ProRelix Research

FEBRUARY 12, 2023

Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused […] The post Clinical Trial Regulations in the United States appeared first on ProRelix Research.

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Clinical Trials Regulations Trials Research 105

PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

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Clinical Trials Trials Compliance International 98

PPD

AUGUST 28, 2024

For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.

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Trials Clinical Trials Therapies Drug Development 64

Conversations in Drug Development Trends

AUGUST 29, 2024

By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.

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Clinical Trials Trials Disease Drug Development 52

PPD

AUGUST 5, 2024

Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success. Their early definition — as well as plans for recording and tracking — is a major factor in a trial’s success.

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Clinical Trials Trials Clinical Research Disease 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.

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Clinical Trials Trials Clinical Research Disease 52

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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Clinical Trials Trials FDA Regulations 105

Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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Clinical Trials Trials Compliance Laboratories 52

Quanticate

MARCH 11, 2024

Clinical trials although methodically planned, can hit unexpected roadblocks steering them off course. From resource shortages and unforeseen service needs to contractual issues, recruitment problems and adverse events, these challenges can bring even the most carefully planned trials to a grinding halt.

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Clinical Trials Trials Research 52

Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

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Clinical Trials Trials Clinical Research Treatment 52

Alta Sciences

MAY 10, 2024

Outsourcing in Clinical Trials Southern California iianiro Fri, 05/10/2024 - 19:02 Image pic.jpg Synopsis San Diego, CA Tags Clinical Trials URL [link] Event End Date Wed, 09/25/2024 - 12:00 Event Start Date Tue, 09/24/2024 - 12:00 Weight 1

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Clinical Trials Trials 40

Antidote

JUNE 27, 2024

In case you missed it, we’re sharing some of our key takeaways from the four-day event, which focused on charting new horizons in clinical trials. Not only was it a lovely opportunity to connect with many industry professionals and learn from experts, but it was also the celebration of 60 years of DIA.

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Clinical Trials Trials 52

Antidote

NOVEMBER 13, 2023

Each November is designated as Diabetes Awareness Month , an event that highlights the importance of spreading awareness about diabetes and the health issues it can cause.

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Clinical Trials Trials 122

Conversations in Drug Development Trends

JULY 8, 2024

By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. Treatment Treatment can take various forms, including therapy, medication, a combination of both, or a clinical trial.

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Clinical Trials Trials Treatment Therapies 52

FDA Law Blog: Drug Discovery

SEPTEMBER 28, 2023

Hear about the new requirements under FDORA related to increasing diversity in clinical trials, strategies for increasing the participation of subjects from historically underrepresented groups, and how these new requirements and approaches should be considered in clinical trial and other related agreements.

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Clinical Trials Trials Hospitals Drugs 52

The Pharma Data

OCTOBER 15, 2020

More than a month has passed since AstraZeneca’s phase 3 COVID-19 vaccine trial was paused due to a potential adverse event, but few solid details have emerged from ongoing safety reviews by the FDA and the UK drugmaker. The vaccine trial, which has resumed in other countries but remains halted in the U.S., James Miessler.

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Vaccine Trials FDA Licensing 52

Alta Sciences

DECEMBER 27, 2023

Outsourcing in Clinical Trials West Coast iianiro Wed, 12/27/2023 - 19:02 Image images.jpg Synopsis Burlingame, CA URL [link] Event End Date Wed, 02/07/2024 - 12:00 Event Start Date Tue, 02/06/2024 - 12:00 Weight 1

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Clinical Trials Trials 40

Alta Sciences

DECEMBER 27, 2023

Outsourcing in Clinical Trials New England iianiro Wed, 12/27/2023 - 21:45 Image boston-massachusetts-BOSTONTG0221-719aef2eeb1c4929b6c839715e34a69e.jpg Synopsis Boston, MA URL [link] Event End Date Thu, 10/24/2024 - 12:00 Event Start Date Wed, 10/23/2024 - 12:00 Weight 1

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Clinical Trials Trials 40

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. There’s little time to lose.

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Clinical Trials Trials Clinical Research Doctors 86

Alta Sciences

DECEMBER 27, 2023

13th Annual Outsourcing in Clinical Trials Southeast iianiro Wed, 12/27/2023 - 19:10 Image GI_473777570_RaleighNC_Landscape.jpg Synopsis Durham/Raleigh Research Triangle, NC URL [link] Event End Date Wed, 04/17/2024 - 12:00 Event Start Date Tue, 04/16/2024 - 12:00 Weight 1

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Clinical Trials Trials Research 40

FDA Law Blog: Drug Discovery

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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Clinical Trials Trials FDA Production 59

The Pharma Data

NOVEMBER 8, 2021

Bristol Myers Squibb moment blazoned the Phase 3 CheckMate-816 trial met the primary endpoint of bettered event-free survival (EFS) in cases with resectable stage IB to IIIAnon-small cell lung cancer (NSCLC). Bristol Myers Squibb thanks the cases and investigators who were involved in the CheckMate-816 clinical trial.

