Cloudbyz

JUNE 5, 2023

In the fast-paced world of clinical research, managing essential Trial Master Files (TMFs) efficiently, while ensuring quality and compliance, is paramount. In this blog, we will explore how generative AI can revolutionize electronic Trial Master File (eTMF) management, unlocking new levels of efficiency, quality, and compliance.

Compliance 82

Compliance Clinical Trials Clinical Trials Trials 82

Pharmaceutical Technology

SEPTEMBER 5, 2022

Wholesale distributors are responsible for guaranteeing product quality and preventing the influx of counterfeited drugs. Temperature control facilities and supply solutions. Quality in terms of number of defective items, packaging and labelling, quality management system certification, research, development, and innovation.

Packaging 130

Packaging Packaging Compliance Manufacturing 130

Cloudbyz

OCTOBER 30, 2023

Understanding the Electronic Trial Master File (eTMF) System An eTMF system is a software solution designed to organize, store, and manage the documentation associated with a clinical trial. eTMF systems facilitate document collection, organization, and retrieval while ensuring regulatory compliance.

Clinical Trials 100

Clinical Trials Clinical Trials Trials Compliance 100

Cloudbyz

SEPTEMBER 28, 2023

Researchers and clinical trial professionals are constantly seeking innovative solutions to streamline the data collection process, improve data quality, and enhance overall efficiency. This integration not only saves time and resources but also ensures the highest standards of data quality and accuracy.

Life Science 107

Life Science Clinical Research Clinical Trials Clinical Trials 107

Cloudbyz

APRIL 17, 2024

Some of which are listed below: Regulatory and compliance challenges: One of the biggest challenges in the adoption of DCT platforms is the regulatory and compliance landscape. Cloudbyz Unified Clinical Trial Management (CTMS) is a comprehensive, integrated solution to streamline clinical trial operations.

Clinical Trials 72

Clinical Trials Clinical Trials Trials Compliance 72

Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. The core objective of the collaboration is to make the therapies affordable and accessible to patients.

Gene Therapy 130

Gene Therapy Gene Development Antibody 130

Cloudbyz

MARCH 31, 2024

At the heart of this change is a move away from traditional point systems—discrete tools designed for specific tasks within a trial—to comprehensive platform solutions that offer a unified approach to managing all aspects of a trial. The Platform Approach: A Comprehensive Solution 1.

Clinical Trials 89

Clinical Trials Clinical Trials Trials Compliance 89

Cloudbyz

MARCH 17, 2024

Salesforce ‘s Life Sciences Cloud: Transforming Research and Development Salesforce, a leader in cloud-based customer relationship management (CRM) solutions, has unveiled its dedicated Life Sciences Cloud, tailored specifically to meet the complex needs of the industry.

Life Science 77

Life Science Clinical Trials Clinical Trials Trials 77

Pharmaceutical Technology

SEPTEMBER 7, 2022

The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision. The download contains detailed information on the providers and their services and solutions, alongside contact details to aid your purchasing decision. Patient adherence.

Pharmacy 130

Pharmacy Containment Manufacturing Compliance 130

Cloudbyz

NOVEMBER 14, 2023

Clinical trials play a pivotal role in bringing new medical devices to market, ensuring their safety, efficacy, and compliance with regulatory standards. Compliance Issues: Legacy systems may not meet current regulatory requirements and compliance standards, posing significant risks to the accuracy and integrity of trial data.

Clinical Trials 77

Clinical Trials Clinical Trials Trials Compliance 77

pharmaphorum

OCTOBER 12, 2022

Prior to selling drugs or medical products in any country, pharmaceutical companies must prove compliance and gain the regulatory approval required by the country in which the goods will be distributed in. So, with mandates in place, how do manufacturing facilities meet these compliance goals? The dominion of data.

Compliance 104

Compliance Manufacturing Life Science Production 104

Cloudbyz

APRIL 16, 2023

Clinical Trial Management Systems (CTMS) and payments solutions are software platforms designed to streamline the management and administration of clinical trials. In this blog, we will discuss the top five reasons why a site should use a CTMS and payments solution.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Worldwide Clinical Trials

AUGUST 15, 2023

At Worldwide, we understand the significance of this collaboration and are dedicated to becoming an extension of your team, providing personalized clinical development solutions that align with your corporate objectives and milestones. Here’s why Worldwide is the ideal partner for your biotech growth journey: 1.

