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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PPD

JANUARY 2, 2025

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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Collaborative Drug

JUNE 13, 2024

How Successful are AI-Discovered Drugs in Clinical Trials? Approval of New Alzheimer’s Drug? Can Weight Loss Drugs Reduce Hear Attacks?

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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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

OCTOBER 3, 2023

Physician blogs are a great way to get your physicians’ messages out to the public. Blog articles that include your physicians’ bylines and consumer-friendly, understandable language help position your team of physicians as thought-leaders in their fields of expertise.

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Antidote

AUGUST 30, 2023

At the outset, many people may experience apprehension when considering joining a clinical trial. In this blog, we’re examining why participating in a clinical trial can be a rewarding experience for patients, and provide guidance on how potential volunteers can discover relevant studies.

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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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Conversations in Drug Development Trends

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Previously, organizations had limited influence on the direction of basic research, clinical trial designs, and data ownership.

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Crucial Data Solutions

APRIL 10, 2025

Why Wearable Tech Is Changing Clinical Trials Wearable devices are doing more than counting stepstheyre redefining how clinical trials are. The post How Wearable Devices Improve Patient Engagement in Clinical Trials appeared first on Crucial Data Solutions.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. Below, we explore some of the key themes seen in the changes.

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Cytel

JUNE 18, 2024

External Control Arms (ECAs) provide comparative evidence when recruiting patients is difficult or unethical in randomized controlled trials. In a previous blog , our experts took a deep dive into the concept of ECAs, their acceptable use cases, and the current regulatory guidance.

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Codon

FEBRUARY 13, 2025

Traditionally, scientists discover enzymes in nature and adapt them through trial and error. He also writes on a blog focused on the intersection of biology and AI at owlposting.com. These molecular machines power various cellular processes, from converting sugar into energy to switching genes on and off.

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National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Advancing reduction of drug use as an endpoint in addiction treatment trials astewart Thu, 03/06/2025 - 09:59 Nora's Blog March 18, 2025 Image Getty Images/ SolStock This blog was also published in the American Society of Addiction Medicine (ASAM) Weekly on March 18, 2025.&

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The Premier Consulting Blog

JANUARY 14, 2025

In this blog, we outline how the OCE gets involved in product reviews and offer a high-level summary of the programs and resources available for guiding oncology product development. Determining a new products pathway The OCE does not receive regulatory applications directly from sponsors who are developing new cancer therapies.

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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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Crucial Data Solutions

APRIL 22, 2025

The Evolution of Remote Patient Monitoring in Clinical Trials Remote patient monitoring (RPM) has come a long way from the. The post The Future of Remote Patient Monitoring in Decentralized Clinical Trials appeared first on Crucial Data Solutions.

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Crucial Data Solutions

MARCH 17, 2025

What Are Wearables and How Are They Used in Clinical Trials? Wearable technology is transforming clinical trials by making it. The post The Future of Wearable Technology in Clinical Trials appeared first on Crucial Data Solutions.

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H1 Blog

DECEMBER 4, 2023

As the pharmaceutical and biotech industries continue to push for faster drug development, the importance of equity and diversity in clinical trial recruitment cannot be overlooked. Data is a powerful tool in identifying and reaching vulnerable populations for clinical trials.

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Crucial Data Solutions

MARCH 20, 2025

What Is BYOD in Clinical Trials? Bring Your Own Device (BYOD) is changing the way clinical trials collect and manage. The post Bring Your Own Device (BYOD) Clinical Trials: How They Transform Decentralized Data Capture appeared first on Crucial Data Solutions.

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New Drug Approvals

JULY 7, 2025

1] Pimicotinib is under investigation in clinical trial NCT05804045 (Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)). 5] Following with pimicotinib for tenosynovial giant cell tumor treatment in phase III, pimicotinib has also entered into a phase II trial in June 2023 for cGVHD treatment in China. [6]

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Alta Sciences

JANUARY 15, 2024

How Is Your CRO Handling Your Trial Data? Check out these insightful resources: • The Altascientist— CDISC Data Standards • Fact Sheet— Comprehensive Research Support • Blog— Data Management Excellence Image Social_media_e_bulletin_The_Altascientist_issue_29_Data_Journey.png Tags About Altasciences Weight 1

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FDA Law Blog: Drug Discovery

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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The Premier Consulting Blog

OCTOBER 21, 2024

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

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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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FDA Law Blog: Biosimilars

FEBRUARY 27, 2025

As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.

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Crucial Data Solutions

DECEMBER 12, 2023

Decentralized clinical trials (DCTs) are growing. The post Decentralized Clinical Trials in 2024: A Look Ahead appeared first on Crucial Data Solutions. We may not be seeing the deep and widespread adoption of decentralized approaches some.

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Crucial Data Solutions

DECEMBER 19, 2023

The growth of decentralized clinical trial (DCT) strategies may be happening slower than many expected, but it is definitely happening. The post The Advantages of Decentralized Clinical Trials in Diabetes Research appeared first on Crucial Data Solutions.

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Clinical Trials Trials Research 59

Quanticate

OCTOBER 22, 2024

A blog article by a member of Quanticate's Clinical Programming team exploring SAS Proc Transpose VS SAS Arrays within Clinical Programming

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Clinical Trials Trials 52

The Premier Consulting Blog

DECEMBER 10, 2024

In this blog, we demystify the CMC section of NDA preparation , providing insights and guidance for navigating this intricate landscape. By the time of NDA submission, a sponsor should be able to demonstrate that the clinical materials used in pivotal trials are representative of the proposed commercial processes and product.

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FDA Law Blog: Drug Discovery

JANUARY 12, 2025

Despite including guidance on confirmatory trials and FDAs authority to require them, the Agency decided to publish an additional guidance focused solely on how it is interpreting the authority to require that such trials be underway prior to accelerated approval or within a specified time period after the date of accelerated approval.

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H1 Blog

MAY 18, 2023

Streamline your operations and improve trial feasibility and outcomes. Clinical Research Organizations (CROs) play an important role in the success of clinical trials. They provide crucial resources, processes, and strategies to ensure that trials are conducted with the highest standards of accuracy and data quality.

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Clinical Trials Trials Clinical Research Research 52

Advarra

OCTOBER 19, 2023

The clinical trial startup process has seen significant shifts over the past five years: growth in decentralized trials, improved technology, and an increased demand for accelerated timelines in getting therapies to market. This blog uncovers key findings from survey respondents.

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Clinical Trials Trials Clinical Research Research 52

H1 Blog

APRIL 2, 2025

Leveraging Data for More Inclusive Research Clinical trial representation is more than just a regulatory requirementits a critical component of accessible healthcare. Ensuring that trial participants reflect the real-world patient population leads to more effective treatments and better health outcomes.

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H1 Blog

JUNE 7, 2023

Clinical trial success is a key factor for pharma companies when designing and recruiting patients into trials. This data can also provide guidance in terms of diversifying clinical trials to include different types of population demographics such as age, gender, race, ethnicity, or geographic location.

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Crucial Data Solutions

JULY 7, 2025

The post How to Improve Patient Outcomes Using eSource Software in Clinical Trials appeared first on Crucial Data Solutions. In the modern clinical research environment, improving patient outcomes is both a regulatory imperative and an ethical priority.

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Crucial Data Solutions

MARCH 4, 2024

Clinical trial data is coming from more places than ever. The post How Can Real-world Data Benefit Your Trials? It can be collected directly from patients via native and. appeared first on Crucial Data Solutions.

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