Advarra

AUGUST 8, 2024

The EU AI Act’s implications extend into clinical research, where AI is increasingly utilized for tasks like medical image analysis, natural language process for endpoint analysis, and generating/analyzing data for synthetic control arms. Non-EU companies must comply with the AI Act if their AI systems are used in the EU market.

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Broad Institute

JANUARY 24, 2024

Terra is now generally available on Microsoft Azure By Allessandra DiCorato January 24, 2024 Breadcrumb Home Terra is now generally available on Microsoft Azure Terra on Microsoft Azure expands support for enterprises and data scientists across the globe. Compliance agreements: Terra can now sign HIPAA Business Associate Agreements for U.S.

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FDA Law Blog: Biosimilars

MARCH 29, 2024

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. between 2024 and 2030. billion in 2023 and is expected to grow at a CAGR of 7.0%

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Conversations in Drug Development Trends

JULY 9, 2024

Due to this meaningful change, the first-ever GLP-1-Based Therapeutics Summit took place in Philadelphia on May 15-16th, 2024, serving as a platform for industry decision-makers to provide invaluable insights for therapeutic strategies. Glucagon also spares the GLP-1 effects potentially reducing side effects leading to increased compliance.

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Vial

FEBRUARY 8, 2024

In recent years, however, clinical trials have become increasingly complex, adding burden to research teams and clinical research sites. Starting with describing challenges faced in managing clinical trials, we explore how CROs address challenges and how sponsors benefit from partnering with CROs. billion in 2030.

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Clinical Trials Trials Clinical Research Research 52

Vial

MARCH 27, 2024

According to a report by Grand View Research, the global CRO services market was valued at approximately US$50.55 from 2024 to 2030. Personnel salaries, site rentals, and equipment maintenance are other necessary expenses associated with clinical trials.

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Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding.

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Advarra

APRIL 25, 2024

The only constant in clinical research is change. Researchers are always innovating, making it a necessity to navigate complex organizational change. Technology continues to advance clinical operations, and organizations must proactively adapt. How can your organization stay on top of it all?

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Agency IQ

MAY 28, 2024

BY RACHEL COE, MSC | MAY 23, 2024 7:12 PM CDT Yesterday’s Energy & Commerce Health Subcommittee Hearing All three of FDA’s medical product center directors appeared before the Health Subcommittee of the U.S. “It’s

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Vial

MARCH 1, 2024

Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drug development and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards. billion by 2029.

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Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Agency IQ

JUNE 28, 2024

The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

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Agency IQ

APRIL 8, 2024

This week, the FDA announced it is finally ready to start accepting adverse event submissions in ICH E2B(R3) format and that the countdown to mandatory compliance with these requirements has begun. Starting just recently in mid-January 2024 , FDA began accepting post-marketing ICSRs in the E2B(R3)-format.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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PPD

NOVEMBER 8, 2022

PPD, Thermo Fisher Scientific’s clinical research business, surveyed more than 150 biotech and biopharma leaders this year to assess trends in the drug development industry, yielding data we’ll cite throughout this blog. In addition, adaptive trial designs will contribute to innovations in clinical research insights.

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PPD

NOVEMBER 4, 2024

The PPD clinical research business of Thermo Fisher Scientific has conducted a comprehensive survey involving 150 drug developers from around the world. This year’s findings reveal a nuanced landscape where rising clinical trial costs, complex protocol designs and patient recruitment issues have emerged as significant challenges.

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PPD

MAY 14, 2025

Though the market began to stabilize in 2024, recent changes in the economic, political and regulatory landscape are fueling uncertainty. In a 2024 survey of drug developers , they cite the rising cost of clinical trials and the lack of funding as the top two challenges they face, and for good reason.

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Perficient: Drug Development

JANUARY 24, 2025

Knowledge Management & Clinical Research The exponential growth of medical knowledge presents both challenges and opportunities for acute care providers. GenAI can serve as a powerful tool for knowledge management and clinical research, enabling healthcare organizations to stay at the forefront of evidence-based practices.

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PPD

JANUARY 21, 2025

In 2024, the U.S. This decrease brings into sharp focus the growing challenges facing the field: Clinical trials now demand greater complexity, as well as increased data and diversity requirements. In our latest industry survey, half (49%) of all drug developers identified rising costs as the top challenge in 2024.

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Clinical Trials Trials Clinical Research Drug Development 52

PPD

FEBRUARY 3, 2025

In todays clinical research landscape, it is both essential and challenging to accelerate clinical trials. Streamlined regulatory document preparation: Generative AI tools expedite regulatory documentation, reducing administrative bottlenecks and enabling faster compliance with global requirements.

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Drug Target Review

JANUARY 20, 2025

Regulatory alignment : Expertise and experience in meeting FDA and EMA guidelines, ensuring compliance and minimising delays. Adaptive Clinical Trial Design in Oncology: An Overview. Clinical Pharmacology & Therapeutics, 86 (1), 97100. Food and Drug Administration. FDA.gov biotx.ai

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