Clinical Development 246

Clinical Development Development Compliance Trials 246

Cloudbyz

APRIL 9, 2024

Medical devices are subject to a range of regulations, both nationally and internationally, and compliance with these regulations can be difficult and time-consuming. Cloudbyz Unified Clinical Trial Management (CTMS) is a comprehensive, integrated solution to streamline clinical trial operations.

Clinical Trials 72

Clinical Trials Clinical Trials Compliance Trials 72

Cloudbyz

FEBRUARY 29, 2024

Rapid Identification of Safety Signals : Timely detection of safety signals is imperative for ensuring patient safety and regulatory compliance in clinical trials. Optimization of Regulatory Reporting : Compliance with regulatory requirements is a cornerstone of pharmacovigilance activities in clinical trials.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

Drug Discovery World

FEBRUARY 1, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance , which is supported by Thermo Fisher Scientific. The post Webinar: Enhancing quality control in biotherapy manufacturing appeared first on Drug Discovery World (DDW).

Manufacturing 52

Manufacturing Genotype Gene Therapy Compliance 52

Cloudbyz

JULY 12, 2023

Welcome to our cutting-edge Real World Evidence (RWE) solution, harnessing the capabilities of the Salesforce platform. Our RWE Solution on the Salesforce Platform: Streamlined Data Integration: Our RWE solution seamlessly integrates with diverse data sources, harmonizing and consolidating information into a unified format.

Compliance 90

Compliance Clinical Trials Clinical Trials Research 90

Cloudbyz

SEPTEMBER 14, 2023

This targeted approach not only reduces the burden on stakeholders but also enhances data quality by focusing on critical data points. As the regulatory landscape evolves, RBM aligns trials with compliance requirements, reducing the risk of delays in approval processes and enhancing the credibility of trial results.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Cloudbyz

NOVEMBER 1, 2023

Regulatory Compliance: Numerous regulatory authorities worldwide, including the U.S. Compliance with these regulations is non-negotiable, and MedDRA integration is the means to achieve it. Improved Data Quality: By reducing data errors, inconsistencies, and ambiguities, MedDRA integration contributes to higher data quality.

Compliance 94

Compliance Drugs Production Regulation 94

XTalks

JANUARY 22, 2024

Healthmine’s Unique Approach Distinctively, Healthmine is the only tech company in the market that combines expert healthcare consulting with solutions for member engagement and experience. This innovative strategy allows health plans to adeptly manage impending regulatory changes that could impact quality, risk assessments and revenue.

Compliance 59

Compliance Marketing Development 59

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. They also aim to ensure medical devices created through the use of AI/ML are secure, efficient, and maintain a high level of quality.

Clinical Research 52

Clinical Research Compliance Research Clinical Trials 52

Cloudbyz

FEBRUARY 29, 2024

Rapid Identification of Safety Signals : Timely detection of safety signals is imperative for ensuring patient safety and regulatory compliance in clinical trials. Optimization of Regulatory Reporting : Compliance with regulatory requirements is a cornerstone of pharmacovigilance activities in clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

Drug Discovery World

FEBRUARY 1, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance, which is supported by Thermo Fisher Scientific. Specifically, leveraging the Applied Biosystems MicroSEQ Microbial Identification System in biotherapeutic manufacturing.

Manufacturing 52

Manufacturing Genotype Gene Therapy Compliance 52

Drug Discovery World

FEBRUARY 22, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance , which is supported by Thermo Fisher Scientific. Specifically, leveraging the Applied Biosystems MicroSEQ Microbial Identification System in biotherapeutic manufacturing.

Production 52

Production Genotype Manufacturing Gene Therapy 52

Cloudbyz

JUNE 16, 2023

Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. In this blog, we will delve into the overview, purpose, challenges, regulatory requirements, best practices, and digital solutions associated with clinical trial data archiving.

