ACRP blog

MARCH 7, 2024

Despite this, many sites continue to rely on traditional paper-based methods or in-house digital documentation systems. The adoption of digital document workflows via an electronic investigator site file (eISF) is significant. Beyond this group, the rate of digitization declines significantly, with only approximately 20% of U.S.

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Clinical Trials Clinical Trials Clinical Research Trials 59

Cloudbyz

FEBRUARY 26, 2023

A Trial Master File (TMF) is a comprehensive collection of documentation that provides a complete record of a clinical trial. The TMF contains all essential documents related to the trial, such as study protocols, informed consent forms, investigator brochures, and monitoring reports.

Clinical Trials 80

Clinical Trials Clinical Trials Compliance Trials 80

Pharmaceutical Technology

SEPTEMBER 6, 2022

The growing need for better pharmaceutical logistics, the rising demand for fast-track support, as well as growing adoption of telematics in pharmaceutical logistics are some of the important factors that are expected to drive the pharmaceutical logistics market. Finding the top pharmaceutical logistics and pharma supply chain companies.

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Containment Pharmacy Life Science Production 147

VirTrial

AUGUST 21, 2021

Telemedicine or telehealth solutions may not be new, but virtual video visits are becoming more common for communication between patients and healthcare providers thanks to COVID-19. However, there are few, if any, features that cater to the specific nuances of medical research, such as shared, encrypted calendars and multi-language support.

Clinical Research 97

Clinical Research Research Clinical Trials Clinical Trials 97

Pharmaceutical Technology

OCTOBER 28, 2022

Designed to explain either the risk management plan (RMP) or clinical trial results (CTR) in a way that a child can understand, lay summaries are now a required document for all clinical trials in the European Union (EU) following changes to EU Clinical Trials Regulations (EU-CTR) regulations earlier this year.

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Clinical Trials Clinical Trials Life Science Trials 130

Pharmaceutical Technology

MARCH 3, 2023

During the preparation of validation, the CSCM specialist connects with the BDCM (Business Development Contract Manufacturing) project manager and starts the handover process with a guided protocol, ensuring the completion of project-relevant activities and documents prior to product transfer to the commercial phase.

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Contract Manufacturing Manufacturing Production Marketing 130

Cloudbyz

MAY 14, 2024

Information Risk Register Confirm that risk ratings are documented in an information risk register, with treatment actions approved by stakeholders. Security Management Documented Security Policy Review the vendor’s comprehensive security policy and supporting Acceptable Use Policies (AUPs).

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Compliance Clinical Trials Clinical Trials Regulation 52

Cloudbyz

JUNE 5, 2023

Automating Document Organization: Generative AI-powered algorithms can automatically classify and categorize various documents within an eTMF, eliminating the need for manual sorting and filing. This automation also minimizes human errors and ensures consistent document organization across trials.

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Compliance Clinical Trials Clinical Trials Trials 73

WCG Clinical

NOVEMBER 30, 2023

PRINCETON, NJ, November 30, 2023 – WCG, the global leader in providing solutions that measurably improve and accelerate clinical research, announced today the official launch of IRB+, a groundbreaking service that transforms the landscape of Institutional Review Board (IRB) operations.

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Clinical Trials Clinical Trials Trials Clinical Research 59

Cloudbyz

MARCH 21, 2023

Pharmacovigilance solutions are designed to support these activities and help ensure patient safety. In this blog, we will discuss the must-have business, functional and technical capabilities in a pharmacovigilance solution. It should also have the capability to generate alerts and notifications for further investigation.

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Clinical Trials Clinical Trials Compliance Regulation 52

Rethinking Clinical Trials

DECEMBER 12, 2023

ACP PEACE Reaching ambulatory older adults with educational tools: comparative efficacy and cost of varied outreach modalities in primary care Structural barriers to well-grounded advance care planning for the seriously ill: a qualitative study of clinicians' and administrators' experiences during a pragmatic trial Forms or free-text?

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Trials Clinical Trials Clinical Trials Nurses 143

Pharmaceutical Technology

SEPTEMBER 8, 2022

The companies offer various solid dose products and services including, but not limited to, formulation and analytical development, manufacturing capabilities, technology transfer and scale-up, quality and regulatory support, commercial manufacturing, packaging, and warehousing.

