Crucial Data Solutions

OCTOBER 21, 2024

Artificial intelligence (AI) is transforming the clinical research landscape. The post From Study Design to Submission: The Role of AI Throughout the Clinical Research Journey appeared first on Crucial Data Solutions. It is being used to optimize how data is collected, organized.

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Crucial Data Solutions

JULY 23, 2024

It is not hyperbole to say that data is transforming clinical research at a breakneck pace. The post Don’t Drown in Data – Clinical Research Data Management Can be Easy, with a Little REST appeared first on Crucial Data Solutions. The critical need to.

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Clinical Research Research 59

Crucial Data Solutions

DECEMBER 1, 2023

The clinical research industry is currently dealing with a great deal of uncertainty, with various solutions providers announcing layoffs often. The post In a Time of Uncertainty for Clinical Researchers, Reliable Partners are Vital appeared first on Crucial Data Solutions.

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Clinical Research Research 59

PPD

JANUARY 2, 2025

This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs. FSP outsourcing is growing faster than FSO.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Crucial Data Solutions

OCTOBER 25, 2024

In clinical research, the advent of artificial intelligence (AI) is transforming the way study teams approach their work. The post The Digital Teammate: How AI is Changing How Clinical Research Teams Work appeared first on Crucial Data Solutions.

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Clinical Research Research 52

FDA Law Blog: Biosimilars

MARCH 29, 2024

Many have noted that FDA has been slow to recover We’ve blogged before on FDA’s post-pandemic inspection work, writing about the resumption of both good manufacturing practice (GMP) and bioresearch monitoring (BIMO) inspections. In other words, the inspectional output was inversely proportional to the importance of clinical research.

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National Drug & Alcohol Research Centre Blog

JULY 13, 2021

NCCRED was funded through the Strategy, and commenced in 2018, to build clinical research capacity and work towards establishing evidence-based treatment approaches for both methamphetamines and other emerging drugs of concern. Why do a clinical research priority setting study?

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Clinical Research Research Clinical Trials Trials 52

thought leadership

JULY 17, 2023

Decentralized clinical trials (DCTs) have emerged as a transformative approach in clinical research, offering unique benefits that challenge the traditional models. In this blog post, we will delve into the decision-making process of whether to embrace DCTs or stick with conventional trials.

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Quanticate

MAY 21, 2020

This blog focuses on regulatory writing, which involves the preparation of clinical study and regulatory submission documentation. There are two main areas in medical writing, medical communications and regulatory writing.

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Clinical Research Research Clinical Trials FDA 52

Advarra

MARCH 14, 2023

Maintaining regulatory compliance at research sites and institutions is no small feat – documents need to be updated and maintained in a consistent manner to ensure compliance. Advarra’s eRegulatory Management System (eReg) is designed to adapt to and streamline research site regulatory workflows.

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Clinical Research Research Compliance Clinical Trials 52

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.

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S. The seven awardees included six early-stage trials (e.g.,

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Alta Sciences

JUNE 26, 2025

AI Innovations in Ophthalmic Research ARVO is one of the largest global conferences for ophthalmology research , attracting nearly 11,000 attendees from over 60 countries. Hosted by the Association for Research in Vision and Ophthalmology, it serves as a platform for exchanging cutting-edge research findings.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Implications for Future of Clinical Research R3 represents an important evolution in GCP, shifting away from a prescriptive model toward a more flexible, risk-based approach.

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Clinical Trials Trials Clinical Research Government 88

Alta Sciences

JANUARY 31, 2025

Guest Blog: Reflecting on the 2024 Society of Toxicology of Canada Symposium, by Ria Falvo, Director, Reporting pmjackson Fri, 01/31/2025 - 15:47 Ria Falvo, Director of Reporting, and Rina Massarelli, Associate Director of Safety Reporting, in Toronto, Ontario, for the 2024 STC Symposium. Tags Preclinical Research Weight 15

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Crucial Data Solutions

JULY 31, 2024

In our last blog, we brought up the topic of vaporware in clinical research data management. Clinical trials require a. The post Avoiding Clinical Data Vaporware – Even More Questions to Ask eClinical Platform Providers appeared first on Crucial Data Solutions.

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Clinical Trials Clinical Research Trials Research 59

Advarra

AUGUST 8, 2023

Gene therapy research is booming in the clinical setting. In this blog, we summarize the growth, risks, and regulatory requirements for gene therapy research. We also discuss how a centralized biosafety review process can benefit this type of research.