Clinical Trials 77

Clinical Trials Clinical Trials Compliance Trials 77

Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Finding the best commercial packaging suppliers in contract marketing. Pharmaceutical packaging formats and materials. Trends in pharmaceutical contract packaging.

Packaging 130

Packaging Packaging Marketing Containment 130

Drug Discovery World

FEBRUARY 15, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance , which is supported by Thermo Fisher Scientific. Specifically, leveraging the Applied Biosystems MicroSEQ Microbial Identification System in biotherapeutic manufacturing.

Production 52

Production Genotype Manufacturing Gene Therapy 52

Drug Discovery World

FEBRUARY 8, 2024

Join DDW for this free event, Implementing rapid microbial identification in biotherapy manufacturing: Enhancing quality control and regulatory compliance , which is supported by Thermo Fisher Scientific. The event will take place on 26 February 3 pm GMT / 4 pm CET / 10 am EST / 7 am PST.

Manufacturing 52

Manufacturing Genotype Gene Therapy Compliance 52

Cloudbyz

MARCH 13, 2023

Ensure Quality Control: Quality control processes should be in place to ensure the accuracy and completeness of the data. Ensure Compliance with Regulations and Guidelines: Clinical trial data management should be in compliance with regulatory requirements and industry standards.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

VirTrial

FEBRUARY 12, 2024

Clinical trials continue to become more complex and whilst there is extensive evidence demonstrating the improvement of data quality through electronic collection of Clinical Outcomes Assessment (eCOA) data, trial complexity can place additional burden on clinical research sites.

Trials 52

Trials Clinical Trials Clinical Trials Clinical Research 52

Cloudbyz

FEBRUARY 20, 2024

This can lead to compliance issues, wasted resources, and delays. Limited data security: Outdated security protocols may not meet current data privacy regulations, increasing the risk of breaches and non-compliance. Here are the top 10 reasons why a Salesforce-based CTMS solution stands out: 1.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

Cloudbyz

NOVEMBER 9, 2021

an innovative digital solutions provider for organizations that specialize in Clinical Research, Life Sciences, and Biopharmacy, announces receiving the ISO 9001:2015 certification. ISO 9001:2015 is a globally recognized quality standard developed and published by the International Organization for Standardization (ISO).

Life Science 52

Life Science Clinical Trials Clinical Trials Clinical Research 52

WCG Clinical

AUGUST 22, 2023

PRINCETON, NJ, August 22, 2023: WCG, the global leader in providing solutions that measurably improve the quality, efficiency, and safety of clinical research, today announces the WCG MAGI Clinical Research Conference, an educational mainstay for clinical trial professionals for more than 15 years, is going virtual for its fall 2023 event.

Clinical Research 52

Clinical Research Research Compliance Clinical Trials 52

Cloudbyz

MARCH 6, 2023

Such a platform would provide a centralized location for all stakeholders to access and share important information, such as study protocols, patient data, and regulatory compliance documents. This integration can reduce data entry errors and enhance data quality.

Clinical Trials 52

Clinical Trials Clinical Trials Compliance Trials 52

Cloudbyz

FEBRUARY 21, 2023

Regulatory agencies, such as the FDA or EMA, may inspect the TMF as part of their oversight of clinical trials to ensure compliance with applicable regulations and guidelines. The agency may also review the TMF to assess the quality of the trial’s data and the validity of the trial’s results.

Clinical Trials 94

Clinical Trials Clinical Trials Trials Compliance 94

pharmaphorum

MARCH 2, 2021

The aim is to get quality clinical products to the market faster. So efficiency, compliance, and patient care have been compromised. The industry is now recognizing that to stay ahead of competitors, technological cloud-based clinical trial software solutions are key for faster, more efficient clinical trials. High data quality.

Clinical Trials 115

Clinical Trials Clinical Trials Trials Compliance 115

Drug Discovery World

DECEMBER 28, 2022

The new kits enable high quality data to be generated through well characterised kit reagents and standards, and cover the full spectrum of cytokine levels seen in disease states or pharmacodynamic studies. . Scipio bioscience’s single-cell RNA-seq solution includes the Asteria Benchtop Kit and the Cytonaut Cloud Analysis Software. .

Production 97

Production Reagent Drugs Life Science 97