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

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

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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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

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.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

New Drug Approvals

APRIL 11, 2025

1] [2] Adverse effects The US Food and Drug Administration prescription label for fitusiran contains a boxed warning for thrombotic events (blood clotting) and gallbladder disease (with some recipients requiring gallbladder removal). [2] Fitusiran 1711.0g/mol, 1] It is an antithrombin-directed small interfering ribonucleic acid. [1]

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Clinical Trials FDA FDA Approval Trials 107

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

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

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 Drug Development Therapies 69

Broad Institute

NOVEMBER 25, 2024

As a proof of concept, a drug designed to target a newly discovered biological node is showing efficacy in treating rare genetic diseases in the kidney, the eye, and the brain and is now making its way to clinical trials in collaboration with a pharmaceutical partner. We will keep you in the loop on upcoming events and research highlights.

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Clinical Trials Disease Trials Therapies 52

PPD

FEBRUARY 10, 2025

Todays clinical trials rely on technologically sophisticated systems that require complex integrations to capture and process all manner of data across multiple sites, often spread throughout multiple countries or jurisdictions. Electronic medical records (EMRs), for example, exemplify the evolving role of technology in clinical trials.

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Clinical Trials Trials Clinical Research Research 52

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 Drugs FDA Research 52

FDA Law Blog: Biosimilars

APRIL 13, 2025

The Untitled Letter notes that the confirmatory trial for LYTGOBI is currently ongoing and has not been completed; therefore, clinical benefit of LYTGOBI has not yet been confirmed. As a single-arm trial (i.e., The Untitled Letter states that a randomized controlled trial would be needed to assess delay in time to disease progression.

Drugs 52

Drugs FDA Trials Treatment 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

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

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

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

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

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

Collaborative Drug

OCTOBER 7, 2024

Learn more about chemical registration and the other benefits of CDD Vault and get your free trial. By registering new compounds, you make them available throughout CDD Vault for mining and analysis of screening results, for Structure Activity Relationship (SAR) studies, and for sharing with collaborators.

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Drugs Engineering Trials 262

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

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

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

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

Fierce BioTech

MAY 6, 2025

They will share lessons learned and concrete opportunities to transform clinical trial design, execution and outcomes. Key success factors for integrating biomarkers into clinical trials. Gain insights to de-risk and accelerate your trials. Learn from a real case of drug repositioning.

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Clinical Trials Trials Pharmaceuticals Disease 52

DrugBank

OCTOBER 17, 2024

By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.

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Drug Development Metabolic Stability Clinical Trials Drugs 98

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).

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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.

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Clinical Trials Trials FDA Therapies 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. You can access the conference brochure and sign up for the event here. And it is exactly that! As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25.

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FDA Clinical Trials Regulations Production 59

Collaborative Drug

OCTOBER 7, 2024

Learn more about the benefits of CDD Vault and get your free trial: This innovative hosted solution makes it possible to share selected data sets with your colleagues in the lab or across the globe.

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FDA Approval Laboratories FDA Research 264

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

JANUARY 17, 2025

WebinarAddressing Diversity in Early-Phase Clinical Trials lperez Fri, 01/17/2025 - 22:59 Image Website_Webinar_Clinical Diversity.jpg Tags Clinical Trials URL [link] Event End Date Fri, 03/28/2025 - 12:00 Event Start Date Fri, 03/28/2025 - 12:00 Weight 1

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Clinical Trials Trials 40

PPD

SEPTEMBER 16, 2024

This can be converted to a clinical trial simulator, which can model a clinical trial before the trial design is finalized and initiated. AI approaches are optimizing trial designs With a significant increase in the number of regulatory submissions to the U.S.

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Clinical Development Clinical Trials Clinical Research Trials 98