Quanticate

JULY 5, 2024

Good Clinical Practice (GCP) affects a variety of entities, including sponsors, contract research organisations (CROs), and investigator sites. In our article we look into the potential implications of E6(R3) for the future of clinical studies and how organisations can best prepare for these changes.

Clinical Research 111

Clinical Research Drug Development Treatment Research 111

Advarra

OCTOBER 17, 2023

Research sites play a pivotal role in clinical trials, responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. 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

PPD

MARCH 11, 2025

While individual rare diseases affect populations that are small in numbers, collectively they impact millions globally, posing significant health and research challenges. This solution allows researchers to enhance the robustness of their control populations, minimize bias and provide a real-world context to trial outcomes.

Drug Development 52

Drug Development Clinical Trials Disease Trials 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

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

Drug Target Review

DECEMBER 16, 2024

Dr Pooja Hingorani, Senior Medical Director of Oncology Early Development at AbbVie , shares her journey in STEM, from her early days in New Delhi to her impactful career in oncology research and drug development. Opportunities in clinical research and drug development were not always easy to come by.

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

Advarra

AUGUST 8, 2023

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.

Therapies 52

Therapies Research Engineering Clinical Research 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

Advarra

SEPTEMBER 30, 2022

Is the clinical research industry winning or failing at innovation? Despite the fast pace of medical innovation, the lack of consistency between technology systems managing these advancements ultimately inhibits research progress. . Has innovation really succeeded in clinical research if this is the state we’re currently in?

Research 52

Research Clinical Research Trials FDA Approval 52

Olympian Clinical Research

MARCH 3, 2020

Many of the life-changing medical treatments that are available for patients have all been tested through a research study. 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. What is a clinical trial? You Can Help Impact Future Generations.

Clinical Trials 52

Clinical Trials Trials Clinical Research Treatment 52

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. IRBs are tasked with protecting research subject’s rights and welfare. How are IBCs Different from IRBs?

Engineering 98

Engineering Therapies Regulations Research 98

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

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

KIF1A

JULY 1, 2023

Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. Using similar logic, researchers measured the movement of KIF1A homodimers (a pair of healthy KIF1A motors, or a pair of mutant KIF1A motors).

Small Molecule 98

Small Molecule FDA Approval Disease Pharmaceutical Companies 98

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

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. However, HHS’ regulations only apply to research that is directly conducted or supported by the U.S.

FDA 40

FDA Regulations Clinical Trials Production 40

The Pharma Data

NOVEMBER 5, 2020

Drawing upon 50 years of expertise in clinical research, biopharmaceuticals, biotechnology and drug discovery, Dr. Van Kampen excels as the chief executive officer of The Van Kampen Group, which assists other companies in research and liaisons with government and industry regarding licensing products for commercial use.

Research 52

Research Vaccine Doctors Pharmaceuticals 52

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

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

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

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

Drug Target Review

MARCH 4, 2025

Phenomix Sciences, built on over a decade of clinical research at the Mayo Clinic, is disrupting this outdated approach. The research demonstrated that obesity is not one disease, but many; each of which should be treated with different interventions, says Bagnall.

Therapies 52

Therapies Treatment Clinical Trials Science 52

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

Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. How do CROs solve the challenges of managing clinical trials?

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Codon

JULY 21, 2024

Xander Balwit offers concrete proposals for raising the welfare of animals used in biomedical research for our final article in Issue 03. Of course, AA and P-line rats are not the only research animals bred for the study of disease. We’ll be on a brief hiatus for the next few weeks as we prepare for the next Issue!

Research 124

Research Engineering Disease Science 124

Advarra

MARCH 5, 2024

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. Understandably, this can cause confusion for researchers working with multiple IRBs. The post Reporting to the IRB: Investigator Noncompliance appeared first on Advarra.

Regulations 52

Regulations Clinical Research Research Government 52

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.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Advarra

DECEMBER 1, 2022

In the past several years, Health and Human Services (HHS) Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) have announced and/or implemented new regulations to address the challenges of conducting clinical trials involving multiple research sites.

Regulations 52

Regulations Compliance FDA Clinical 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. government, so FDA’s regulations are technically parallel to HHS’.

FDA 40

FDA Regulations Trials Research 40

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

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

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

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

Drug Target Review

SEPTEMBER 28, 2023

After that, I spent over a decade at a large instrument and genomics company working in, and then leading, research and development. Could you share an example of a specific project or research that you have worked on and the impact it has had in your field? This has a positive impact not only on research but on sustainability as well.

DNA 116

DNA Organic Chemistry Science Virus 116

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This article provides a comparative overview of Vial and IQVIA. IQVIA has a vast collection of healthcare information, including over 1.2

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52