Transactional Content Management
PRODUCTS
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![Europe iStock-490822468]( "European Regulatory Development")
Scientific knowledge to strategize viable and efficient drug and device development pathways to achieve successful outcomes.
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![GettyImages-1189302612 doctor]( "Regulatory Sciences")
We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.
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![SoftmaxProGxp]( "Meet Regulatory Guidelines In GMP/GLP Labs With SoftMax Pro GxP Software")
Become compliant with FDA 21 CFR Part 11 and EudraLex Annex 11 software validation
SoftMax® Pro 7.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 and EudraLex Annex 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support our microplate readers.
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![GettyImages-1719538555 in home nurse visit patient]( "Clinical Research Solutions")
A global team of trusted experts for multi-phase clinical development.
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![Pharmaqualitymanagement]( "Pharmaceutical Quality Management System (QMS) Software")
Managing documents, training, and business processes are nightmares shared by all pharmaceutical and biotech companies and MasterControl provides pharmaceutical quality management software systems to take them out from that nightmare. MasterControl's QMS software exchanges the nightmares for a dream of a solution that enables pharma companies get their products to market faster and improve compliance at the same time. MasterControl pharma QMS software has been specifically designed to help manage all documents and automate regulatory-related processes and training in a single platform.
WHITE PAPERS AND CASE STUDIES
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![GettyImages-1463515619 home visit nurse]( "The True ROI Of Decentralized Clinical Trials")
The True ROI Of Decentralized Clinical TrialsGain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.
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![Planning GettyImages-1349390515]( "Removing Chaos In 3 Steps: A Guide To Planning TMF Migrations")
Removing Chaos In 3 Steps: A Guide To Planning TMF MigrationsKnowledge and planning are the keys to successful trial master file migrations. Utilize this guide when navigating the most important part of any TMF migration: project scoping and planning.
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![GettyImages-136640925-vial-vaccine]( "Leveraging The Bolar Exemption To Accelerate Market Access")
Leveraging The Bolar Exemption To Accelerate Market AccessGain insight into the changing comparator sourcing landscape, focusing specifically on the instrumental role the Bolar exemption plays in the shift away from dependence on innovators for clinical supplies.
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![GettyImages-1704680401-Clipboard]( "Re-Engineering A Complex Process For FDA Compliance")
Re-Engineering A Complex Process For FDA ComplianceDiscover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.
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![Eye Care Delivered]( "Overcoming Unexpected Obstacles In A Phase 1 Study")
Overcoming Unexpected Obstacles In A Phase 1 StudyDiscover how the implementation of mobile vision clinics (MVCs) was used to enhance efficiency in a Phase 1 clinical trial.
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![Doctor Using Digital Tablet GettyImages-1530254515]( "How Vanguard Clinical Harnesses CDMS/EDC For Faster Results")
How Vanguard Clinical Harnesses CDMS/EDC For Faster ResultsUncover how this CRO was able to stay agile by choosing a CDMS/EDC partner that prioritized sponsor needs and streamlined operations to achieve top-tier results swiftly.
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![Human DNA 876819212]( "How Can The Industry Drive Down The Cost Of Viral Gene Therapies?")
How Can The Industry Drive Down The Cost Of Viral Gene Therapies?This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.
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![GettyImages-1292777576 doctor computer]( "The Business Case For EHR eSource In Clinical Trials")
The Business Case For EHR eSource In Clinical TrialsExamine how manual data collection challenges prompted the adoption of an eSource solution that streamlined data entry, saving time and costs, reducing errors, and accelerating a multicenter phase 2 trial.
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![GettyImages-1368058797-vial-medicine]( "Full Scale Operations For Parenteral Pharmaceuticals")
Full Scale Operations For Parenteral PharmaceuticalsExplore how a project team accelerated through milestones in development, approval and execution of Equipment Evaluations, Equipment Specification Documents, Installation Qualification, and Operational Qualifications.
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![iStock-1194918059-continuous-improvement]( "PlantPAx Distributed Control System Reduces Downtime For Mallinckrodt")
PlantPAx Distributed Control System Reduces Downtime For MallinckrodtLearn how the nation's leading supplier in prescription pain medication completely upgraded their control system, resulting in greater diagnostic/troubleshooting information and reducing downtime.
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![Mueller Meter in pit]( "Newport News, VA Deploys 130,000 Mueller AMI Meters")
Newport News, VA Deploys 130,000 Mueller AMI MetersEight years ago, Newport News started having discussions about moving away from reading their mechanical, manually read meters every other month to go to monthly billing. Knowing they did not have adequate staffing to handle that task, the department decided to outsource its meter reading responsibilities to a third party.
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![RAH-SpeedyLight]( "R.A.H Solutions Finds Its Niche With SpeedyLight+")
R.A.H Solutions Finds Its Niche With SpeedyLight+Discover how a contractor found its niche in trenchless pipe repair by using the Speedylight system, which is a minimally invasive way to repair pipes.
NEWS
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More Colours For A High-Performance Quantum Internet2/10/2025
Data security on the internet is under threat: in the future, quantum computers could decode even encrypted files sent over the internet in no time.
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Pioneering 'Hybrid Chips' To Make The Most Advanced Square Centimeter Even More Efficient5/27/2024
TU/e is the ideal place to bring electronics and photonics together and accelerate the digitization of our modern lives.
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Sites Contaminated By Toxic 'Forever Chemicals' Are Much More Widespread Than Previously Thought, Researchers Find9/9/2025
Toxic per- and polyfluoroalkyl substances, also known as PFAS or “forever chemicals,” are in everything from Band-Aids and clothing to water and floss.
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Imperial And BASF Spinout SOLVE To Digitally Transform Chemical Manufacturing7/12/2024
A new spinout will use AI and innovative experimental methods to improve the manufacturing of products such as drugs and fertilisers.
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Low-Noise Transducers To Bridge The Gap Between Microwave And Optical Qubits3/19/2025
In the effort to build superconducting quantum computers, researchers around the world are working to develop electrical circuits that operate in the microwave domain using individual particles of microwave radiation, or microwave photons, as qubits—the basic building blocks of quantum computing.