PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

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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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Vial

MARCH 6, 2024

The field of clinical research is a dynamic and rapidly evolving one. One way to ensure that you are at the forefront of these developments is by attending clinical research conferences. AACR, founded in 1907, is the world’s oldest and largest professional organization dedicated to advancing cancer research.

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Conversations in Drug Development Trends

AUGUST 10, 2023

Sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), the event was the largest psychedelics conference in history, bringing in approximately 12,000 participants and 300+ speakers from around the world. Check out our full psychedelics offering, and meet the team responsible for planning your clinical trial.

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Broad Institute

NOVEMBER 25, 2024

As a proof of concept, a drug designed to target a newly discovered biological node is showing efficacy in treating rare genetic diseases in the kidney, the eye, and the brain and is now making its way to clinical trials in collaboration with a pharmaceutical partner. I’m a rare disease researcher. Visit broad.io/L2C2023

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PPD

SEPTEMBER 16, 2024

In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery. This can be converted to a clinical trial simulator, which can model a clinical trial before the trial design is finalized and initiated.

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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. They also need to have the medical competencies to manage adverse events often associated with these therapies.

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PPD

AUGUST 28, 2024

For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.

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Quanticate

APRIL 12, 2024

The landscape of clinical research is undergoing major changes with virtual clinical trials driving these transformations. These innovative trials promise to revolutionise the way medical research is conducted, making it more accessible, efficient, and patient-centric than ever before.

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Vial

JUNE 24, 2024

The fields of artificial intelligence (AI) and machine learning (ML) are increasingly influencing clinical research and development (R&D). Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery.

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Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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Advarra

JUNE 20, 2023

Typical clinical development timelines for anticancer drugs average an estimated 6.7 Oncology research is unique in many ways, including the challenges researchers face. Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community.

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Vial

FEBRUARY 21, 2024

Clinical trials are needed to determine whether a medical device can produce sufficient proof of its efficacy. However, medical device sponsors and developers are limited by the complex regulatory processes and the high costs associated with the design of running clinical trials for their products.

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Vial

DECEMBER 5, 2023

It has become a fundamental tool for researchers to explore the complexities of genetic information and conduct genetic-informed drug development. Among others, NGS has led to the identification of disease-causing variants and novel drug targets and an improved understanding of complex biological events, e.g., the heterogeneity of tumors.

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Perficient: Drug Development

FEBRUARY 1, 2024

The SCOPE (Summit for Clinical Ops Executives) conference is a premier event in the field of clinical operations, providing a comprehensive platform for professionals to explore the latest trends and innovations in clinical research. Still not registered? Click here !

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron announced today an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC letter is available here: [link]. and Roche will develop, manufacture and distribute it outside the U.S. .

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Olympian Clinical Research

JANUARY 27, 2021

Compulsions can be performed in response to an obsession or independent of obsessions, and are often carried out to reduce anxiety or prevent a dreaded event. If you’d like to learn more about how clinical trials work or want to stay updated with details about our OCD trial and enrollment, then contact our Tampa office today!

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Olympian Clinical Research

SEPTEMBER 7, 2021

Fears about causing some horrific event to happen to themselves or to loved ones. Contact Olympian Clinical Research . At Olympian Clinical Research , we understand the considerable impact that OCD can have upon a person’s quality of life.

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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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Olympian Clinical Research

APRIL 28, 2021

While symptoms for one patient may begin after a specific event or “trigger” (such as a physical trauma, surgery, infection, or significant psychological stress), others may find that their symptoms gradually accumulate over time on their own with no trigger. .

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Olympian Clinical Research

MARCH 31, 2022

Signs may become exacerbated around important events in a person’s life, such as getting married, changing jobs, or moving to a new place. . People suffering from social anxiety typically avoid public situations where others may scrutinize them, or they may rely on alcohol or drugs to face social events. Difficulty making eye contact

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Olympian Clinical Research

APRIL 18, 2023

To learn more about the causes and treatments for HS, Olympian Clinical Research ( OCR ) is hosting a research study on the condition. If you suffer from hidradenitis suppurativa and are considering participating in an HS research study with OCR, this guide will give you an idea of what to expect.

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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. Here, we delve into how these challenges can be navigated with the aid of clinical assessment services, leveraging the expertise of Worldwide Clinical Trials’ Clinical Assessments Technologies (CAT) team.

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Olympian Clinical Research

JANUARY 5, 2022

Early symptoms include difficulty remembering recent events or conversations, forgetting important personal information, and becoming confused about time and place. Contact Olympian Clinical Research. At Olympian Clinical Research, we understand how difficult it can be to cope with a loved one’s Alzheimer’s diagnosis.

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Olympian Clinical Research

JULY 7, 2021

Worrying for days or weeks before an event. When you find yourself taking measures to avoid social situations because of the intense fear, discomfort, or duress these anticipated events cause you, however, it’s possible that social anxiety is at play. . Worrying about embarrassing or humiliating yourself. Social Anxiety Study In Tampa.

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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 is an Electronic Master File (eTMF)? .

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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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Advarra

MARCH 20, 2023

The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may significantly impact early-phase clinical trials of such products. The Benefits of the Umbrella Trial There are many potential benefits to the umbrella trial.

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Vial

MAY 8, 2024

The widespread adoption of EDC technology has revolutionized clinical operations , offering benefits such as improved data management, reduced trial timelines, remote monitoring capabilities, and enhanced data security. EDC is a system used in clinical trials to electronically record and manage subject data.

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Vial

MARCH 15, 2024

The decision to outsource to a CRO is more than a strategic move; outsourcing to a CRO has multiple benefits , including access to streamlined expertise and risk mitigation in clinical trials. Breakdown of CROs Roles Initially, CROs primarily concentrated on overseeing clinical trial site operations and data management.

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Advarra

JUNE 5, 2023

In clinical trials, the safety of research participants is paramount. An organization conducting or sponsoring clinical research can ensure participant safety by convening a data safety monitoring board (DSMB), sometimes called a data monitoring committee (DMC) or independent safety monitoring board (ISMB).

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Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. over the forecast period (2022-2030).

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The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). LY3484356, an oral SERD, is currently being studied in a Phase 1/2 clinical trial. Session Type: Clinical Trials Plenary Session.

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The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. NEW YORK and LONDON, Nov. NEW YORK and LONDON, Nov. and Europe. Dr. Howard L.

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Advarra

NOVEMBER 9, 2023

This blog explores the pivotal role QMS plays in study startup activities as well as how a right-sized QMS contributes to the overall success of clinical trials. Understanding Study Startup Activities Study startup is the phase of a clinical trial occurring after the protocol development and regulatory approval stages.

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