PPD

NOVEMBER 16, 2023

In clinical research, access to timely, curated data is critical to mitigate risk and drive operational effectiveness. One common challenge for clinical trial sponsors is coordination of data across an array of vendors and systems. Expertise to easily assimilate diverse data systems and anticipate gaps.

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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?

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Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. The success of clinical research hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

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Advarra

AUGUST 8, 2024

The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Non-EU companies must comply with the AI Act if their AI systems are used in the EU market.

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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.

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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.

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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.

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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.,

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Advarra

DECEMBER 1, 2022

The research informed consent form (ICF) is designed to provide prospective participants with the necessary information to make an informed decision about whether to participate in a clinical trial. Why HIPAA in Research? PHI is a subset of what is termed “individually identifiable health information.”

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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.

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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.

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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.

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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?

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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.

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Advarra

MARCH 14, 2023

AMCs and Health Systems Integrating a clinical trial management system (CTMS) enables the regulatory team to pull protocol details and place them into eReg. This saves organizations time while also ensuring consistency between information added in each platform.

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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.

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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.,

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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.

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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 !

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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.

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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.

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Olympian Clinical Research

SEPTEMBER 3, 2020

Sit back and take a look at yourself, your life, and your depression – understand how things affect you, what situations may overwhelm you or exacerbate your depression, and take steps to improve your life and do what’s best for you based on that information.

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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.

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Advarra

NOVEMBER 14, 2024

The draft guidance highlights several key points pertinent to international trials: Diversity of expertise: KOLs with varied backgrounds and expertise enhances the DMC’s ability to address complex clinical and safety issues, and is crucial for interpreting data accurately and making informed decisions. local standards of care).

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PPD

SEPTEMBER 6, 2023

Examples of Hybrid Outsourcing Strategies for Clinical Trials For biotech and biopharmaceutical organizations, a strong CRO partner with broad experience in both FSO and FSP engagements is necessary to guide the right mix of service models to use.

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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.

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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. BY LAURA DIANGELO, MPHAUG 17, 2023 12:08 AM CDT The FDA, HHS, and research and informed consent policies In the U.S.,

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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.

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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.

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PPD

AUGUST 5, 2024

Global expertise and 7 key lessons learned The PPD clinical research business of Thermo Fisher Scientific has extensive history working with PAH clinical trial sites globally (more than 3,500 sites across 53 countries in the past five years). From that experience, we offer seven key takeaways.

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Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. 1 Over a quarter of those were for basic research purposes, with most common areas focused on the immune system, the nervous system and oncology. In Britain, 2.88 2020 [cited 2023Feb24].

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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.

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Olympian Clinical Research

APRIL 17, 2020

Sleep deprivation can interfere with the brain’s ability to consolidate and retrieve information. If you are experiencing unusual or abnormal forgetfulness, you may qualify for a FREE memory screening at Olympian Clinical Research. appeared first on Olympian Clinical Research.

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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.

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Olympian Clinical Research

JUNE 25, 2020

Be sure to inform your loved one’s caregivers, support staff, or other visitors about what triggers your loved one’s agitation and the methods you’ve identified that best help to calm them. The post Identifying & Coping With Agitation In Alzheimer’s Dementia Patients appeared first on Olympian Clinical Research.

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PPD

AUGUST 16, 2023

However, as the world settles into its post-pandemic state and returns to pre-pandemic paradigms in many areas, the pharmaceutical industry remains dedicated to moving beyond traditional, centralized clinical trial constructs. Study sponsors need quality results as quickly as possible to maximize profit-generation opportunities in the market.

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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.

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