Pharmaceutical compliance management software for the pharmaceutical industry
Pharmaceutical Technology
APRIL 19, 2024
Pharmaceutical Compliance Management Software Is Designed to Enhance Patient Safety. Download the Free Buyer’s Guide Here.
compliance-management Compliance Related Topics 
Pharma waste management: Balancing cost, compliance, and environmental responsibility
pharmaphorum
JANUARY 22, 2024
Pharma waste management is crucial for balancing cost, compliance, and environmental responsibility in the healthcare industry. Explore strategies and best practices for effectively managing pharmaceutical waste, while ensuring regulatory compliance and minimising environmental impact.
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Pfizer faces whistleblower lawsuit from former compliance manager who says he flagged possible fraud in China
Fierce Pharma
AUGUST 10, 2023
After Pfizer allegedly fired a compliance manager for raising the flag on potential fraud activity in China, the former employee is hitting back. Frank Han, Pfizer's former director of global compliance analytics, has filed a civil complaint against the drugmaker.
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Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management
ProRelix Research
DECEMBER 28, 2023
Considering the crucial role that the information generated from clinical trials play in the approval of new drugs, biological, and medical devices, it is only logical that the data garnered […] The post Clinical Data Standardization in Clinical Trials: FDA Compliance in Clinical Data Management appeared first on ProRelix Research.
Clinical Trial Data Management Audit Checklist and Best Practices: Ensuring Data Integrity and Compliance
Cloudbyz
MAY 24, 2023
In order to ensure the reliability and validity of the data collected during these trials, rigorous data management practices and audits are necessary. In this blog, we will explore the essential components of a clinical trial data management audit checklist and discuss best practices for conducting successful audits.
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Is Apple that naive when it comes to compliance?
World of DTC Marketing
SEPTEMBER 12, 2022
The Health app adds Medications, allowing users to conveniently build and manage a medications list, create schedules and reminders, and track their medications, vitamins, or supplements. The post Is Apple that naive when it comes to compliance? Apple’s Health app gets new capabilities with iOS 16. Will it matter?
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What is Going on in Billing Compliance for Clinical Trials?
ACRP blog
JUNE 30, 2023
Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. She concluded that “a proactive approach to clinical trial billing compliance can help mitigate these risks.”
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Join HCCA for the 28th Annual Compliance Institute
ACRP blog
JANUARY 8, 2024
Few industries have a need to understand the complexities of compliance more than clinical research. The importance of compliance in clinical research cannot be stressed enough. This year’s Compliance Institute features more than 100 educational sessions across 14 unique learning tracks. This is a sponsored message.
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Why is Research Compliance Important and Where Can I Learn More?
ACRP blog
FEBRUARY 28, 2024
To get the latest information and insights on a broad spectrum of topics, Health Care Compliance Association® (HCCA®) invites you to join us for our 28th Annual Compliance Institute , April 14–17. The city of Nashville, Tenn., Those who attend the virtual conference option can network with an anticipated 1,000 virtual attendees.
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The criticality of compliance
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.
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The Transformative Power of Generative AI in eTMF: Enhancing Efficiency, Quality, and Compliance
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.
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HPMers to Slated to Speak at FDLI’s Enforcement, Litigation and Compliance Conference
FDA Law Blog
NOVEMBER 30, 2023
The 2023 Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation and Compliance Conference will boast two speakers from Hyman, Phelps & McNamara, P.C. (“HPM”), The conference will also include its annual panel discussion with FDA’s Center Compliance Directors. Blumberg Memorial Lecture. next week, on December 6-7, 2023.
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ICON Launches FIRECREST Safety Letters and Site Question Management Supporting Regulatory Compliance and Increasing Site Support
BioTech 365
FEBRUARY 8, 2021
ICON Launches FIRECREST Safety Letters and Site Question Management Supporting Regulatory Compliance and Increasing Site Support ICON Launches FIRECREST Safety Letters and Site Question Management Supporting Regulatory Compliance and Increasing Site Support New solutions enable enhanced delivery, tracking and management … Continue reading → (..)
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Mastering 21 CFR Part 11 Compliance: A Comprehensive Guide for Clinical Trials in the Digital Age
Cloudbyz
JUNE 10, 2023
21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Food and Drug Administration (FDA).
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The Compliance and Clinical Research Connection
ACRP blog
JANUARY 11, 2023
Compliance can feel like a mild distraction at best, or a mass of red tape that slows forward progress. Health Care Compliance Association® (HCCA®) was established to do just that. As a nationally recognized association, HCCA is the authority on healthcare compliance and ethics, so you don’t have to be.
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Global Managed Equipment Services (MES) & Enterprise Compliance and Quality Management (ECQM) Market (2021 to 2029) – Featuring GE Healthcare, SAP and Pilgrim Software Among Others – ResearchAndMarkets.com
BioTech 365
JUNE 15, 2021
Global Managed Equipment Services (MES) & Enterprise Compliance and Quality Management (ECQM) Market (2021 to 2029) – Featuring GE Healthcare, SAP and Pilgrim Software Among Others – ResearchAndMarkets.com Global Managed Equipment Services (MES) & Enterprise Compliance and Quality Management (ECQM) … Continue reading → (..)
