PPD

FEBRUARY 10, 2025

A recent white paper from the PPD clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

Clinical Research 52

Clinical Research Therapies Research Vaccine 52

PPD

JUNE 7, 2023

Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

Trials 98

Trials Clinical Trials Clinical Research Disease 98

Drug Target Review

SEPTEMBER 5, 2024

However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Pharma Companies Licensing Licensing Disease 111

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. 1 Over a quarter of those were for basic research purposes, with most common areas focused on the immune system, the nervous system and oncology. In Britain, 2.88 2020 [cited 2023Feb24]. 2022;12(7):3049–62.

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Animal Testing Drugs Clinical Trials Clinical Research 105

PPD

MARCH 13, 2024

The role of the clinical logistics monitor (CLM) is a focal point of contact and an escalation point to the internal and external teams. As a conduit, their role is to assess the timelines together, being the liaison with the manufacturing organization and implementing risk management and mitigation.

Clinical Development 98

Clinical Development Clinical Trials Therapies Trials 98

PPD

OCTOBER 31, 2023

If recruitment moves slowly or individuals with the wrong skills are selected, the clinical research process stalls, costing sponsors valuable time, money and resources. Selecting the Right Partnership Model Clinical research outsourcing models have changed over time to accommodate the industry’s evolving needs.

International 52

International Clinical Research Clinical Development Research 52

PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 52

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

PPD

JULY 18, 2023

Nearly two-thirds of drug developers’ outsourcing budgets are now allocated to functional service provider (FSP) models or FSP hybrid models, according to research conducted by the PPD clinical research business of Thermo Fisher Scientific. Ready to work with a transformative FSP partner?

Clinical Development 52

Clinical Development Drug Development International Clinical Research 52

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. Vial adopts a fixed-fee pricing model devoid of change orders to streamline cost-effectiveness in drug development.

Clinical Trials 52

Clinical Trials Trials Clinical Research 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

Alta Sciences

SEPTEMBER 13, 2023

Pain models can be important clinical tools to characterize a novel analgesic, and determine its potential effectiveness in models simulating varying pain stimuli. Here are four main pain models we use to assess treatments in clinical trials: 1. WHY IS PAIN RESEARCH SO IMPORTANT?

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

Conversations in Drug Development Trends

AUGUST 9, 2024

However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. The International Council for Harmonisation of Technical Pharmaceuticals for Human Use provides guidelines, but local adaptations and interpretations still vary.

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Trials Clinical Trials Regulations FDA 80

Vial

MARCH 25, 2024

Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members. According to Hardman et al.,

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

The Pharma Data

NOVEMBER 1, 2020

Dr Nurbhai has more than 25 years of experience and a strong track record in the strategic and operational leadership of all phases of clinical research and development at companies across Europe and the US. Prior to VHsquared, Suhail was Senior Vice President and Head of Development and Medical Affairs for Shionogi in Europe.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 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

Vial

MARCH 27, 2024

The type of sponsorship must also be accounted for because academic institutions sponsoring clinical trials often have access to fewer financial resources compared with commercial sponsors, which typically have larger budgets for their drug development programs.

Clinical Trials 52

Clinical Trials Trials International Compliance 52

Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

Drugs 111

Drugs FDA Disease Animal Testing 111

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

PerkinElmer

FEBRUARY 18, 2021

Which high throughput screening (HTS) approach is the most productive in finding hits for drug development: target-based or phenotypic? These simple, stable compounds, used to treat various conditions, are the focus for 78% of preclinical research. Outsourcing is filling internal gaps when it comes to screening.

Biochemical Assays 52

Biochemical Assays Drugs Small Molecule Pharma Companies 52

PPD

JUNE 17, 2024

When outsourcing some or all key functions to an FSP provider, a drug developer gains access to a wider pool of talent, including specialized functional, scientific and technical experts. This approach enables unbroken continuity of support and resources across clinical trial operations.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52

PPD

DECEMBER 19, 2023

According to industry figures, the use of FSP models grew from 28% to 41% in just three years (2018-2021); by 2022, our internal research shows that nearly two-thirds of outsourcing budgets were allocated to FSP or hybrid FSP/FSO models. Ready to fuel more efficient drug development?

