Antidote

NOVEMBER 21, 2022

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.

Clinical Research 98

Clinical Research Research Clinical Trials Trials 98

Advarra

SEPTEMBER 14, 2023

In the clinical research 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.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

Agency IQ

AUGUST 18, 2023

FDA’s informed consent guidance gets a 21st century makeover The FDA has issued a new, final guidance on informed consent for clinical investigations – the first update since 1998. The FDA, HHS, and research and informed consent policies In the U.S.,

FDA 52

FDA Clinical Trials Clinical Research Regulations 52

Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

FDA 40

FDA Regulations Clinical Trials Production 40

Conversations in Drug Development Trends

JULY 9, 2024

It is important to ensure that patients provide truly informed consent and understand the terms of participation and that they require their own physician’s prescription post-study if they are to continue receiving GLP-1 therapeutics.

Clinical Research 52

Clinical Research Treatment Research Clinical Trials 52

National Drug & Alcohol Research Centre Blog

JULY 13, 2021

NCCRED was funded through the Strategy, and commenced in 2018, to build clinical research capacity and work towards establishing evidence-based treatment approaches for both methamphetamines and other emerging drugs of concern. Why do a clinical research priority setting study?

Clinical Research 52

Clinical Research Research Clinical Trials Trials 52

PPD

JANUARY 5, 2023

In an industry survey led by PPD, Thermo Fisher Scientific’s clinical research business, rare diseases emerged as a top therapeutic area in drug developers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space.

Disease 52

Disease Trials Clinical Trials Clinical Research 52

Advarra

MARCH 31, 2023

Among the various regulatory bodies providing oversight on clinical research, only the institutional biosafety committee (IBC) has a purview specific to research involving engineered genetic materials. The post Risk Assessment for use of Engineered Genetic Materials in Clinical Research appeared first on Advarra.

Engineering 52

Engineering Clinical Research Research Virus 52

PPD

OCTOBER 12, 2023

Parallels between pharmacokinetic (PK) analyses for CGTs and immunotherapies, conducted through PCR-based assays and plate-bound antibody assays, respectively, can inform a successful approach. The post Informed Design of Bioanalytical PCR Assay Testing Parameters appeared first on PPD Inc.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

Olympian Clinical Research

MARCH 19, 2024

Participating in a clinical trial is a significant decision that can have profound benefits, not only for the individual participant but also for future patients and the broader medical community. Even if the trial does not provide a direct health benefit, the information gathered can help others and advance medical research.

Clinical Trials 52

Clinical Trials Trials Clinical Research Nurses 52

Antidote

SEPTEMBER 22, 2023

Connecting patients with clinical research opportunities is our mission here at Antidote, but often, we find that misconceptions can serve as barriers to achieving this goal. It’s important to carefully weigh the pros and cons of participating in a clinical trial but to do this effectively, it’s critical to have accurate information.

Clinical Trials 122

Clinical Trials Trials Clinical Research Research 122

Broad Institute

OCTOBER 3, 2023

Broad Clinical Labs established to expand clinical services By Leah Eisenstadt October 3, 2023 Breadcrumb Home Broad Clinical Labs established to expand clinical services Formerly the Clinical Research Sequencing Platform, the cutting-edge laboratory at the Broad Institute is poised to further accelerate clinical genomics.

Clinical Research 131

Clinical Research Clinical Trials Laboratories Trials 131

On Medicine

FEBRUARY 8, 2024

As noted, older people are under-served by clinical research and CHARMER has made a concerted effort to involve public and patient representatives in all CHARMER study activities, including as co-applicants. This is reflective of the collaborative approach the CHARMER programme has adopted since its inception.

Hospitals 109

Hospitals Trials Doctors Clinical Research 109

PPD

FEBRUARY 19, 2024

Changes to an organization’s infrastructure include: Day-to-day activities of employees Modifications to clinical trial management systems, standard operating procedures (SOPs) and work instructions (WI) Cross-functional training Clinical trial operations (e.g.,

Clinical Trials 96

Clinical Trials Regulations Trials Clinical Research 96

Olympian Clinical Research

APRIL 18, 2023

To learn more about the causes and treatments for HS, Olympian Clinical Research ( OCR ) is hosting a research study on the condition. If you suffer from hidradenitis suppurativa and are considering participating in an HS research study with OCR, this guide will give you an idea of what to expect.

Research 52

Research Clinical Research Doctors Treatment 52

Quanticate

JUNE 13, 2024

When relying on clinical research to introduce new products to the market, adhering to regulations like Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and CFR Part 11 is mandatory. All trials must comply with country-specific regulations set by regulatory bodies.

Clinical Trials 59

Clinical Trials Laboratories Regulations Clinical Research 59

PPD

MAY 18, 2023

Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinical trial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinical research business of Thermo Fisher Scientific. PPD has local teams across Europe and the U.S.

Clinical Trials 86

Clinical Trials Trials Clinical Research Doctors 86

Broad Institute

FEBRUARY 19, 2024

Over the past decade, scientists have developed these risk scores for dozens of diseases, including heart disease, kidney disease, diabetes, and cancer, with the hope that patients could one day use this information to lower any heightened risk of disease. By Sarah C.P. What’s the score?