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Manufacturing Marketing Contract Manufacturing Containment 100

XTalks

JANUARY 16, 2024

Caregility , a prominent telehealth solution provider based in New Jersey, has achieved a significant breakthrough in the field with its APS200 Duo and APS100 Pro devices. It supports remote patient observation and can be augmented with the APS FlexCam to further enhance virtual care capabilities.

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Nurses Engineer Development Marketing 59

Rethinking Clinical Trials

FEBRUARY 28, 2024

In a remote study, it would be possible for duplicate enrollment, falsified or fabricated eligibility source documents, or data completed by surrogates. Solutions include a bi-directional EDC (electronic data capture system), MyChart for research, and active notifications to study personnel based on entered data.

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Clinical Trials Clinical Trials Trials Clinical Research 143

Cloudbyz

MAY 9, 2023

Solution: To overcome this challenge, involve study team members in the decision-making process from the beginning. Offer training and support to help them familiarize themselves with the new system and build confidence in using it. Solution: Work closely with IT specialists and system vendors to ensure a smooth integration process.

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Clinical Trials Clinical Trials Trials Compliance 79

Cloudbyz

JUNE 16, 2023

In this blog, we will delve into the overview, purpose, challenges, regulatory requirements, best practices, and digital solutions associated with clinical trial data archiving. Accessibility and Retrieval: The archive system should facilitate easy and timely retrieval of data, supporting queries, and investigations by regulatory authorities.

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Clinical Trials Clinical Trials Compliance Trials 69

Advarra

MAY 25, 2022

Compliant, efficient document management during the various phases of a clinical trial is essential. Yet, throughout a trial, as documents are added to different systems for the investigator/institution and the sponsor, a great deal of time is spent managing those documents; and, of course, as with any manual process, there’s risk of error.

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Compliance Clinical Trials Clinical Trials Trials 52

ACRP blog

OCTOBER 4, 2023

If workflow variation exists between departments, this should be documented clearly for everyone involved. If each moving piece lacks appropriate tracking, you will spend all your time seeking out statuses and documents, rather than focusing on your study start-up role and growing the research program.

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Research Compliance Development 59

ACRP blog

OCTOBER 4, 2023

If workflow variation exists between departments, this should be documented clearly for everyone involved. If each moving piece lacks appropriate tracking, you will spend all your time seeking out statuses and documents, rather than focusing on your study start-up role and growing the research program.

Research 52

Research Compliance Development 52

pharmaphorum

OCTOBER 12, 2022

Facilities can be asked to provide documented records of environmental monitoring, as well as personnel interaction with systems of record and the order in which events occurred. How digital technology can support compliance. Vicki Pearson, Global Solutions Architect, Life Sciences at Schneider Electric. About the author.

Compliance 101

Compliance Manufacturing Life Science Production 101

WCG Clinical

MARCH 30, 2023

WCG’s InvestigatorSpace® offers customizable training solutions to bring accurate and detailed training to life while reducing the time spent on developing assets by an average of 60%. The modules also provided a documented reference guide clinicians could reference at any point in the study to ensure compliance.

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Dermatology Clinical Trials Clinical Trials Trials 52

Intouch Solutions

MAY 26, 2023

But for many, sales tools have amounted to little more than clickable documents, supported by a follow-up email. Marketers need to support that necessary change management and the training required to help reps expand their current view. And you need an agency that can deliver integrated solutions to these challenges.

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Sales Life Science Marketing Production 98

Cloudbyz

MARCH 28, 2023

Cloudbyz specializes in providing cloud-based solutions for the healthcare industry. By leveraging Salesforce’s platform capabilities, Cloudbyz is able to offer a highly customizable and configurable solution that can be tailored to meet the specific needs of each client.

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

Rethinking Clinical Trials

AUGUST 7, 2023

The Implementation Science Core, which launched in 2022, supports implementation-related research aims in pragmatic clinical trials to promote the uptake and sustainability of effective interventions in routine practice. While the Core is still in its early days, the cochairs have plans for how to best serve the NIH Collaboratory. .

