s confidence during a study, and more in our article: Trust: The Key to Operational Success in Post-COVID Oncology Trials.

Trials 75

Trials Clinical Trials Clinical Development Clinical Research 75

Chemical Biology and Drug Design

NOVEMBER 1, 2023

Abstract Kaempferol is the active ingredient of Er-Xian decoction (EXD), a traditional Chinese medicine formula used clinically to treat ovarian dysfunction, but the mechanism of kaempferol relieving age-related diminished ovarian reserve (AR-DOR) is still unclear.

Regulations 100

Regulations Treatment Clinical Research Research 100

thought leadership

JULY 20, 2023

This article has been updated since it's original publication date. Good clinical practice ( GCP ) is an international ethical analysis and scientific quality standard for designing, conducting, and auditing clinical trials that involve the participation of human subjects.

Clinical Trials 40

Clinical Trials Trials Clinical Research International 40

Vial

FEBRUARY 8, 2024

In recent years, however, clinical trials have become increasingly complex, adding burden to research teams and clinical research sites. Starting with describing challenges faced in managing clinical trials, we explore how CROs address challenges and how sponsors benefit from partnering with CROs.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111

Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

FDA 40

FDA Therapies Clinical Trials Disease 40

Advarra

AUGUST 8, 2023

Risks and Regulatory Requirements Most clinical researchers are familiar with the regulatory requirements pertaining to the FDA phases of review as well as with IRB review. Note: This article was originally published September 18, 2019, and has been updated to include new and clarifying information.

Therapies 52

Therapies Research Engineering Clinical Research 52

Agency IQ

FEBRUARY 2, 2024

Appearing online December 26, 2023 in The Lancet , The review article’s “10 things you should know” approach highlights the importance of early engagement with regulators and establishing strong clinical research networks, and emphasizes how an adaptive trial design can boost efficiency, among several other points.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

Agency IQ

AUGUST 18, 2023

The new guidance offers recommendations for institutional review boards (IRBs), investigators and sponsors on key aspects of informed consent, significantly expanding FDA’s recommendations on several key topics, including reimbursement for research participation.

FDA 40

FDA Regulations Trials Research 40

Agency IQ

MARCH 1, 2024

9 – Advertising for medical devices and in vitro diagnostic medical devices Webinar/ Seminar ( OPEN ) Czech State Institute for Drug Control (NISZP) 3/25/2024 3/25/2024 Clinical Trials Information System Webinar: Last Year of Transition Webinar/ Seminar ( OPEN ) EMA 3/25/2024 3/25/2024 Next steps for clinical research in the U.K.

Regulations 40

Regulations Biosimilars Clinical Trials Production 40

Agency IQ

AUGUST 11, 2023

These inspections are used by FDA to assess sites involved in clinical research, and involve activities such as inspections, data audits and more. A core focus of BIMO is on clinical data integrity and uncovering mistakes or outright clinical trial fraud.

FDA 40

FDA Compliance Clinical Trials Pharmacokinetics 40

Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Drug Target Review

APRIL 7, 2025

About the author Dr Cyril Clarke, Vice President, Therapeutic Area, GMI Drug Development and Consulting, ICON Biotech Clarke is a clinical pharmacologist with over 30 years experience in clinical research; seventeen of which are within industrial clinical pharmacology.

Clinical Development 59

Clinical Development Clinical Trials Clinical Pharmacology Trials 59

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation.

FDA 40

FDA Research Clinical Trials Trials 40

Vial

DECEMBER 11, 2023

Despite the essential role of the clinical research industry, initiating a clinical study at a new site often takes a considerable amount of time, which can postpone the overall timeline of the research. The study also found that 11% of sites are never activated, meaning resources spent on these sites are wasted.

Clinical Trials 52

Clinical Trials Clinical Research Trials Research 52

Vial

JUNE 24, 2024

The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.

Clinical Trials 52

Clinical Trials Trials Clinical Research Treatment 52

Vial

APRIL 10, 2024

This article provides a comparative overview of Vial and IQVIA. The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. increase on a reported basis and an 4.8%

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52