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Life sciences promotional content management for speed, compliance and insight
pharmaphorum
APRIL 27, 2017
The life sciences landscape is moving at a rapid pace, which in turn is increasing the demands on marketers to create innovative, digital content faster while maintaining industry compliance. Veeva Systems recently conducted an annual industry study, focused on content and digital asset management within life sciences.
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A Message to Pharma CIOs: Optimizing Salesforce Improves Security and Compliance
pharmaphorum
FEBRUARY 4, 2021
Salesforce org management is usually not the headliner for CIOs and CTOs looking to catch up on executive-level trends and issues pertaining to technology. However, issues like compliance, governance and security often are. The result; costly problems that could have been avoided with proper Salesforce org management. .
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Clinical Trial Data Archiving: Ensuring Efficiency, Compliance, and Accessibility
Cloudbyz
JUNE 16, 2023
Effective clinical trial data archiving is essential to ensure data integrity, regulatory compliance, and seamless access. Overview: Clinical trial data archiving involves the systematic storage, management, and retrieval of data collected during the course of a clinical trial.
A Comprehensive Guide to Pharmacovigilance Regulatory Reporting: Ensuring Patient Safety and Compliance
Cloudbyz
APRIL 25, 2023
This comprehensive guide delves into the essentials of pharmacovigilance regulatory reporting, highlighting its significance in maintaining drug and device safety, and ensuring compliance with regulatory requirements. Risk Management Plan (RMP): An RMP is a comprehensive document outlining the risk management system for a drug or device.
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Navigating CAPA in Clinical Development: Ensuring Compliance and Quality Assurance
Advarra
OCTOBER 4, 2023
When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.
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What is Going on in Billing Compliance for Clinical Trials?
ACRP blog
JUNE 30, 2023
Clinical trial billing compliance—ensuring that charges for therapies and other study-related elements are sent to the appropriate party—is a key concern for academic medical centers and other research organizations. She concluded that “a proactive approach to clinical trial billing compliance can help mitigate these risks.”
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52 Indian pharma & healthcare sectors encounter supply chain issues
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 4, 2023
Indian pharma & healthcare faces numerous challenges in the supply chain, such as lack of visibility to the recipients and the shippers, maintaining the integrity and safety of temperature-sensitive products, meeting regulatory compliance requirements, and managing logistics costs while ensuring timely delivery.
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Enhancing Electronic Trial Master File (eTMF) Quality Oversight with a Risk-Based Approach
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. Risk Prioritization: Prioritize risks based on their impact on trial integrity and compliance.
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Learn how the Cloudbyz Vet eClinical Platform aligns with the latest FDA guidelines
Cloudbyz
MAY 15, 2024
The Cloudbyz eClinical platform, comprising CTMS, eTMF, EDC and Safety & Pharmacovigilance, can significantly enhance compliance with these guidelines. Study Setup and Planning: Cloudbyz CTMS can manage and streamline the entire study setup process, ensuring adherence to FDA guidelines on pharmaceutical development.
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How the New EU AI Act Will Impact Clinical Trials in the Life Sciences?
Cloudbyz
MAY 17, 2024
These systems must undergo thorough conformity assessments to verify their compliance with safety, transparency, and accountability standards, thereby boosting the reliability and integrity of clinical trial data. Companies will need to adeptly navigate these regulations to balance innovation with compliance.
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FSMA 204: FDA Introduces New Tools for Food Traceability Rule Compliance
XTalks
DECEMBER 7, 2023
These tools are designed to assist stakeholders in achieving compliance before the deadline of January 20, 2026. This growing participation reflects a proactive approach by companies across the food supply chain to achieve compliance well before the FDA’s January 2026 deadline.
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Optimizing Data Collection in Post-Surgical Pain Studies & The Role of Clinical Assessments
Worldwide Clinical Trials
APRIL 25, 2024
Authors: Rolana Avrumson, MS, VP Clinical Projects, Clinical Assessment Technologies; Barry Dussault Executive Director, Project Management, Franchise Area Lead, Pain Upwards of 58% of patients experience moderate to severe post-surgical pain, while some research places that figure even higher at a staggering 80%.
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Buyer Checklist for Security Assessment of eClinical Vendors
Cloudbyz
MAY 14, 2024
With the rise of eClinical systems, the management of clinical trials has become more efficient and data-driven. Information Security Assurance Program Confirm the existence of a well-defined Information Security Management System (ISMS) that is certified to ISO 27001:2013 standards. and confirm that relevant employees are certified.
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Buyer’s Checklist For Selecting The Right eSource Vendor
Cloudbyz
MAY 15, 2024
An eSource system not only facilitates the electronic collection and management of clinical trial data but also ensures compliance with regulatory standards, enhances participant management, and optimizes data integrity and reporting processes.