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Advarra

JULY 18, 2022

To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. What Systems Integrate with an eTMF?

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Research Clinical Trials Compliance Regulations 52

Advarra

JULY 3, 2025

10 areas that may impact your organization The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Staff training & protocol compliance: Are your protocols and procedures being updated to incorporate these core tenets of R3?

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Advarra

SEPTEMBER 27, 2023

If there’s one constant in clinical research, it’s change. With continual innovations and transformations, establishing a human research protection program (HRPP) can help many research institutions adapt to these changes while upholding the highest ethical standards.

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Advarra

DECEMBER 12, 2023

The clinical research industry, like many others, has continued to be challenged by staff turnover in recent years. Clinical research organizations everywhere are seeing an influx of employees leaving their positions to go elsewhere. Understanding this issue is essential to a healthy research organization.

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Molecule Blog

MARCH 17, 2023

Moving research from concept to market is like conducting a symphony — there are numerous players and stakeholders, each bringing their unique expertise to work in harmony and advance a project. BioDAOs fund and incubate projects during the initial stages of translational research, often through IP-NFTs, even before a company is established.

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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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Advarra

MAY 14, 2025

With a decade of experience as regulatory counsel in the FDAs Center for Drug Evaluation and Research Office of Scientific Investigations, her experience will help Advarras clients and internal teams navigate the ever-shifting regulatory landscape for human subjects research. Sponsors often ask, How will the FDA view this?

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thought leadership

JULY 10, 2023

These innovative approaches leverage technology and local clinicians to bring clinical research directly to patients, shifting away from the traditional, site-centric model.

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Clinical Trials Trials Clinical Research Research 40

Crucial Data Solutions

JULY 7, 2025

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

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Clinical Trials Trials Clinical Research Research 52

NIH Director's Blog: Drug Development

OCTOBER 11, 2022

Through the years, NIH has supported a total of 169 researchers who have received or shared 101 Nobel Prizes. This form of chemistry has made it possible for researchers to snap together, like LEGO pieces, molecular building blocks to form hybrid biomolecules, often with easy-to-track imaging agents attached.

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Olympian Clinical Research

AUGUST 27, 2018

Through their participation in clinical research studies, they have given an extraordinary gift of hope to future generations! Choosing to participate in a research study is a very personal decision. However, when study volunteers participate in research, society benefits! Medical heroes are all around us.

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Clinical Trials Trials Clinical Research Pharmacy 40

Advarra

NOVEMBER 17, 2022

But for the nusinersen clinical trials, children were most likely to benefit, and so the clinical trials began without first collecting data on adult research participants. Even though this was a big step for involving children in clinical trials, kids haven’t always been as fortunate. Why This Guidance Now?

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H1 Blog

DECEMBER 4, 2023

In this blog post, we will explore 5 essential questions that clinical trial operations leadership and feasibility teams must consider in order to achieve true equity and parity in recruitment. This not only increases diversity in clinical trials but also ensures that all segments of the population are represented in drug development.

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Crucial Data Solutions

MAY 2, 2024

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

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Clinical Trials Trials Clinical Research Research 59

Crucial Data Solutions

DECEMBER 21, 2023

Over the past year, all of us working in clinical research have seen a significant increase in the number of. The post The Year Ahead: What Does EDC Look Like In 2024 and Beyond? appeared first on Crucial Data Solutions.

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Clinical Research Research 59

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. Each of these have contributed to a rapidly evolving clinical research landscape.

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Clinical Trials Trials Clinical Research Research 52

Alta Sciences

OCTOBER 15, 2024

He was promoted to Associate Director, Program Management , in 2022, and now oversees a team of program managers who guide end-to-end solutions, including preclinical , clinical , CDMO , regulatory , and bioanalytical solutions. Image blog-thumbnail-up-close-jason_1.jpg What Was your dream job as a child? jpg Weight 1

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Pharmacokinetics Drug Development Clinical Trials Science 52

Advarra

JANUARY 10, 2023

As the clinical research industry becomes more centered on technology, perhaps one of its most underused solutions is the electronic consent (eConsent) platform. This blog outlines why adopting an eConsent platform is a beneficial and strategic step sites can take right now. eConsent Gives Sites Flexibility.

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Clinical Trials Clinical Research Trials Research 52

New Drug Approvals

JULY 8, 2025

Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Research and Development: Pritelivir is being developed by AiCuris Anti-infective Cures, building upon research from Bayer. amcrasto@gmail.com NEW DRUG APPROVALS ONE TIME $10.00

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