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.

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Vial

DECEMBER 4, 2023

Clinical research is an integral component of the healthcare ecosystem. The success of clinical research hinges crucially on patient participation; however, attracting and retaining participants can often pose significant challenges. Patient Payments in Clinical Research: Perception Over the Years In the U.S.,

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. By Julie Kim & Deborah L. No word yet on whether FDA will issue guidance endorsing the final ICH E6(R3).

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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. This aims to ensure that treatments are effective across varied demographics and to address historical gaps in clinical research.

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PPD

FEBRUARY 10, 2025

In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.

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Advarra

MARCH 14, 2023

Review sessions: Enable organizations to grant limited eReg access to both internal and external monitors in order to more easily review documents. The post eReg Benefits for Clinical Research: Use Cases for all Types of Sites appeared first on Advarra. Investigational new drugs (INDs): Storage for INDs.

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PPD

DECEMBER 16, 2024

The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinical research business of Thermo Fisher Scientific.

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Quanticate

JULY 5, 2024

It’s essential for maintaining ethical standards, high-quality outcomes and facilitating global standardisation, enabling multi-center and multinational studies, thereby streamlining the development and approval process for new medical treatments, and maintaining public trust in clinical research.

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PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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Olympian Clinical Research

SEPTEMBER 3, 2020

Eating a well balanced diet, full of fruits and vegetables, floods your body with antioxidants that then decrease the internal inflammation contributing to and/or caused by depression. . The post Battling Depression In A World Of Isolation: Tips For Managing COVID Depression appeared first on Olympian Clinical Research.

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Broad Institute

JANUARY 24, 2024

The platform has helped us to more efficiently store and reuse data while broadening access to more of our VUMC researchers. Now that Terra is on Azure, we are excited to align our use of Terra with our internal IT strategy.”

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PPD

JUNE 7, 2023

By partnering with a contract research organization (CRO) that understands the challenges of liver disease clinical trials — and the complexities of working with pediatric populations — you can drive your treatment forward. Partnership with an experienced CRO is essential to your trial’s success.

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The Pharma Data

MAY 6, 2021

INDIANAPOLIS , May 6, 2021 /PRNewswire/ — With a goal of integrating data and technology to help streamline diabetes management, Eli Lilly and Company (NYSE: LLY) signed strategic international agreements with four companies – DexCom, Inc., 1 International Diabetes Federation. Glooko Inc. About Glooko Inc. Available at: [link].

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PPD

SEPTEMBER 6, 2023

Examples of Hybrid Outsourcing Strategies for Clinical Trials For biotech and biopharmaceutical organizations, a strong CRO partner with broad experience in both FSO and FSP engagements is necessary to guide the right mix of service models to use.

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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. Collaborate and connect by leveraging biomarker-specific visualizations (e.g.,

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PPD

AUGUST 5, 2024

Global expertise and 7 key lessons learned The PPD clinical research business of Thermo Fisher Scientific has extensive history working with PAH clinical trial sites globally (more than 3,500 sites across 53 countries in the past five years). From that experience, we offer seven key takeaways.

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Advarra

MAY 14, 2025

With a decade of experience as regulatory counsel in the FDAs Center for Drug Evaluation and Research Office of Scientific Investigations, her experience will help Advarras clients and internal teams navigate the ever-shifting regulatory landscape for human subjects research.

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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. If you’re interested in discussing your rare disease program, check out our rare disease services at Worldwide.

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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.

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Drug Target Review

APRIL 7, 2025

International Journal of Molecular Sciences. About the author Dr Cyril Clarke, Vice President, Therapeutic Area, GMI Drug Development and Consulting, ICON Biotech Clarke is a clinical pharmacologist with over 30 years experience in clinical research; seventeen of which are within industrial clinical pharmacology.

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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.

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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. The post The Evolution of Clinical Quality: Key Considerations from ICH E6 R3 appeared first on Advarra.

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Conversations in Drug Development Trends

JANUARY 6, 2025

Global Collaboration and Data Sharing International collaboration and data sharing are crucial for advancing adaptive trial designs. By pooling data from multiple trials across various regions, researchers can increase the power and relevance of their findings.

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Advarra

FEBRUARY 13, 2024

Every day, clinical research organizations work to deliver a seamless user experience for their staff, while also providing robust security measurements to protect their data and stay compliant. Users can log in via SSO once using their credentials, with no need to re-authenticate to access other internal applications leveraging SSO.

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The Pharma Data

JUNE 26, 2021

About European Organization for Research and Treatment of Cancer European Organization for the Research and Treatment of Cancer (EORTC) is an academic clinical research organisation which unites clinical cancer research experts across the globe to define better treatments for cancer patients to prolong survival and improve quality of life.

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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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The Pharma Data

JANUARY 27, 2021

“Our commitment to supporting clinical research sites with strategic flexible resources has been increasingly important over the past 12 months in particular. “Our commitment to supporting clinical research sites with strategic flexible resources has been increasingly important over the past 12 months in particular.

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PPD

OCTOBER 9, 2023

One example of patient engagement, satisfaction and retention is a rare disease study conducted by the PPD clinical research business of Thermo Fisher Scientific. Protocol adherence support: A patient based in the U.S.

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Advarra

JUNE 18, 2024

Clinical research is complex and resource-intensive, and to understand just how far an organization’s resources can go, assessing a study’s feasibility is critical for success. Evaluating feasibility elements enable organizations to make informed decisions and allows for seamless execution and reporting of clinical studies.

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Advarra

OCTOBER 31, 2023

A common misconception in the manufacturing and research development landscape is quality systems can be bought off the shelf and there are no significant differences among the proliferation of quality systems. Clinical research is grounded in scientific integrity, participant safety, and data reliability.

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Advarra

JULY 18, 2022

To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. What Documents are in an eISF?

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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.

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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.

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The Pharma Data

DECEMBER 11, 2020

Among the targets, the majority are vaccine makers that have COVID-19 vaccines in various stages of clinical trials. One is a clinical research organization involved in trials, and one has developed a COVID-19 test,” Microsoft said.

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thought leadership

JULY 20, 2023

Good clinical practice ( GCP ) is an international ethical analysis and scientific quality standard for designing, conducting, and auditing clinical trials that involve the participation of human subjects. This article has been updated since it's original publication date.

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H1 Blog

APRIL 2, 2025

In a recent discussion , Dija Atta, Head of Regional Clinical Operations, and Stacy Eckstein, Manager of Global Trial Informatics, shared how Incyte is taking meaningful steps toward more inclusive research. From launching internal initiatives to leveraging internal data and real-world data, their team is setting new standards. "As

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PPD

JULY 16, 2024

To institutionalize the systems and processes related to these new reporting requirements, our PPD FSP Pharmacovigilance solutions team first had to undertake extensive research into the adoption of International Conference on Harmonisation (ICH) guidelines in China.

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