Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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Advarra

NOVEMBER 14, 2024

Strengthened regulatory compliance: Different countries have varying regulatory requirements and expectations. This compliance is crucial for the successful regulatory approval and dissemination of trial results. For example, consider a global Phase III, double-blind study, in a novel new therapy.

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Advarra

MARCH 20, 2023

The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may significantly impact early-phase clinical trials of such products. This article explores the implications of this guidance, including new approaches for studies focused on cellular or gene therapies.

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FDA Law Blog: Drug Discovery

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Her expertise spans a range of critical areas including: human subject protections, clinical trial conduct, development strategies, FDA interactions, and enforcement action responses. Hyman, Phelps & McNamara, P.C.

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Advarra

AUGUST 21, 2024

However, some industries like healthcare and clinical research have had a more fragmented experience in the adoption and seamlessness of their digital experience. Nowhere is this more painful than in clinical trials, the backbone of drug development. However, it is often unengaging, cumbersome, and manual.

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PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Complexity: PAH trial sites are complex and require highly experienced clinicians, researchers and support staff.

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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.

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PPD

OCTOBER 31, 2024

In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends. Furthermore, the development of innovative therapies often necessitates intricate protocols, adding layers of complexity to trial management.

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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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Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. Are you aware of the challenges you must address for a successful radiopharmaceutical trial?

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Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. As von Itzstein et al.

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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.

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Vial

APRIL 10, 2024

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. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

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PPD

JUNE 29, 2023

Although several corticosteroid treatments are available as first-line treatments, drug developers continue to seek more effective therapies to improve the wellbeing of those diagnosed with atopic dermatitis. But developing treatments for atopic dermatitis is complex and competitive.

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Olympian Clinical Research

SEPTEMBER 7, 2021

Resist the urge that may try and bully you into compliance – that urge is pathological and does not need to be obeyed. Cognitive behavioral therapy can be helpful in managing thoughts, identifying behaviors, and understanding why you are having these impulses in the first place. Contact Olympian Clinical Research .

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Clinical Trials Clinical Research Trials Compliance 52

Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. R3 acknowledges no clinical trial can be flawless, but it encourages organizations to adapt their processes and systems to address the most critical risks effectively.

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PPD

DECEMBER 12, 2023

Navigating the Intricacies of the Follow-the-Sun Model in Clinical Research The implementation of a follow-the-sun model, which leverages global resources in different time zones to assure continuous operations, requires a thoughtful approach to cultures, communication and collaboration for effective results.

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PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030.

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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 Does an IBC Review?

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Vial

DECEMBER 11, 2023

Despite the essential role of the clinical research industry, initiating a clinical study at a new site often takes a considerable amount of time, which can postpone the overall timeline of the research. These documents are reviewed to ensure they are in compliance with ethical guidelines. Observational.

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Advarra

JUNE 13, 2024

Because these therapies often use live viral vectors, there is the risk of accidental transmission that is not encountered with non-biological drugs and therapeutics. Synthetic mRNA-based therapeutics used in clinical research today also fall into this self-limiting class of recombinant therapeutics.

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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.

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Clinical Trials Trials Compliance Clinical Research 52

Advarra

APRIL 27, 2023

Clinical research aims to produce knowledge in the service of treating diseases and improving human health. In a just and well-functioning society, the benefits of research would ideally be shared equitably among all social groups, regardless of race, age, gender, or ethnicity. This gives the research community (e.g.,

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Clinical Trials Research Trials Clinical Research 52

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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Clinical Research Research Compliance Clinical Trials 52

Advarra

MAY 26, 2023

MCA is a systemic process of developing a billing plan for a clinical research study, which provides an in-depth analysis of how all the items and services listed in the clinical research protocol are billed per Medicare-provided guidelines.

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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

Vial

DECEMBER 13, 2023

A site satisfaction survey conducted by Greenphire revealed that sites and sponsors both seek opportunities to improve clinical trial processes. The 2023 State of Clinical Trial Technology Report by Florence Healthcare presents insights from 450 clinical research sites, sponsors, and CROs.

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Clinical Trials Trials Clinical Research Research 52

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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Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Ultimately, our goal is to bring safe and effective new therapies to patients.

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The Pharma Data

NOVEMBER 10, 2020

Now, the device has passed compliance tests for medical devices in the EU, including safety, electromagnetic compatibility, biocompatibility, etc. While the world is facing a severe shortage of specific antiviral drugs, a new treatment developed by Asclepius Meditec highlights the potential of hydrogen-oxygen therapy in tackling COVID-19.

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The Pharma Data

NOVEMBER 10, 2020

However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies. Additionally, oral capsules provide the convenience of home use, and increase patient compliance by eliminating the need for infusions in a clinic or hospital setting. “The NEW YORK and LONDON, Nov.

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Advarra

SEPTEMBER 20, 2022

Besides the cost to sponsors, with new therapies taking between 10 – 15 years to reach patients, aligning with the top-performing sites is critical to minimizing this agonizingly long cycle time. Ultimately, however, decreased trial cycle times and faster delivery of new therapies means patients are the real winners.

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The Pharma Data

MAY 6, 2021

ENVI also urged the Commission to develop appropriate regulatory frameworks for advanced therapy medicinal products and to work with EMA “to consider extending the application of rolling reviews to other emergency medicines.” Specifically, wholesalers should conduct in-depth audits to verify full compliance with EU GDP requirements.

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Advarra

NOVEMBER 10, 2022

This blog highlights some of the major proposed changes and how they may impact the clinical research community. . These notices proposed harmonization with the Health and Human Services (HHS) 2018 Common Rule (also referred to as the revised Common Rule ).?This Consistent Human Subject Protection Requirements .

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Agency IQ

MARCH 1, 2024

We’re waiting to hear more about the status of the proposal to extend the compliance deadlines for the IVD regulation and will keep our eyes open for news on when exactly we can expect it to go through. The file will head to the Parliament for a vote next. Device news is unsettled.

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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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Clinical Trials Trials Drug Development Clinical Research 52

Agency IQ

OCTOBER 27, 2023

What When it might happen Additional details FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. Comments on the proposal closed on July 19. Once published, the 180-day amnesty period will start.

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