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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Clinical Research Research Compliance Clinical Trials 52

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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Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

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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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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Clinical Trials Treatment Clinical Research Trials 98

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].

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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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Trials Clinical Trials Clinical Research Disease 98

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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International Therapies Disease Production 52

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.

Drug Development 98

Drug Development Clinical Trials Drugs Clinical Research 98

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.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 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.

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International Clinical Research Clinical Development Research 52

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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Clinical Development Clinical Trials Therapies Trials 98

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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Clinical Trials Trials Clinical Research International 52

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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Clinical Trials International Trials Therapies 52

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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Compliance Clinical Research International Research 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

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.

Clinical Research 40

Clinical Research Clinical Trials International Clinical Development 40

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.

Clinical Trials 98

Clinical Trials Trials Compliance International 98

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.

Clinical Trials 97

Clinical Trials Trials Clinical Research International 97

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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Compliance Clinical Research Clinical Trials Trials 52

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?

Research 52

Research Clinical Trials Compliance Regulations 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

Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated.

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 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

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.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

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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Clinical Trials Trials Clinical Research International 40

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.

Compliance 98

Compliance Regulations Production Trials 98

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. 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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PPD

AUGUST 14, 2023

Click to enlarge PPD® Functional Service Partnership (FSP) solutions provide a wide range of reliable and customizable resources to support key functional areas, fill gaps in internal capabilities or enhance functional expertise.

Pharmaceutical Companies 52

Pharmaceutical Companies Clinical Research International Production 52

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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Clinical Trials Trials Clinical Research Research 52

The Pharma Data

DECEMBER 24, 2020

. “Based on our results, if there is a risk difference, it’s marginal and would be very challenging to further refine outside such a large-scale international study,” Suchard said. ” © 2020 HealthDay.

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Advarra

AUGUST 1, 2023

Efficient and compliant data capture can make or break the success of a clinical research trial. For example, if there are questions about lab results, staff can work internally with the care team to identify any clinically significant findings. Defining eSource and EDC First, it may be helpful to define e Source and EDC.

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Compliance Clinical Research Trials Research 52

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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Clinical Trials Trials Clinical Research Compliance 52

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.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

Advarra

DECEMBER 5, 2023

The ability to generate and create financial records, invoicing, and any number of tools allowing customers the ability to use the system to track almost every piece of the clinical research lifecycle – everything pertaining to a trial. The data collection process for a clinical trial has numerous steps.

Clinical Trials 52

Clinical Trials Clinical Research Trials Research 52

Advarra

SEPTEMBER 30, 2022

Is the clinical research industry winning or failing at innovation? Despite the fast pace of medical innovation, the lack of consistency between technology systems managing these advancements ultimately inhibits research progress. . Has innovation really succeeded in clinical research if this is the state we’re currently in?

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Research Clinical Research Trials FDA Approval 52

PPD

DECEMBER 5, 2023

By doing so, companies can augment their ongoing clinical research and sidestep the challenges of global extension, such as language barriers and compliance concerns, without the need to manage the in-country presence themselves. This facilitates smooth, on-schedule operations, de-risking the pipeline.

Clinical Development 52

Clinical Development Clinical Research Drug Development International 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. So while Ansel said he’s seen many sponsors of orphan drugs successfully diversify U.S.

Disease 52

Disease Clinical Trials Trials International 52