ACRP blog

OCTOBER 19, 2023

Research sites play a pivotal role in clinical trials in that they are responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. This makes it difficult to gain the visibility needed to make intelligent, data-driven decisions. This is a sponsored message.

Clinical Research 105

Clinical Research Research Compliance Clinical Trials 105

Rethinking Clinical Trials

JULY 10, 2023

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee Meeting in May, Keith Marsolo, PhD, Co-Chair of the Electronic Health Records Core , reflected on data sharing experiences from the program and factors affecting the meaningful re-use of data. Most studies have only had one or two requests for data.

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Trials Clinical Trials Clinical Trials Containment 130

Rethinking Clinical Trials

JANUARY 16, 2024

AIM-CP will address test a care management program to address inequities in access to nonpharmacological treatment for chronic pain in rural populations. Ethics and regulatory documentation for all of the NIH Collaboratory Trials is available on our Data and Resource Sharing page. Learn more about AIM-CP.

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Trials Clinical Trials Clinical Trials 141

Cloudbyz

APRIL 16, 2023

However, the process of managing clinical trials is complex and time-consuming, requiring significant financial and human resources. One solution is the implementation of a unified clinical trial management platform. What is a Unified Clinical Trial Management Platform?

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Clinical Trials Clinical Trials Trials Compliance 52

Rethinking Clinical Trials

FEBRUARY 28, 2024

But there are concerns to developing DCTs including lack of standardization and validation, regulatory and ethical uncertainties, engagement vs. coercion, data security and privacy issues, technological literacy and access, resistance to change and adoption, and lack of “safe” sharing. from 2021 to 2026.

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Clinical Trials Clinical Trials Trials Clinical Research 141

Cloudbyz

APRIL 6, 2023

However, managing clinical trials is a complex and challenging task, especially for research institutes that are already stretched thin. UCTMS provides a centralized platform for managing various aspects of the clinical trial process, including patient recruitment, scheduling, data collection, and analysis.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

Cloudbyz

SEPTEMBER 28, 2023

In the ever-evolving world of clinical research and life-sciences, the efficient and accurate collection of data is paramount. Researchers and clinical trial professionals are constantly seeking innovative solutions to streamline the data collection process, improve data quality, and enhance overall efficiency.

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Life Science Clinical Research Clinical Trials Clinical Trials 107

Cloudbyz

MARCH 11, 2024

Electronic Trial Master Files (eTMFs) play a pivotal role in the clinical trial process, serving as repositories for essential documents and data that demonstrate compliance with regulatory requirements and ensure the integrity of trial conduct. Consider factors such as document completeness, data integrity, and regulatory requirements.

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Trials Compliance Clinical Trials Clinical Trials 95

Cloudbyz

APRIL 8, 2024

One of the most significant challenges in conducting clinical trials is ensuring data quality and patient safety while managing costs effectively. Instead of the traditional on-site, source data verification (SDV) method, RBM employs a risk-based, data-driven approach to focus monitoring efforts where they are needed most.

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Clinical Trials Clinical Trials Trials Development 84

XTalks

MAY 9, 2023

Clinical trial manager jobs are vital for the development and execution of clinical trials, which are essential for developing new treatments for diseases. In this article, we discuss the job duties, education and experience requirements, outlook and salary expectations for clinical trial managers.

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Clinical Trials Clinical Trials Trials Clinical Research 98

Drug Discovery World

APRIL 16, 2024

The post Webinar: How to effectively manage collaborations in drug discovery appeared first on Drug Discovery World (DDW). This webinar will be presented by Chris Stumpf, PhD, Directory, Drug Discovery Informatics Solutions, Revvity Signals, as well as Heather Hayes, Signals Synergy Product Leader, Revvity Signals.

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Drugs Production Manufacturing Development 52

Pharmaceutical Technology

JUNE 15, 2023

Product management AI in product management can improve every phase of a product, from ideation to development to commercialization. AI helps unlock meaningful questions in the exploration phase, improves predictive models using sophisticated data science techniques and can even inform product marketing.

