Advarra

JUNE 27, 2023

This article explores how the clinical research phases protect study volunteers from harm and ensure new drugs and therapies are developed effectively. The Importance of Clinical Research in Medical Advancements Researchers use clinical trials to test a drug’s or other medical treatment’s safety and efficacy.

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Conversations in Drug Development Trends

JULY 9, 2024

Challenges in GLP-1 Medication Usage Despite the emerging therapeutic benefits of GLP-1 medications, these treatments also face several challenges, including: Patient Compliance Due to Side Effects One considerable challenge of GLP-1 treatments is their administration method, which is typically a daily injection.

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Conversations in Drug Development Trends

APRIL 8, 2024

Expertly managed clinical assessments by a team with fastidious attention to detail optimizes precision and reliability and helps you successfully navigate the complex terrain of clinical research. Our cohesive approach, characterized by its agility, precision, and collaborative spirit, transforms our partnerships.

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H1 Blog

JULY 30, 2024

The recent draft by the FDA introduces additional guidelines for Diversity Action Plans aimed at improving diversity in clinical research. Hence, pharmaceutical companies need to start making preparations to ensure compliance with the new requirements. billion and taking upwards of 15 years.

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PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

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PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges.

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Vial

FEBRUARY 15, 2024

Sponsors often contract a CRO to delegate specific day-to-day tasks, streamlining their research processes and enhancing efficiency. Patient recruitment and retention : Recruiting and retaining a sufficient number of eligible participants is one of the major challenges in conducting clinical trials.

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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

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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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

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Clinical Trials Trials Clinical Research Compliance 52

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.

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Conversations in Drug Development Trends

APRIL 25, 2024

Understanding and managing post-surgical pain is pivotal in clinical research for improving patient outcomes and care strategies. Compliance Issues: Ensuring consistent patient participation in reporting pain levels post-surgery can be challenging.

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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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Conversations in Drug Development Trends

APRIL 3, 2024

Keeping abreast of changes in regulatory frameworks guarantees compliance and minimizes regulatory-related delays. Imaging Practices Are Key to Optimizing Drug Assessment in Radiopharmaceutical Trials Advanced imaging is integral to the assessment of radiopharmaceuticals, yet it introduces its own set of challenges.

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PPD

OCTOBER 18, 2023

Access to a laboratory partner that already possesses the equipment, knowledge and personnel can save time and money.

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Conversations in Drug Development Trends

AUGUST 15, 2023

You’ll have direct access to our subject matter experts and your counterparts as needed for truly collaborative development. You have the oversight you need. We’re always progressing.

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PPD

DECEMBER 12, 2023

Drug developers using functional service partnerships (FSPs) are taking an increasing interest in the follow-the-sun business model to optimize operations, transitioning work across global locations as the sun rises and sets. Clinical research and post-marketing surveillance involves ongoing data analysis and interpretation.

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Compliance Clinical Research Trials Clinical Trials 52

PPD

NOVEMBER 7, 2023

The underrepresentation of diverse groups in clinical research is an area of regulatory, scientific and industry focus, partly due to the recent U.S. Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.”

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PPD

OCTOBER 4, 2023

Using lab data to help sponsors proactively manage their sites can identify opportunities to improve performance early in the trial that could slow down the drug development process, which would otherwise cost the sponsor both time and money. Helps sites make informed, data-backed decisions and identify trends in query types.

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Conversations in Drug Development Trends

MARCH 20, 2024

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial.

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PPD

DECEMBER 5, 2023

Non-footprint countries are regions where drug developers lack a physical presence, often in emerging markets or remote areas. These countries offer new opportunities for drug developers to access additional resources, ensure project continuity and rely on localized expertise for recruitment, regulatory insights and more.

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H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible. million data points.”

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PPD

JULY 9, 2024

Companies developing new drugs and inventing new medical devices face a wide range of challenges. Most industries have in common the need to meet strict timelines while also achieving quality and compliance standards and staying within budget. However, completing this work is only half the challenge.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Advantages and Operational Challenges in Adaptive MRCTs Adaptive trial designs are gaining popularity in clinical research due to their ability to improve trial efficiency and uphold ethical standards, resulting in faster and more reliable outcomes.

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Vial

MAY 1, 2024

The company has a history of strongly advocating for clinical trials driven by artificial intelligence (AI) using research data captured in a secure, compliant cloud platform to help expedite the drug development process. Read more here about how Vial’s EDC system compares with that of industry giants.

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Vial

DECEMBER 11, 2023

According to a study by the Tufts Center for the Study of Drug Development, the average time from site identification to study start-up completion is approximately 31.4 Site selection and assessment Embarking on the journey of clinical research site start-up begins with the process of site selection and assessment.

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Vial

MAY 13, 2024

Introduction The biopharma industry is poised to make revolutionary advances in and redefine drug development, and the current climate for innovation appears ideal. An estimated 80% of clinical trials do not finish on time. CROs bring their expertise in regulatory compliance and are adept at adapting to changing environments.

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Vial

MARCH 27, 2024

Sponsors must also be cognizant of additional costs associated with more rigorous services such as data management and analysis, maintaining regulatory compliance, and providing individual site monitoring. Personnel salaries, site rentals, and equipment maintenance are other necessary expenses associated with clinical trials.

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Conversations in Drug Development Trends

NOVEMBER 10, 2023

From going to clinic visits and arranging a friend or caregiver to take you to the drive itself and self-care preparation, it’s truly a horrible position to be in.  I contemplated how a decentralized trial model may be more conducive to participant compliance and study satisfaction. The

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Perficient: Drug Development

SEPTEMBER 25, 2024

Limited data accessibility : Researchers frequently lack efficient ways to access and interpret the specific data relevant to their roles. Collaboration barriers : Disparate teams often struggle to share insights and work cohesively, slowing down the research process.

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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

JANUARY 6, 2025

Regulatory Compliance and Ethical Considerations Adaptive trials, although flexible and efficient, must adhere to strict regulatory and ethical standards. Real-World Data Integration Another emerging trend in clinical research is integrating real-world data (RWD) into the designs of adaptive trials.

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Trials Clinical Trials Treatment Disease 75

Conversations in Drug Development Trends

AUGUST 15, 2023

You’ll have direct access to our subject matter experts and your counterparts as needed for truly collaborative development. You have the oversight you need. We’re always progressing.

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Molecule Blog

MARCH 17, 2023

The activities of a BioDAO encompass funding R&D investments and other functions such as community education, company formation, project incubation, access to expertise and knowledge, networking opportunities, member data aggregation, and assistance with regulatory compliance and various challenges.

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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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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. Yet, it becomes a manageable aspect of drug development with careful planning, strategic engagement, and flexible problem-solving.

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