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Trials Clinical Trials Clinical Trials Development 130

Rethinking Clinical Trials

OCTOBER 2, 2023

Over the last decade, collection of guidance documents and resources have been developed to develop each of the steps in the clinical trial directory. The PROTEUS-Practice Guide offers support for designing, implementing, and managing PRO systems in clinical care.

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Clinical Trials Clinical Trials Research Trials 154

XTalks

JANUARY 9, 2024

Members of the Atropos Evidence Network have the opportunity to contribute data and leverage Atropos Health’s solutions to extract insights from a vast pool of over 160 million de-identified patient records spanning the globe. This platform, designed to deliver evidence-based CDS, gets 1.7 CareCloud, Inc.,

Life Science 59

Life Science Clinical Trials Clinical Trials Trials 59

Advarra

SEPTEMBER 14, 2023

A common challenge for many clinical trial stakeholders involves maintaining adequate GxP documentation – without this, it can result in fines and sanctions. In order to do so, this requires thorough implementation of several GxP best practices: documentation, communication, traceability, and accountability.

Clinical Research 52

Clinical Research Compliance Research Regulation 52

pharmaphorum

MAY 16, 2022

In 2020, USAID launched two policy documents to guide how the agency invests in digital infrastructure as part of its development and humanitarian assistance programmes: Digital Strategy and Vision for Action in Digital Health (aka Digital Health Vision). About the interviewee. The Future of Information-Sharing in Humanitarian Emergencies.

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Development Life Science Vaccination Vaccine 113

Cloudbyz

FEBRUARY 29, 2024

By automating data extraction processes, AI minimizes the risk of human error and ensures consistency in capturing critical data points across various documents. Cloudbyz clinExtract AI is a transformative solution that elevates data extraction in clinical research.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

Advarra

JULY 19, 2022

For research sites whose communities include large populations of non-English speakers, it may be standard operating procedure (SOP) to obtain a translated version(s) of the study’s informed consent document at the beginning of each study. Documentation requirements still must be followed as well.

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Research Regulation Trials Compliance 52

Drug Discovery World

MARCH 4, 2024

Additionally, assay analysis aids in understanding structure-activity relationships, optimising dose-response relationships, and supporting regulatory compliance and intellectual property claims. Reproducibility suffers because assay protocols are not sufficiently documented, so that different team members run them with slight variation.

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Drugs Bioassay Scientist In-Vivo 59

Cloudbyz

FEBRUARY 29, 2024

By automating data extraction processes, AI minimizes the risk of human error and ensures consistency in capturing critical data points across various documents. Cloudbyz clinExtract AI is a transformative solution that elevates data extraction in clinical research.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

WCG Clinical

JANUARY 12, 2024

For example, the skills that are necessary to identify and pre-screen potential participants are different from those required for data entry and documentation. Balancing study responsibilities requires a systematic and realistic approach, often necessitating additional resources or support systems to manage trial operations.

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Clinical Trials Clinical Trials Trials Clinical Research 52

ACRP blog

AUGUST 2, 2023

Document, simplify, and standardize workflows and processes that are conducted regularly. WCG partners with research sites to provide comprehensive, integrated solutions designed to address the primary challenges sites face in effectively launching, managing, and growing a research program.

Trials 52

Trials Clinical Research Clinical Trials Clinical Trials 52

ACRP blog

AUGUST 2, 2023

Document, simplify, and standardize workflows and processes that are conducted regularly. WCG partners with research sites to provide comprehensive, integrated solutions designed to address the primary challenges sites face in effectively launching, managing, and growing a research program.

Trials 52

Trials Clinical Research Clinical Trials Clinical Trials 52

Cloudbyz

FEBRUARY 20, 2024

High maintenance costs: Frequent updates, patches, and vendor support can significantly inflate the total cost of ownership for legacy systems. Where does Salesforce comes in this picture : Salesforce, a leader in the CRM world, surprisingly emerges as a formidable solution for clinical trials.

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Clinical Trials Clinical Trials Compliance Trials 52

Clinical Trial Podcast

FEBRUARY 23, 2021

The start-up packet consists of the protocol, ICF template, and other study specific documents. This means that in-house operation is constantly inundated with multiple documents and redlines. CRA’s life revolves site management and support. The in-house operations team is available for site management and support.

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Clinical Research Research Clinical Trials Clinical Trials 105