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Pharma R&D Production Manufacturing Development 130

Pharma Marketing Network

SEPTEMBER 20, 2023

Pharma companies are highly matrixed organizations, which presents challenges in handoffs, overlaps between roles and functions, access to data and accountability of who owns and acts on this data in a timely manner. Therefore, instigating change at an organizational level is difficult, and takes much longer than anticipated.

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Pharma Companies Marketing 59

Cloudbyz

APRIL 30, 2023

Clinical trials are complex and time-consuming endeavors, requiring efficient management and coordination between various stakeholders. Cloudbyz’s Unified Clinical Trial Management Solution, built on the Salesforce platform, offers a comprehensive, customizable, and secure platform for streamlining clinical trial operations.

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Clinical Trials Clinical Trials Trials Laboratory Information Management System 92

Cloudbyz

MAY 5, 2023

Executive Summary Risk-Based Monitoring (RBM) is an approach to clinical trial monitoring that optimizes the use of resources by focusing on trial risks, with the goal of ensuring patient safety, data quality, and regulatory compliance. Introduction 2.1. Methodology of Risk-Based Monitoring 4.1.

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Clinical Trials Clinical Trials Trials Compliance 85

Cloudbyz

MARCH 1, 2023

Conducting clinical trials requires significant investments of time and resources, including the management of budgets and payments. Historically, the management of budgets and payments in clinical trials has been a paper-based process. Clinical trials are a critical component of drug development in the life sciences industry.

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Clinical Trials Clinical Trials Trials Compliance 94

Pharmaceutical Technology

AUGUST 4, 2022

Soaring patient numbers are stretching hospital capacity across the globe, forcing healthcare providers and their partners to think laterally about how to meet the demand without doubling their resources. Secondary prevention and certain chronic diseases present a particular opportunity to add new value beyond the lab.

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Pharma Companies Branding Production Development 358

Cloudbyz

MARCH 22, 2023

Risk-based monitoring (RBM) is a clinical trial monitoring approach that focuses resources on areas that pose the greatest risk to data quality and patient safety. This can lead to reduced monitoring time and effort, allowing resources to be directed to other aspects of the trial.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Cloudbyz

MARCH 3, 2023

Mid-size Clinical Research Organizations (CROs) play a significant role in the pharmaceutical and biotech industry by providing various services such as study design, clinical trial management, data management, and biostatistics. However, mid-size CROs may lack the regulatory expertise and resources that larger CROs possess.

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Compliance Branding Packaging Packaging 88

Cloudbyz

MAY 11, 2023

Clinical trials play a vital role in bringing new therapies and treatments to patients, but they can be expensive and resource-intensive endeavors. This blog post will delve into the various factors that drive clinical trial costs and provide insights on how to manage and control these expenses effectively.

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Clinical Trials Clinical Trials Trials Compliance 92

ACRP blog

OCTOBER 19, 2023

Research sites play a pivotal role in clinical trials in that they are responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. This makes it difficult to gain the visibility needed to make intelligent, data-driven decisions. This is a sponsored message.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

Drug Discovery World

MARCH 27, 2024

Additionally, sponsors of contracted work struggle with a common set of problems and challenges including: Prioritising and communicating the work to the CRO Onboarding and offboarding CRO resources Tracking the work at the CRO Masking proprietary information from the CRO to preserve the sponsor’s intellectual property Integrating the data from (..)

Drugs 52

Drugs Manufacturing Research Development 52

pharmaphorum

MAY 10, 2022

Roche has elevated a longstanding alliance with Finland’s Kaiku Health focusing on digital patient monitoring and management (DPMM) to the level of a strategic partnership. Results of the pilot in 45 patients with non-small cell lung cancer (NSCLC) treated with Tecentriq with and without chemotherapy were published in 2020.

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Nurses Clinical Trials Clinical Trials Development 137

Advarra

OCTOBER 17, 2023

Research sites play a pivotal role in clinical trials, responsible for participant recruitment, data collection, safety monitoring, regulatory management, overall trial conduct, and more. Financial management tools can help research sites secure the maximum allowable compensation for their services, thereby increasing revenue.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

Scienmag

NOVEMBER 19, 2021

This November, University of Guam will start a $715,014 project that will use unmanned aerial systems (UAS), remote sensing, and NASA technology to closely examine the Northern Guam Lens Aquifer, which supplies 90% of the island’s drinking water, and produce critical data and tools for resource management.

