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 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

Fierce BioTech

OCTOBER 15, 2024

Is That Heart Attack Really an Adverse Event? The success of your highly complex clinical trial depends on accurate, reliable assessments of your endpoints. Learn how to accurately identify and attribute adverse events, eliminate conflicts of interest, and ensure the integrity of your studies.

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Clinical Trials Trials 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

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.

Disease 124

Disease Clinical Trials Trials Drugs 124

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

Advarra

FEBRUARY 22, 2024

Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as safe as possible and the participants have the most up to date information so they can decide whether to continue their participation in the research study. Who Should Assess AEs in Clinical Trials? regulations.

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Clinical Trials FDA Drugs Research 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

PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders. This is where contact center services play a vital role.

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Clinical Trials Trials Compliance Clinical Research 52

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 63

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

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.

Clinical Trials 52

Clinical Trials Trials Research 52

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

Fierce BioTech

SEPTEMBER 20, 2023

In this podcast interview, Dan Fisher, managing director and practice lead for IPM.ai, explains the use of artificial intelligence for stitching together key medical events that may happen over a r | IPM.ai helps brands assess a unique patient population, accelerate clinical trial recruitment, and optimize commercial outcomes

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Clinical Trials Disease Trials 105

Conversations in Drug Development Trends

AUGUST 10, 2023

Sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), the event was the largest psychedelics conference in history, bringing in approximately 12,000 participants and 300+ speakers from around the world. Check out our full psychedelics offering, and meet the team responsible for planning your clinical trial.

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Science Clinical Trials Trials Clinical Research 98

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.

Clinical Trials 52

Clinical Trials Trials Clinical Research Treatment 52

PPD

JULY 29, 2024

AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials. A high-risk participant can be even excluded from the study based on the severity of the adverse event.

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Clinical Research Clinical Trials Research Trials 98

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.

Clinical Trials 52

Clinical Trials Trials 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.

Clinical Trials 52

Clinical Trials Trials Hospitals Drugs 52

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

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

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

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).

Clinical Trials 52

Clinical Trials Trials Compliance Laboratories 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

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.

Clinical Trials 52

Clinical Trials Trials FDA Therapies 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

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

Drug Target Review

JULY 4, 2023

2 However, when dosed at the MTD, ADCs display improved efficacy over small molecules in oncology trials. Whilst no trials have been performed directly comparing small molecules with their ADC counterparts, it is possible to contrast data from trials with ADCs to those performed with analogous small molecules.

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Small Molecule Drugs Clinical Pharmacology Trials 145

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

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.

Clinical Trials 52

Clinical Trials Trials Compliance Regulations 52

Advarra

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinical trial’s safety and efficacy.

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Clinical Trials Trials International Clinical Research 97

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

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

LifeSciVC

JANUARY 16, 2024

Still may be some merit if they are clinical-stage and can achieve once-daily dosing without too steep a cut in efficacy or worsened adverse events vs. peptides, but be wary of the intensely competitive landscape. Additional trials (e.g., A permanent gene edit to produce a difficult-to-titrate supply of GLP1 in the liver?

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Small Molecule Trials Therapies Disease 137

The Pharma Data

APRIL 28, 2022

Novo Nordisk today announced headline results from the ONWARDS 2 trial, a phase 3a, 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec in 526 people with type 2 diabetes switching from daily insulin. events per patient year exposed to once-weekly insulin icodec and 0.27

Trials 52

Trials Clinical Trials Treatment Clinical Development 52

The Pharma Data

MAY 30, 2023

Pfizer Announces Positive Marstacimab Results from Pivotal Phase 3 Hemophilia A and B Trial (NYSE: PFE) today announced that the pivotal Phase 3 BASIS clinical trial ( NCT03938792 ) evaluating marstacimab has met its primary endpoints, having demonstrated statically significant and clinically meaningful effects.

Trials 52

Trials Clinical Trials Treatment Therapies 52

Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

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Vaccine Trials Disease Treatment 110