Agency IQ

DECEMBER 11, 2023

At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. So far, the key takeaway was that both industry and regulators are still identifying best practices on setting enrollment targets in their research plans.

Research 52

Research Clinical Research FDA Regulations 52

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). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

Clinical Trials 52

Clinical Trials Regulations Trials Pharmaceutical Companies 52

Advarra

MARCH 5, 2024

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. Note: This article was originally published December 4, 2019, and has been updated to include new and clarifying information.

Regulations 52

Regulations Clinical Research Research Government 52

Agency IQ

AUGUST 18, 2023

The new guidance offers recommendations for institutional review boards (IRBs), investigators and sponsors on key aspects of informed consent, significantly expanding FDA’s recommendations on several key topics, including reimbursement for research participation. government, so FDA’s regulations are technically parallel to HHS’.

FDA 40

FDA Regulations Trials Research 40

Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. AgencyIQ thought this would be a good time to go over what a government shutdown means for the FDA, and therefore what regulated industry needs to know. What are the impacts for regulated industry?

Government 40

Government FDA Biosimilars Regulations 40

Advarra

DECEMBER 1, 2022

In the past several years, Health and Human Services (HHS) Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) have announced and/or implemented new regulations to address the challenges of conducting clinical trials involving multiple research sites.

Regulations 52

Regulations Compliance FDA Clinical Trials 52

Vial

FEBRUARY 21, 2024

Medical device sponsors often seek out CROs so they can outsource services such as clinical research, site selection, trial design, and regulatory consulting. In this article, we will explain the benefits of outsourcing medical device clinical trials to CROs and how doing so can provide sponsors with a competitive advantage.

Clinical Trials 52

Clinical Trials Trials Compliance Regulations 52

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. Policy-wise, this is still a work in progress.

FDA 40

FDA Research Clinical Trials Trials 40

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 40

FDA Therapies Clinical Trials Disease 40

Agency IQ

FEBRUARY 2, 2024

This collaboration examining trial formats involved “numerous discussions with regulators, including the US FDA and the EMA Innovation Task Force,” as well as workshops. Both regulators recommend that investigators initiate a conversation about approaches to biomarker and master protocol use, to ensure regulatory requirements are met.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA 40

FDA Production Regulations Vaccine 40

Agency IQ

AUGUST 11, 2023

The company highlights several applications relevant to life sciences regulation, including pharmacovigilance and quality assurance and regulatory compliance management. These inspections are used by FDA to assess sites involved in clinical research, and involve activities such as inspections, data audits and more.

FDA 40

FDA Compliance Clinical Trials Pharmacokinetics 40

Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What do the Regulations Say about IBC Review? The post IBC vs. IRB: What’s the Difference?

Engineering 98

Engineering Therapies Regulations Research 98

Vial

JUNE 24, 2024

The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.

Clinical Trials 52

Clinical Trials Trials Clinical Research Treatment 52

Vial

MAY 28, 2024

In the rapidly expanding world of digital health, Medable and Vial CRO (Contract Research Organization) , two leading technology organizations, are revolutionizing the way clinical research is conducted.

Clinical Trials 52

Clinical Trials Clinical Research Trials Compliance 52

Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Vial

FEBRUARY 15, 2024

According to the 2022 Polaris Market Research Report , the global clinical trials outsourcing market reached USD 38.11 This article discusses current challenges in managing clinical trials and elucidates the pivotal role that CROs play in overcoming these obstacles. over the forecast period (2022-2030).

Pharma Companies 52

Pharma Companies Clinical Trials Compliance Trials 52

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 52

Clinical Trials Trials Clinical Research Compliance 52

KIF1A

JULY 1, 2023

This activity may be regulated by the K-loop, which is known to be important for KIF1A’s long-range movement. But drug R&D is an uncertain process, and many therapeutics get shelved during preclinical or clinical research, before they ever reach a patient.