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Research 85

Cloudbyz

FEBRUARY 20, 2024

The healthcare and pharmaceutical industries are increasingly adopting advanced technologies to streamline clinical trial management processes. This can lead to compliance issues, wasted resources, and delays. Its robust data management model, intrinsic to CRM ⇒ Aligns perfectly with the complexities of trial data.

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Clinical Trials Clinical Trials Compliance Trials 52

Cloudbyz

NOVEMBER 14, 2023

In this blog, we will delve into the complexities associated with legacy systems and disconnected data in the context of medical device clinical trials, exploring the challenges they pose and potential solutions to overcome them. Risk to Data Integrity: Disconnected data sources increase the risk of data inconsistencies and inaccuracies.

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Clinical Trials Clinical Trials Trials Compliance 77

pharmaphorum

SEPTEMBER 24, 2020

In the UK, the 1 August step down from EPRR incident level four may have meant we’re no longer in a state of national incident, but at a regional level NHS Trusts and private sector providers are still very much working flat out to manage and contain COVID-19 and its associated fallout. Data at the heart of the post-pandemic world.

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Doctors Doctor Containment Development 110

Advarra

OCTOBER 31, 2023

A phased approach to quality management systems (QMS) ensures quality is embedded at every stage, from discovery to post study. Clinical research is grounded in scientific integrity, participant safety, and data reliability. Clinical research is grounded in scientific integrity, participant safety, and data reliability.

Compliance 52

Compliance Clinical Research Trials Clinical Trials 52

Cloudbyz

MAY 9, 2023

The adoption of Clinical Trial Management Systems (CTMS) by study teams brings numerous benefits, such as streamlined processes, improved efficiency, and better data accuracy. Test the integration thoroughly to ensure data accuracy and integrity are maintained, and communicate any changes in workflows to the study team.

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Clinical Trials Clinical Trials Trials Compliance 88

Cloudbyz

JUNE 16, 2023

They generate a vast amount of valuable data, which needs to be securely archived for future reference and analysis. Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Effectively managing and storing such large datasets presents logistical challenges.

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Clinical Trials Clinical Trials Compliance Trials 77

Worldwide Clinical Trials

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. One such approach is standardizing imaging protocols across your trial sites — consistency is key.

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Trials Clinical Trials Clinical Trials Compliance 183

Rethinking Clinical Trials

OCTOBER 10, 2023

Chat 4 Heart Health will use a patient-level randomized pragmatic trial to test the comparative effectiveness of 3 text messaging delivery strategies that have been shown to improve individuals’ self-management health behaviors, including physical activity and medication adherence. Learn more about TAICHIKNEE.

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Trials Clinical Trials Clinical Trials 141

Drug Discovery World

APRIL 3, 2023

With so many different tasks to keep track of, it’s easy to feel overwhelmed and bogged down by manual data entry, paper-based processes, and transcription errors. Download this free resource. You’ve heard of ELNs, but you may be unfamiliar with how they can help streamline your workflow, increase efficiency, and improve productivity.

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Research Compliance Production Drugs 96

Cloudbyz

SEPTEMBER 14, 2023

The need for Risk-Based Monitoring (RBM) in the realm of Electronic Data Capture (EDC) is paramount as it brings a data-driven and proactive approach to clinical trial oversight. This targeted approach not only reduces the burden on stakeholders but also enhances data quality by focusing on critical data points.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Drug Discovery World

APRIL 23, 2024

The approach defined by the BDDH has two key elements: the evaluation and management of projects by experts in drug discovery and development, and targeted resources to create a diverse, de-risked portfolio of projects that are ready for investment.

Drugs 52

Drugs Clinical Trials Clinical Trials Research 52

Drug Discovery World

APRIL 9, 2024

Additionally, sponsors of contracted work struggle with a common set of problems and challenges including: Prioritising and communicating the work to the CRO Onboarding and offboarding CRO resources Tracking the work at the CRO Masking proprietary information from the CRO to preserve the sponsor’s intellectual property Integrating the data from (..)

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Production Drugs Manufacturing Development 52