Article, Clinical Development and Clinical Research

The rising impact of biomarkers in early clinical development

Drug Target Review

APRIL 7, 2025

As biomarkers become increasingly relevant in indicating the workings and effects of novel therapies, their potential as valuable clinical and regulatory endpoints is also gaining recognition. Biomarkers can play a crucial role throughout clinical development, especially in early phases.

Clinical Development

Clinical Development Clinical Trials Clinical Pharmacology Trials

Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence

PPD

MARCH 11, 2025

Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development. Identifying the right target patient profiles becomes even more difficult when there is no clear consensus on how disease progression manifests across different individuals.

Drug Development

Drug Development Clinical Trials Disease Trials

What Successfully Recruited Post-COVID Oncology Trials Have in Common

Conversations in Drug Development Trends

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

Trials

Trials Clinical Trials Clinical Development Clinical Research

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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To Share or Not to Share Failed Genetic Screening Results with Patients

Conversations in Drug Development Trends

FEBRUARY 6, 2023

For a deep look into the best practices and considerations for including genetic testing in your clinical development strategy, read this article by our Aman Khera, Vice President, Global Head of Regulatory Strategy and Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Diseases. Read the full article!

Clinical Trials

Clinical Trials Trials Disease Clinical Development

Topics in Bayesian Statistical Methods

Cytel

DECEMBER 16, 2022

Bayesian methods have been playing a key role in transforming clinical research, and Bayesian topics are frequently featured in Cytel’s Perspectives on Enquiry and Evidence. Our new ebook features a set of articles exploring various topics related to Bayesian statistical methods. Topics include:

Clinical Research

Clinical Research Research Clinical Trials Clinical Development

Women in STEM with Kristina Torfgard

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

Pharma Companies

Pharma Companies Licensing Licensing Disease

IQVIA vs Vial | Pros and Cons

Vial

APRIL 10, 2024

This article provides a comparative overview of Vial and IQVIA. The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. increase on a reported basis and an 4.8%

Clinical Trials

Clinical Trials Trials Clinical Research Compliance

[Webinar] How biotech companies can improve clinical supply planning and distrib…

The Pharma Data

SEPTEMBER 15, 2020

During her medical practice, Seredina worked in clinical research as an investigator. The results of her research were published in a number of articles highlighting her knowledge of the critical challenges of clinical sites and of the importance of being patient-centric. The webinar will take place at: .

Clinical Supply

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What is the largest CRO in the US?

Vial

MARCH 1, 2024

By type of service, clinical research services accounted for the lion’s share of the North American CRO services market, followed by early-phase development services, laboratory services, and consulting services. This acquisition has allowed the company to position itself as a global leader in clinical research services.

Clinical Trials

Clinical Trials Clinical Research Trials Laboratories

How Many Clinical Trials Are Run by CROs?

Vial

FEBRUARY 29, 2024

However, despite their increasingly ubiquitous role in the clinical research industry, the question remains as to the extent of their participation. That is, how many clinical trials are actually managed by these organizations? Understanding the Numbers: How Many Clinical Trials Utilize CROs?

Clinical Trials

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Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

Clinical Trials

Clinical Trials Trials Treatment Disease

Article FDA Thank You New regulatory ‘playbook’ from FDA-supported Bespoke Gene Therapy Consortium aims to accelerate development

Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

FDA

FDA Therapies Clinical Trials Disease

New targeted therapies show promise in lung cancer treatment

Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. Antibody-drug conjugates treatment of small cell lung cancer: advances in clinical research. Curr Probl Cancer. 2024;49:101075. Discov Oncol.

Therapies

Therapies Treatment Clinical Trials Drugs

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA

FDA Production Regulations Vaccine

Worldwide Clinical Trials vs Vial | Pros and Cons

Vial

MARCH 25, 2024

With neuroscience experience in Alzheimer’s Disease (AD) and dementia, neurology , pain and addiction, rare and other diseases, and psychiatry, Worldwide has been involved in neuroscience research since the 1970s. Vial’s scientific advisory board has experience across all its therapeutic areas and immuno-oncology for the Oncology CRO.

Clinical Trials

Clinical Trials Trials Clinical Development Clinical Research

The Costs of Working with a CRO

Vial

MARCH 27, 2024

In this article, we delve into the factors influencing costs of working with a CRO, expenses associated with clinical trials, and whether CROs are more cost-effective than sponsors acquiring support themselves. However, this will depend heavily on the specific circumstances of the trial.

Clinical Trials

Clinical Trials Trials International Compliance

Can Your CRO Add Value During a Recession?

PPD

JUNE 20, 2023

As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. Does your CRO look after your most valuable resources?

Clinical Trials

Clinical Trials Drug Development Trials Clinical Research

Syneos vs Vial | Pros and Cons

Vial

APRIL 24, 2024

The Vial Dermatology CRO Phase I unit provides a unified full-service solution to early clinical development. Technology and Tools To remain relevant and offer clients a full range of value-added solutions, small CROs like Vial keep current on the latest technologies, techniques, and tools in clinical research.

Clinical Trials

Clinical Trials Trials Biosimilars Disease

Tiziana Life Sciences announces collaboration with Parexel Biotech to conduct phase 1b/2 clinical trial in patients with Crohn’s Disease

The Pharma Data

NOVEMBER 10, 2020

We believe switching to oral, nasal and inhalational administration of mAbs from the traditional intravenous administration could potentially be transformational for the future development of immunotherapies.”. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

Clinical Trials

Clinical Trials Science Disease Trials

Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.]

Science

Science FDA Production Trials

Why DNA Damage Response deserves renewed focus in cancer therapy

Drug Target Review

MARCH 25, 2025

With extensive experience in developing novel therapeutics, spanning discovery to clinical trials, he oversees both preclinical and clinical pharmacology of assets from Phase I to III.

DNA

DNA Therapies Clinical Trials Clinical Pharmacology

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.] representative population.

FDA

FDA Science Clinical Trials Production

Drug Discovery Digest

The rising impact of biomarkers in early clinical development

Overcoming Orphan Drug Development Challenges with Real-World Data and Evidence

Webinars

Trending Sources

What Successfully Recruited Post-COVID Oncology Trials Have in Common

Webinars

To Share or Not to Share Failed Genetic Screening Results with Patients

Topics in Bayesian Statistical Methods

Top Bayesian Topics of 2022

Women in STEM with Kristina Torfgard

IQVIA vs Vial | Pros and Cons

[Webinar] How biotech companies can improve clinical supply planning and distrib…

What is the largest CRO in the US?

How Many Clinical Trials Are Run by CROs?

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Article FDA Thank You New regulatory ‘playbook’ from FDA-supported Bespoke Gene Therapy Consortium aims to accelerate development

New targeted therapies show promise in lung cancer treatment

Article FDA Thank You FDA updates set the stage for broader use of harmonized standards for safety reporting

Worldwide Clinical Trials vs Vial | Pros and Cons

The Costs of Working with a CRO

Can Your CRO Add Value During a Recession?

Syneos vs Vial | Pros and Cons

Tiziana Life Sciences announces collaboration with Parexel Biotech to conduct phase 1b/2 clinical trial in patients with Crohn’s Disease

Analysis Life Sciences Thank You FDA’s Diversity Action Plan: Questions, answers, and what we (don’t) know so far

Why DNA Damage Response deserves renewed focus in cancer therapy

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

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