Compliance
PRODUCTS
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Meet FDA guidelines for GMP in tablet and capsule production with a secure, failsafe system. Qualification reports are available.
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Electronic informed consent for patient-centric decentralized clinical trials.
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Ergomed’s Risk-Based Clinical Monitoring and Source Data Verification Approach for Data Integrity
Ergomed ensures the highest data integrity and patient safety standards through our risk-based clinical monitoring and Source Data Verification (SDV) practices. SDV is a critical process in clinical trials that ensures the data collected are accurate, complete, and verifiable against the source documents. We compare data entered into case report forms or electronic data capture systems with the source data to confirm their accuracy and reliability.
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The most widely trusted solution for clinical trial disclosure management
Managing clinical trial disclosures can be tedious and error-prone, opening the door to noncompliance. TrialScope Disclose provides a better way.
Our centralized platform automates data entry and reporting for Clinicaltrials.gov, CTIS, and more. This reduces manual effort so you can focus on bringing new treatments to patients, not paperwork.
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The SamuxMP Auto is the automated mass photometer for AAV characterization, autonomously measuring up to 24 samples in approximately 90 minutes. The instrument rapidly measures AAV empty/full ratios, sample purity and particle aggregation for any AAV serotype – with high precision and reproducibility.
WHITE PAPERS AND CASE STUDIES
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Demanding More From AI Governance In Drug Safety
Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.
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Case Study: Commercial Metals Company Centralizes AP Processes And Save 55,000 A Year With ImageSilo® When the Director of Shared Services at Commercial Metals Company (CMC) was asked to centralize the accounts payable processes of 40 metal recycling yards scattered across the country, he quickly realized that paper documents were the roots of his AP problems at the yards. By Digitech Systems, Inc.
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Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot
Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research efficiency.
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Phoenix Children's Hospital Improves Service And Timely Revenue With Verisma's Release Of Information Technology And Expert Support
Since the hospital’s founding in 1983, Phoenix Children’s Hospital (PCH) has provided hope, healing, and the best health care for children across Arizona. Over 80 percent of pediatric subspecialists in the metropolitan area and 50 percent of pediatricians in Maricopa County are associated with PCH’s ambulatory and acute care network.
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How Social Technologies Are Creating A New Paradigm For Addressing Business Objectives
This case study investigates how Within3 supported a culture of innovation by introducing three pharmaceutical companies to secure, regulatory-compliant virtual advisory boards. By Within3
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Validation Provider Shortens The Path To Equipment Qualification
Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.
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Comparative Analysis For Non-IND Sites
A cancer research organization that facilitates multi-national clinical trials was in the planning and coordination of a Phase III drug trial and wanted to expand the trial to include German sites. Conducted under an IND, the trial was going according to plan until German regulations changed.
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Focus On Your Core Business Strategy
Learn how a large manufacturing client helped to focus on their core business with a solution that transitioned approximately 60% of the workforce and capitalized on the initial training investment.
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Case Study: Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
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California agencies find private staffing effective If you took a straw poll among public agencies, chances are you would find that a large percentage of them are now using private staffing...
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PCI Compliance: Keep Your Customers And Business Secure The PCI DSS provides steps to protect organizations, customers, and the card processing system from fraud. The steps include requirements for security management, payment policies, data storage procedures, network architecture, software design, and other payment system measures. Submitted by Heartland
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Support Manufacturing Operations With Process Data Management Software
Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).
NEWS
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SignWell Launches NOM-151 Compliant E-Signatures In Mexico12/9/2025
Businesses across Mexico now have a more straightforward, more affordable way to sign documents online legally. SignWell, a leading e-signature platform trusted by over 65,000 businesses globally, is now officially offering NOM-151-compliant electronic signatures, ensuring legal validity under Mexican regulations.
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Anritsu Supports EU Market Expansion By Ensuring Safety And Compliance Of 5G Wireless Devices10/21/2025
Anritsu Corporation has enhanced the functions of its New Radio RF Conformance Test System ME7873NR to support 5G wireless device conformance tests and compliance with the ETSI*1 EN 301 908-25 standard under the European Radio Equipment Directive (RED).
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Rise Expands Employer Of Record Services To Revolutionize Global Hiring And Payroll Compliance4/3/2025
Rise, the pioneering Web3-enabled payroll and compliance platform, has announced the expansion of its Employer of Record (EOR) services, enabling businesses to seamlessly hire full-time employees across borders without the need to establish local entities.
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Oncotelic Therapeutics Announces Strategic Partnership With TechForce Robotics To Commercialize PDAOAI-Enhanced GMP Robotics Platform4/2/2026
Oncotelic Therapeutics, Inc. (“Oncotelic” or the “Company”), a clinical-stage biotechnology company focused on oncology and AI-driven solutions, today announced that it has entered into a strategic partnership with TechForce Robotics, Inc. (“TechForce”) to advance the commercialization of its PDAOAI-enabled, GMP-compliant robotics platform.
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SwiftComply Launches Next-Gen Pretreatment Module, Setting A New Standard For Water Compliance6/18/2025
SwiftComply, the software platform built specifically for water utility compliance, today announced the launch of its new Pretreatment module, a specialized, smart system for managing industrial wastewater oversight.