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Trials Clinical Trials Treatment Clinical Development 52

On Medicine

SEPTEMBER 12, 2023

Considering such findings, the United Nations Office on Drugs and Crime (UNODC) combined the TRT intervention with parenting strategies designed to enhance the carer’s capacity to support children through life events such as disasters, conflicts, and displacement. TRT + Parenting was trialled in Lebanon with Syrian families.

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Trials Treatment Research Clinical Trials 107

The Pharma Data

MARCH 30, 2021

today announced that the company will host a virtual Investor Event on Friday, April 23, 2021 at 10:30 a.m. Investors and the general public are invited to listen to a live webcast of the event at [link]. Materials related to the webcast will be available at the same website prior to the event. Source link:[link].

Trials 52

Trials 52

Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. As clinical trial design becomes more dynamic and adaptive, studies require more complex statistics and more specialized biostatisticians to ensure study data are relevant and scientifically valid.

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Trials Clinical Trials FDA Approval Therapies 52

Advarra

JANUARY 13, 2023

Endpoint adjudication committees (EACs), also called clinical event committees (CECs), receive potentially identifiable research data from all over the world. This blog explores what it takes for an EAC/CEC to adequately support worldwide clinical trials. The Global Reach of EACs and CECs.

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Clinical Trials Regulations Trials International 52

Advarra

FEBRUARY 24, 2023

But what does “working” really mean when efficacy means something subjective, like quality of life, reduced psychiatric events, or less symptoms? In most cases, the results you are really looking for and trying to prove in a trial can be complex. All key questions to consider and address before the therapy even leaves the lab.

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Clinical Trials Trials FDA Therapies 52

Vial

FEBRUARY 21, 2024

Clinical trials are needed to determine whether a medical device can produce sufficient proof of its efficacy. However, medical device sponsors and developers are limited by the complex regulatory processes and the high costs associated with the design of running clinical trials for their products.

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Clinical Trials Trials Compliance Regulations 52

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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Clinical Trials Trials Compliance FDA 40

Drugs.com

MAY 24, 2024

FRIDAY, May 24, 2024 -- Ozempic provides a wide variety of health benefits for people with kidney disease and type 2 diabetes, a major clinical trial has found. The drug significantly reduces the risk of severe kidney events, heart problems and.

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Disease Clinical Trials Trials Drugs 124

Alta Sciences

FEBRUARY 12, 2024

Webinar—CNS-Active Compounds: The importance of Cognitive and Pharmacodynamic Testing During First-In-Human Trials iianiro Mon, 02/12/2024 - 22:26 Image Website_Webinar_CNS-Active Compounds_v2.jpg jpg URL [link] Event End Date Thu, 04/25/2024 - 12:00 Event Start Date Thu, 04/25/2024 - 12:00 Weight 1

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Trials 40

The Pharma Data

SEPTEMBER 1, 2020

Explore how emerging trends in clinical trial investigations are bringing patients closer to medicine making them more patient-centric. The patient experience is an important consideration in trial design. Download your copy today to find out how to digitally transform your clinical trials. Download Your Copy.

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Clinical Trials Trials Regulations Production 52

SCIENMAG: Medicine & Health

FEBRUARY 26, 2024

The 7th World Conference on Targeting Phage Therapy 2024, two-day event dedicated to advancing the field of phage research and therapy will be hosted at Corinthia Palace Malta on June 20-21.

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Therapies Clinical Trials Research Trials 89

Crucial Data Solutions

MAY 31, 2023

Clinical trials continue to move closer to patients. Many patients, now, can participate fully in clinical trials largely from home by utilizing remote data collection technologies such as ePRO, eConsent, virtual visits, and more. They do so, largely, from mobile devices – often their very own smartphones.

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Clinical Trials Trials Compliance Research 52

Vial

DECEMBER 5, 2023

Among others, NGS has led to the identification of disease-causing variants and novel drug targets and an improved understanding of complex biological events, e.g., the heterogeneity of tumors. It has become a fundamental tool for researchers to explore the complexities of genetic information and conduct genetic-informed drug development.

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Clinical Trials Trials RNA Bioinformatics 52

Advarra

JUNE 13, 2024

Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their use is becoming increasingly common in clinical trials. For example, a site conducting only protocols involving mRNA may be able to leverage a generic SOP covering any mRNA protocol at that site.

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Clinical Trials Engineering Trials Virus 52

Drug Channels

JULY 19, 2021

Finance and Accounting for Bioscience Companies – Hybrid Events. Tailored to the unique nuisances of bioscience companies, these CPE-accredited annual events bring together the brightest financial and accounting minds from the nation’s leading trailblazers. www.informaconnect.com/financeaccountingeast. Earn up to 16.3 CPE credits.

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Clinical Trials Science Marketing Trials 40