International 52

International Research Drug Development Pharmaceuticals 52

Conversations in Drug Development Trends

NOVEMBER 3, 2022

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. enrollment by diversifying U.S. altogether.”.

Disease 52

Disease Clinical Trials Trials International 52

Conversations in Drug Development Trends

APRIL 3, 2024

Our experience also shows that providing adequate continuing education materials to internal site-level committees is particularly important; doing so ensures that each site is always in compliance and provides a smoother study process.

Trials 81

Trials Clinical Trials Compliance Treatment 81

Drug Target Review

DECEMBER 13, 2024

Antibody-drug conjugates treatment of small cell lung cancer: advances in clinical research. Fcgamma Receptor-Dependent Internalization and Off-Target Cytotoxicity of Antibody-Drug Conjugate Aggregates. Antibody-drug conjugates: Principles and opportunities. Meng Y, Wang X, Yang J, Zhu M, Yu M, Li L, et al.

Therapies 98

Therapies Treatment Clinical Trials Drugs 98

The Pharma Data

JANUARY 13, 2021

Optimum Strategic Communications (International Media and European Investor Enquiries). . Tel: +1 212-600-1902 verona@argotpartners.com. Kimberly Minarovich / Michael Barron. . . . .

Hospitals 52

Hospitals Clinical Trials Therapies Treatment 52

The Pharma Data

DECEMBER 15, 2020

At present, the company has developed a number of original new drug product lines for oncology, metabolic diseases, autoimmune diseases, central nervous diseases, and antiviral diseases. View original content: [link].

Pharmaceuticals 40

Pharmaceuticals Clinical Trials Small Molecule Disease 40

Drug Target Review

OCTOBER 25, 2024

The Role of Biomarkers in Alzheimer’s Disease Drug Development. Alzheimer’s Association International Conference; 2024 July 28 – August 1; Philadelphia, PA. A how-to guide for a precision medicine approach to the diagnosis and treatment of alzheimer’s disease. link] Cummings J. Adv Exp Med Biol. 2019;1118:29-61.

Disease 59

Disease Clinical Trials Therapies Science 59

The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. He currently serves as chair of the medical and scientific advisory group and as a member of the Board of Directors of the Alzheimer’s Association.

Disease 40

Disease Clinical Development Molecular Biology Treatment 40

Molecule Blog

MARCH 17, 2023

Biopharma R&D is gravitating toward increased decentralization, outsourcing much high-risk work to specialist contract organizations while keeping IP and data storage centralized internally. BioDAOs, however, offer an alternative by federating IP and data on Ethereum instead of keeping them siloed.

Engineering 52

Engineering Research Clinical Trials Government 52

The Pharma Data

OCTOBER 22, 2020

In parallel with the clinical trials of Veklury, we worked to rapidly expand drug supply, knowing that if proven effective, there would be significant patient need for Veklury. In clinical research, the gold standard for demonstrating the efficacy and safety of a drug is the randomized, double-blind, placebo-controlled trial.

Science 52

Science Clinical Trials Hospitals Trials 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. she explained, including Central and South America and Africa.

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FDA Research Clinical Trials Trials 40

Agency IQ

OCTOBER 27, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016.

FDA 40

FDA Science Regulations Production 40

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. For example, there are accelerated pathways for oncology drug approval in the U.S., Japan, and China. and the U.S.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

Conversations in Drug Development Trends

JANUARY 24, 2024

However, clinical research around Fragile X is considerably robust, making the possibility of clinical trial participation a potential motivation for parents to choose to undergo genetic testing for their children. These datasets can help find providers and patients based on genetic information.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Precision for Medicine

JANUARY 23, 2023

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. About QuartzBio QuartzBio helps overcome the data chaos inherent in modern drug development.

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Clinical Research Research Clinical Development Engineering 40