PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution.

Therapies 52

Therapies Clinical Trials Clinical Research Trials 52

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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FDA Clinical Trials Compliance Pharma Companies 59

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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Clinical Trials Trials Compliance Clinical Research 52

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.

Packaging 52

Packaging Laboratories Pharmaceutical Companies Compliance 52

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.

Pharma Companies 52

Pharma Companies Clinical Trials Compliance Trials 52

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.

Clinical Trials 75

Clinical Trials Clinical Research Trials Compliance 75

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.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

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.

Clinical Research 59

Clinical Research Regulations Packaging Drug Development 59

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.

Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

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.

Clinical Trials 52

Clinical Trials Compliance Trials Clinical Research 52

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.

Compliance 52

Compliance Clinical Research Trials Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

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.

Clinical Trials 52

Clinical Trials Trials Compliance Laboratories 52

PPD

OCTOBER 18, 2023

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

Laboratories 52

Laboratories Assay Development Small Molecule Drug Development 52

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.

Clinical Trials 52

Clinical Trials Trials Treatment Compliance 52

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.

Clinical Development 52

Clinical Development Clinical Research Drug Development International 52

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.

Compliance 52

Compliance Production Clinical Research Marketing 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.”

Clinical Trials 59

Clinical Trials Trials Clinical Research Disease 59

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.

Clinical Trials 52

Clinical Trials Trials Compliance Engineering 52

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.

Clinical Trials 52

Clinical Trials Clinical Research Trials Research 52

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.

Clinical Trials 52

Clinical Trials Trials Drug Development Production 52

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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Trials Clinical Trials Compliance Treatment 81

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.”

Clinical Trials 59

Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 59

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.

Clinical Trials 52

Clinical Trials Trials Science Production 52

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.

Clinical Trials 52

Clinical Trials Trials International Compliance 52

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.

Trials 80

Trials Clinical Trials Regulations FDA 80

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.

Clinical Development 98

Clinical Development Government Clinical Trials Trials 98

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.

Clinical Trials 52

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.

Clinical Trials 52

Clinical Trials Trials Treatment Clinical Research 52

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.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

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

Clinical Trials 75

Clinical Trials Trials Compliance Treatment 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.

Clinical Development 52

Clinical Development Government Clinical Trials Trials 52

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.

Engineering 52

Engineering Research Clinical Trials Government 52

PPD

NOVEMBER 8, 2022

As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023. Six Predictions for the Drug Development Industry in 2023 1.

Clinical Trials 52

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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FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 1, 2023

“FDA does not consider these types of studies to be clinical investigations under part 312, and an IND is not required,” the guidance explains. However, sponsors will still need to ensure the protection of the subjects in their study, including through compliance with 21 CFR parts 50 and 56.

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FDA Science Regulations Production 40