Small Molecule 98

Small Molecule FDA Approval Disease Pharmaceutical Companies 98

Vial

MARCH 15, 2024

Nonetheless, while CROs play a pivotal role in streamlining operations and providing specialized expertise, sponsors continue to bear critical responsibilities throughout the clinical trial journey. Data quality and management : Managing and analyzing the huge volume of data produced in a clinical trial often proves challenging.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 52

Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. How and What to measure?

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

Vial

FEBRUARY 23, 2024

In 2022, the global market value of patient portals within the clinical research and healthcare industries was estimated to be US $2.9 To learn about the history of these trial technologies and their adoption within the clinical research industry, read more here !

Clinical Trials 52

Clinical Trials Clinical Research Trials Hospitals 52

Vial

MAY 1, 2024

Among the leading contract research organizations (CROs) providing these technologies are Castor, with its established reputation for reliable EDC technology, and Vial CRO, a newer player quickly becoming well-known for its digital innovation. Read more here about how Vial’s EDC system compares with that of industry giants.

Clinical Trials 52

Clinical Trials Trials Compliance Engineering 52

Agency IQ

NOVEMBER 3, 2023

In simpler terms, these are live microbes that have actually demonstrated health benefits in clinical research. Keep in mind that this is the definition developed by ISAPP – there is no regulatory body confirming that any product on the market referred to as a “probiotic” has actually demonstrated benefits in clinical research.

Therapies 40

Therapies Science FDA Production 40

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 52

Clinical Trials Drug Development Trials Clinical Research 52

Vial

DECEMBER 5, 2023

The application of NGS has given researchers deep insights into genetic variation, gene expression, epigenetic modifications, alternative splicing, non-coding RNA regulation, microbial diversity, and various biological processes and diseases. Conclusion NGS has tremendous potential for advancement and application in clinical research.

Clinical Trials 52

Clinical Trials Trials RNA Bioinformatics 52

Advarra

OCTOBER 14, 2022

In the context of decentralized clinical trials (DCTs), we have seen an explosion of new devices and apps interacting with participants and collecting information throughout a trial, all with the participant never setting foot in a traditional clinical research site. What is this innovation?

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

The Anticancer Fund

JUNE 23, 2023

Our intention is to help bring these findings to the attention of the broader cancer research community. Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context.

Drugs 52

Drugs Trials Clinical Trials Treatment 52

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

The Anticancer Fund

SEPTEMBER 29, 2021

Our intention is to help bring these findings to the attention of the broader cancer research community. Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context.

Clinical Trials 40

Clinical Trials Drugs Trials Protein Expression 40

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. At a February 2024 joint workshop with the U.S. Next, the U.S.

Regulations 40

Regulations Trials Clinical Trials Science 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

FDA 40

FDA Trials Therapies Regulations 40

The Anticancer Fund

JUNE 7, 2022

Our intention is to help bring these findings to the attention of the broader cancer research community. Being listed is no endorsement of the results and conclusions of the article. All articles need to be critically assessed and viewed in their broader research context.

Clinical Trials 40

Clinical Trials Drugs Trials Treatment 40

Agency IQ

SEPTEMBER 1, 2023

For example, in September 2022 the FDA finalized a guidance document on how sponsors of drug product submissions could effectively flag RWE for regulators. These evaluations will inform the suitability of the data source to the clinical research question and estimate how precise its outcomes may be.

FDA 40

FDA Science Regulations Production 40

Codon

JULY 21, 2024

Xander Balwit offers concrete proposals for raising the welfare of animals used in biomedical research for our final article in Issue 03. This is due, in part, to perceptions of public safety, and by extension, regulation. We’ll be on a brief hiatus for the next few weeks as we prepare for the next Issue!

Research 114

Research Engineering Disease Science 114

The Pharma Data

NOVEMBER 10, 2020

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. NEW YORK and LONDON, Nov. The person who arranged for the release of this announcement on behalf of the Company was Dr Kunwar Shailubhai, Chief Executive Officer and Chief Scientific Officer of the Company.

Clinical Trials 40

Clinical Trials Science Disease Trials 40

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. Combination products are defined by the FDA as : “A product comprised of two or more regulated components (i.e.,

Science 40

Science FDA Production Trials 40