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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Clinical Trials Drugs Trials 272

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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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

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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Doctors Clinical Trials Marketing Engineering 52

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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Research Clinical Trials Trials Treatment 119

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

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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Trials Treatment Clinical Development 59

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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Clinical Trials Trials 59

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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Treatment Trials Clinical Trials Drugs 69

FDA Law Blog: Drug Discovery

MARCH 13, 2023

Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision about whether to participate in a clinical trial, and what kind of treatment effects would be most meaningful to them?

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Therapies Trials FDA Clinical Trials 98

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

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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Small Molecule Engineering Production DNA 124

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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Clinical Trials Trials Pharmaceutical Companies Drug Development 59

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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Trials Clinical Trials Drug Development Research 52

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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FDA Disease Clinical Pharmacology Science 105

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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Trials FDA Clinical Trials Disease 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

Crucial Data Solutions

MAY 2, 2024

The post Wearables in Clinical Trials: Real Benefits Beyond the Hype appeared first on Crucial Data Solutions. In clinical research, innovations in technology are moving us down an exciting path, transforming traditional methodologies and paving the way.

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Clinical Trials Trials Clinical Research Research 59

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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FDA Clinical Trials Regulations Production 59

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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Clinical Trials Trials 59

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

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

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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Trials Clinical Trials Pharma Companies Clinical Development 52

Conversations in Drug Development Trends

MAY 23, 2024

By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.

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Trials Clinical Trials Therapies Treatment 52

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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Trials Clinical Trials 59

PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). In this blog, our PPD FSP regulatory affairs solutions experts share lessons learned, along with tips for success.

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Clinical Trials Trials Regulations Pharmaceutical Companies 52

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

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

Alta Sciences

FEBRUARY 8, 2024

Altasciences’ ability to design and conduct specialized tests, combined with our partnership with CRC, allows us to seamlessly incorporate driving simulation elements into your clinical trials. Tags Clinical Trials Weight 12 View the Driving Simulation Fact Sheet for more information.

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Clinical Trials Trials Clinical Pharmacology Clinical Development 52

FDA Law Blog: Drug Discovery

OCTOBER 11, 2023

Snow — On September 18, 2023, FDA published an updated, final iteration of guidance for immediate implementation entitled, “ Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies.” hurricane) or public health emergency (e.g.,

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Clinical Trials Trials FDA Drug Development 64

H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When time is of the essence, like in a global pandemic, how do you scale trials internationally for success? Additionally, clinical trials are no longer confined to one country or region.

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Trials Clinical Trials International Regulations 59

Crucial Data Solutions

FEBRUARY 24, 2025

The Impact of Bias on Clinical Trials and Patient Safety Bias, despite best efforts and best intentions, continues to impact. The post How EDC Software Minimizes Bias in Clinical Trials appeared first on Crucial Data Solutions.

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Clinical Trials Trials 52

H1 Blog

APRIL 5, 2023

Data networks are valuable to inform clinical trials with insights and analyses such as patient population selection criteria, site selection criteria, site performance evaluation criteria, Principal Investigator (PI) selection criteria, and incorporating population health efforts into informing trial selection.

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Clinical Trials Trials Regulations Disease 52

Crucial Data Solutions

SEPTEMBER 27, 2024

Clinical trial delays cost everyone. The post The Benefits of Real-Time ePRO/eCOA in Clinical Trials: Stay Ahead with Instant Insights appeared first on Crucial Data Solutions. They cost sponsors in the traditional, dollars-and-cents way. However, they also cost patients and their.

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Clinical Trials Trials 59

PPD

SEPTEMBER 24, 2024

The enterprise of delivering life-changing medicines to patients involves a complex ecosystem, and in many ways, three key players reside at the core: drug sponsors, the contract research organizations (CROs) that support them and the clinical research sites directly engaging with patients in the trial. We can help. appeared first on PPD.

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Clinical Research Clinical Trials Trials Research 98

H1 Blog

JULY 19, 2023

Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics , regarding clinical trial design specific to oncology with considerations to support accelerated approval applications.

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Clinical Trials Trials FDA Treatment 52