Disease 124

Disease Clinical Research Research Treatment 124

Conversations in Drug Development Trends

APRIL 8, 2024

Expertly managed clinical assessments by a team with fastidious attention to detail optimizes precision and reliability and helps you successfully navigate the complex terrain of clinical research. Our cohesive approach, characterized by its agility, precision, and collaborative spirit, transforms our partnerships.

Clinical Trials 75

Clinical Trials Clinical Research Trials Compliance 75

Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. Risks to CtQs factors should be proactively managed and risk language/monitoring adjusted according to new and changing information during the clinical trial.

Clinical Trials 52

Clinical Trials Trials Clinical Research International 52

Advarra

DECEMBER 12, 2023

The clinical research industry, like many others, has continued to be challenged by staff turnover in recent years. Clinical research organizations everywhere are seeing an influx of employees leaving their positions to go elsewhere. This can lead to further delays and costs.

Clinical Research 52

Clinical Research Clinical Trials Packaging Trials 52

Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

Trials 52

Trials Clinical Trials Clinical Development Clinical Research 52

SCIENMAG: Medicine & Health

OCTOBER 5, 2023

The purpose of the award is to create the Access for All in ALS (ALL ALS) Consortium to conduct clinical research that will include ALS patients nationwide, generating a longitudinal biorepository linked to detailed clinical information that will be made available to research scientists throughout the world using a web-based portal.

Research 52

Research Clinical Research 52

Advarra

JUNE 14, 2024

Centralization of Documents When multiple studies share regulatory documents, it is most efficient to centralize them, often done electronically in an eRegulatory management system (eReg).

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

Olympian Clinical Research

AUGUST 19, 2022

In addition, clinical research may provide new information and breakthrough treatments. . Your child’s pediatrician will also be able to provide you with more information about pediatric psoriasis and the available treatment options. The Benefits of Clinical Research for Pediatric Dermatology Conditions.

Clinical Research 52

Clinical Research Treatment Doctors Licensing 52

Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. of respondents reported they know what clinical trials are.

Clinical Trials 52

Clinical Trials Trials Clinical Research 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

Conversations in Drug Development Trends

JANUARY 24, 2024

However, clinical research around Fragile X is considerably robust, making the possibility of clinical trial participation a potential motivation for parents to choose to undergo genetic testing for their children. These datasets can help find providers and patients based on genetic information.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Olympian Clinical Research

NOVEMBER 9, 2022

The more you know, the better equipped you’ll be to make informed decisions about your care. Change Your Outlook with Olympian Clinical Research. At Olympian Clinical Research, we are dedicated to helping those with bullous pemphigoid and other rare conditions through clinical research trials.

Treatment 52

Treatment Clinical Research Immune Response Therapies 52

Advarra

MARCH 5, 2024

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. Note: This article was originally published December 4, 2019, and has been updated to include new and clarifying information.

Regulations 52

Regulations Clinical Research Research Government 52

Vial

JUNE 18, 2024

Black/African American and Hispanic/Latino adults in terms of prevalence, incidence, and outcomes, these populations are underrepresented in AD clinical research. On the other hand, community members identified a lack of information and trust in their care team as barriers. Although AD disproportionately affects U.S.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

Clinical Trials 59

Clinical Trials Trials Clinical Research Disease 59

PPD

AUGUST 14, 2024

According to research commissioned by the PPD clinical research business of Thermo Fisher Scientific, 55% of respondents reported patient recruitment in clinical trials as the top challenge facing their organization, followed closely by increasing trial complexity.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Advarra

AUGUST 1, 2023

Efficient and compliant data capture can make or break the success of a clinical research trial. Using eSource Instead of Paper Designed to help sites accomplish necessary data capture activities and workflows, eSource enables research staff to capture all necessary information for both research and standard-of-care purposes.

Compliance 52

Compliance Clinical Research Trials Research 52

Olympian Clinical Research

MARCH 25, 2019

“SPRAVATO will offer the first new mechanism of action in 30 years to treat this debilitating disease, continuing Janssen’s 60-plus-year history and commitment to research that make a difference for people living with mental illnesses, including severe mood disorders.” [1]. If you’d like more information on SPRAVATO TM click here !

Clinical Research 70

Clinical Research Clinical Trials Treatment FDA 70

Conversations in Drug Development Trends

AUGUST 10, 2023

We Have an Opportunity to Improve from Past Experiences The history of clinical research is full of shortcomings, including the unethical treatment of research participants and the exclusion of members of racial and ethnic minority groups and the LGBTQIA+ community.

Science 98

Science Clinical Trials Trials Clinical Research 98

H1 Blog

MAY 4, 2023

Insights for Thought Leading Stakeholder Engagement to Decrease Medication Non-Adherence Pharmaceutical companies have long recognized the importance of engaging key opinion leaders (KOLs) to gain insight and support for clinical research, drug development, and medical education.

Pharmaceutical Companies 52

Pharmaceutical Companies Clinical Research Pharma Companies Pharmaceuticals 52