Anne Walsh to Moderate FDLI Compliance and Enforcement Panel
FDA Law Blog
DECEMBER 2, 2021
s Anne Walsh will be moderating “Updates in Litigation Risks: Product Liability, Private Litigation, and Consumer Class Actions,” at the upcoming Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 9-10. Hyman, Phelps & McNamara, P.C.’s
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Streamlining Clinical Trials: Common Workflow Automations in Electronic Trial Master File (eTMF) Systems
Cloudbyz
OCTOBER 30, 2023
Clinical trials are vital for advancing medical research, but they involve complex processes and a multitude of documents that need careful management and oversight. The Electronic Trial Master File (eTMF) system is a cornerstone of clinical trial document management, providing a digital repository for essential trial documents.
Unlocking Efficiency in Clinical Trials: How AI is Revolutionizing Data Management
Cloudbyz
MARCH 22, 2024
In the realm of clinical research, the efficient management of data is paramount. However, traditional methods of data entry, particularly from diverse and unstructured documents, have long posed challenges for researchers, leading to inefficiencies, errors, and compliance risks.
How to address 21 CFR Part 11 compliance requirements when considering ChatGPT in Clinical Trial Operations
Cloudbyz
APRIL 14, 2023
To ensure that the implementation of ChatGPT in clinical trial operations management complies with 21 CFR Part 11 requirements, the following steps should be taken: Validation: Validate the ChatGPT system and any software that interacts with it to ensure its accuracy, reliability, and consistent intended performance.
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The Challenges of Adopting Decentralized Clinical Trial Platforms
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. This includes secure communication channels, data storage and management systems, and tools for patient engagement and monitoring.
Sharps Compliance Corp. Announces Proposed Public Offering of Common Stock
BioTech 365
AUGUST 25, 2021
Sharps Compliance Corp. Announces Proposed Public Offering of Common Stock Sharps Compliance Corp. 25, 2021 (GLOBE NEWSWIRE) — Sharps Compliance Corp. Nasdaq: SMED), a full service provider of waste management, today … Continue reading → Announces Proposed Public Offering of Common Stock HOUSTON, Aug.
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As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever
pharmaphorum
JULY 21, 2022
With attention and resources focused elsewhere during the pandemic, it’s likely that many facilities may have slipped into a state of non-compliance, which may result in unsuccessful inspections. Doing so means that businesses can check their compliance before an FDA inspection. She has a Ph.D.
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Experts to come together for compliance event ‘validation ready’ global labeling systems
pharmaphorum
APRIL 28, 2021
Experts to come together for compliance event . A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labeling risk. Pictured above: Phil Dray, Test Manager at PRISYM ID. exploring ‘validation ready’ global labeling systems . ? .
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Unleashing the Synergistic Power of CRO-eClinical Partnerships
Cloudbyz
JANUARY 31, 2024
CROs, with their specialized expertise in protocol design, patient recruitment, and regulatory compliance, offer invaluable support. eClinical companies, armed with advanced data management solutions and cutting-edge technologies, provide the tools and insights needed for efficient trial execution.
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Informa Connect’s Compliance Congress for Specialty Products
Drug Channels
APRIL 19, 2021
Informa Connect’s Compliance Congress for Specialty Products. June 22-24, 2021 | Virtual Event www.informaconnect.com/specialty-compliance/. Up your compliance game at this important event serving the unique sector of Specialty Products, the 7th annual Virtual Compliance Congress for Specialty Products.
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Buyer’s Checklist for Selecting the Right eTMF Vendor
Cloudbyz
MAY 17, 2024
When choosing an Electronic Trial Master File (eTMF) system for your clinical trials, it’s crucial to ensure the system not only meets your organizational needs but also complies with regulatory requirements and enhances operational efficiency.
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7 Benefits of integrating EDC with CTMS, eTMF and Safety
Cloudbyz
MARCH 9, 2023
Integrating electronic data capture (EDC) with other clinical trial management systems like clinical trial management systems (CTMS), electronic trial master files (eTMF), and safety systems can offer numerous benefits to pharmaceutical companies, contract research organizations (CROs), and academic research institutions.
Unpacking The Role of a Right-Sized QMS in Study Startup
Advarra
NOVEMBER 9, 2023
A key component in streamlining these activities is an effective quality management system (QMS). This helps each site follow consistent procedures, which reduces the risk of errors, omissions, or delays in meeting study milestones due to regulatory non-compliance. This guarantees consistency and compliance.
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Introduction to Coverage Analysis with Kelly Willenberg
Clinical Trial Podcast
APRIL 30, 2022
Prior to starting her firm in 2009, Kelly worked for over 12 years at Vanderbilt University Medical Center where she established the enterprise wide billing compliance program and served as the first Director of Billing Compliance. She has a bi-monthly column in Compliance Today titled “Research Reflections”.
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