Compliance
PRODUCTS
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The AES modular cleanroom system is engineered with inherent flexibility to seamlessly incorporate essential modular cleanroom accessories while maintaining structural integrity and eliminating the need for costly engineering rework.
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Implement Software Solutions that Support and Enhance Your Mission
Whether you’re heading toward clinical trials or on the path to commercialization, implement technology infrastructure that keeps pace. The last thing you need in a fast-moving industry is for your business management solutions to lag behind.
As a leading life science technology consultant, we can help you streamline operations and ensure compliance, allowing stakeholders to do what they do best: develop new medicines for patients who need them. Sikich has helped over 250 Life Sciences companies grow from pre-revenue to commercialization quickly and painlessly.
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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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Manage inspection-ready clinical trial documents with confidence for faster study execution with TrialKit’s electronic trial master file system.
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Gain expert guidance and connect with a global network of qualified QPPVs and LPPVs, who will ensure compliance with pharmacovigilance regulations and tailor their approach to your product launch strategy.
WHITE PAPERS AND CASE STUDIES
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Regulatory Compliance: Weighing In Pharma Manufacturing
Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.
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Isn't The RFID Bandwagon Full? The RFID (radio frequency identification) space is a confusing market, and industry experts are not making it any more clear. Used with permission from Integrated Solutions Magazine
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Operationalizing Disclosure Intelligence For Go-To-Market Success
Regulatory intelligence goes beyond ensuring compliance. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start, and position themselves as industry leaders.
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A Bear-able E-Commerce Solution The Boyds Collection, Ltd. adopts a new Y2K-compliant e-commerce solution that provides its wholesalers with required bar code labels and advance ship notices. Chances are you’ve seen them, the porcelain and plush “Boyds” bears sold in department stores and on QVC, the cable home-shopping channel. The Boyds Collection, Ltd. (Gettysburg, PA)
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Hyland Software Customer Rochdale Metropolitan Borough Council Presents At Butler Group Enterprise Content Management Symposium In London Hyland Software, Inc., developer of the OnBase enterprise content management (ECM) software suite, announced that Hyland customer Rochdale Borough Metropolitan Council presented a case study regarding its installation of OnBase at the Butler Group Enterprise Content Management Symposium.
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Maximize Output From Full-Time Employees
Learn about project-based insourcing solutions designed to give clients laboratory services support with flexible timeframes, and eliminate worries about co-employment and other regulatory concerns.
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Physicians Medical Group Cuts Processing Time With Datacap Taskmaster Case Study: Physicians Medical Group
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Continuous Flow — An Emerging Alternative
Gain insights on transitioning from batch to continuous flow processes, the benefits of continuous flow chemistry, and ensuring regulatory compliance with Quality by Design (QbD) principles.
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Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration
A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.
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Electronic Informed Consent: Considerations For Implementation In Clinical Trials
In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.
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Malware Creativity Means VAR Opportunities To highlight the market opportunities for VARs, PC Tools released the findings from a worldwide survey of more than 25,000 respondents — of which 12,307 were from the United States. By Business Solutions magazine
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Become A High-Performing Clinical Site: Tools For Hospitals, Clinics, And Academic Centers
This paper will give you the keys to set up a new clinical site, find the right model, pass the sponsors’ feasibility processes, acquire the right technologies, familiarize yourself with rules and regulations, and successfully mitigate risks.
NEWS
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KETOS Launches In-House Environmental Lab Testing For Water Quality4/23/2025
KETOS, a leader in automated water testing solutions, today announced KETOS Environmental Lab Platform, its new in-house Environmental Lab Testing Services for residential and commercial clients.
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New Sustainable Production Facility For Coatings For Direct Food Contact Materials Is Established In Indonesia8/19/2025
DIC Corporation announced today that it has established a new production facility for coatings suitable for direct food contact materials on the site of a plant belonging to PT.
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u-blox Launches SIG 2.00 GNSS Firmware: 95%-Confidence Geolocation For Wi-Fi 6E/7/8 Access Points12/11/2025
u-blox, a global leader in positioning and short-range communication technologies for automotive, industrial and consumer markets, today announced the release of Standard Infrastructure GNSS (SIG) 2.00, a dedicated GNSS firmware solution for Wi-Fi 6E/7/8 access points operating in the 6 GHz band.
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Miros Sets A New Standard For Real-Time Collaboration With Launch Of Oil Spill Detection Monitoring Application4/2/2025
Designed to run on top of Miros’ trusted OSD system, this solution introduces a new level of real-time visibility, centralized collaboration, and full accountability for offshore operators, setting a new industry benchmark for proactive and transparent oil spill management.
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New Automated Cybersecurity Testing For Embedded Software Available In Compliance With RED II EN18031 Standard7/23/2025
Starting in August of this year, connected digital products will be required to comply with the EU Directive RED II (Radio Equipment Directive) EN 18031.