Records Management
PRODUCTS
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![GettyImages-139602926 labeling, packaging, pharma]( "Packaging Software: OEE, EBR, Track And Trace")
Werum PAS-X Packaging optimizes efficiency, compliance, and transparency in your packaging line, combining OEE monitoring, electronic batch recording, and track & trace in a single scalable system.
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![GettyImages-849207658 Drug toxicity concept]( "NDA Submissions 505(b)(1) Or 505(b)(2)")
There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.
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![GettyImages-2024513353 drug manufacturing]( "Clinical Operations: From Study Feasibility And Recruitment To Trial Monitoring And Quality Assurance")
Our Approach
At Southern Star Research, we have extensive experience across all aspects of clinical operations and a wide range of therapeutic areas. We specialize in providing flexible, high-quality, and custom solutions that help you deliver regulator-ready data on time and at a predictable price.
As a large proportion of our clients are geographically dispersed, we understand how important it is to be able to trust that your CRO is working in your best interests. That’s why we pride ourselves on building strong, transparent, and close relationships with our clients.
Our team of experts will guide you through the clinical trial process using a proactive and collaborative approach, ensuring that your stakeholders are always informed, in control, and confident throughout the journey.
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![castor epro thumb]( "Electronic Patient Reported Outcomes (ePRO)")
Capture data at the true source: the patient. Improve the patient experience with secure, accessible questionnaires both via email and through the Castor Connect mobile application.
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![GettyImages-539843648 regulations doctor]( "Manufacturing And Import License (MIA) And Batch Certification")
Navigating both the specific country and general European regulations and requirements to supply medicinal products to the European markets can be a complex challenge. This applies both to Marketing Authorisation Holders (MAH) of approved commercial medicinal products and Sponsors of clinical trials.
WHITE PAPERS AND CASE STUDIES
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![DouglasPharma-CISO Feature]( "Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA Submission")
Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA SubmissionThe dynamic pharmaceutical landscape demands agility and strategic foresight. Explore how leveraging a key partnership helped to overcome a looming patent expiry for a second-generation acne medication.
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![HOD UV positioned at the outlet of the PW tank]( "Disinfection For Purified Water Loop For Kamada Pharmaceuticals, Israel")
Disinfection For Purified Water Loop For Kamada Pharmaceuticals, IsraelAn Atlantium HOD™ (Hydro-Optic Disinfection) UV system was installed at the outlet of a PW tank to serve as the primary disinfection barrier, with water circulating through the system at 6m³/hr before reaching the points of use.
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![GettyImages-1131583289-scientists-laboratory-monitor-screen-computer]( "Building A Scalable Digital Foundation To Support CGT Manufacturing")
Building A Scalable Digital Foundation To Support CGT ManufacturingExplore how digital systems strengthen CGT manufacturing by improving traceability and managing batch‑of‑one, as well as essential steps toward scalable, integrated operations.
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![Germfree - interior-cell-therapy-modular-facility]( "Inside A Collaboration To Design Cutting Edge Modular Cleanrooms")
Inside A Collaboration To Design Cutting Edge Modular CleanroomsLearn about a collaboration that has yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.
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![Attaching acoustic node for permanent leak monitoring (002)]( "How Omaha Reduced Water Loss And Costs With Smart Hydrant Monitoring")
How Omaha Reduced Water Loss And Costs With Smart Hydrant MonitoringPermanent acoustic sensors turn fire hydrants into a high-tech defense against water loss. By monitoring pipe sounds 24/7, utilities can identify and fix hidden leaks before they cause expensive, unplanned service disruptions or emergency flooding.
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![Artificial Intelligence IDEA, AI light Bulb Idea-GettyImages-2164746643]( "The Impact Of Artificial Intelligence On CQV")
The Impact Of Artificial Intelligence On CQVAI is revolutionizing CQV in life sciences by automating documentation, enabling real-time monitoring, and driving predictive quality to boost efficiency and compliance across validation processes.
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![GettyImages-614956020 textile factory]( "Color Consistency In UHMWPE Medical Textiles")
Color Consistency In UHMWPE Medical TextilesColor consistency improves surgical visibility, differentiation, and workflow efficiency, requiring medical textiles that deliver strength, compliance, and reliable quality in every color.
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![GettyImages-1074493878 (1) burst pipe]( "Hot Springs Combats Aging Infrastructure Challenges With Xylem Digital Solutions")
Hot Springs Combats Aging Infrastructure Challenges With Xylem Digital SolutionsThe City of Hot Springs, Arkansas knows the challenges of dealing with aging infrastructure well. The city’s 143-year-old system covers 923 miles of water mains in rocky terrain, making it difficult to detect leaks. That is why the utility’s water department decided to act.
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![Isolated Antibody Drug Conjugates ADCs GettyImages-1438509824]( "Reducing ADC Timelines With Integrated Development And Manufacturing")
Reducing ADC Timelines With Integrated Development And ManufacturingADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.
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![GettyImages-1452403953-patient-recruitment-selection]( "Streamline Recruitment With Confidence")
Streamline Recruitment With ConfidenceTransform your clinical trial recruitment with a service that delivers faster, more cost-effective enrollment, particularly for hard-to-reach populations.
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![GettyImages-2207572929-tablet-data-model-pen-hand]( "How A Complex Personalized Medicine Trial Migrated RTSM Software Without Disruption")
How A Complex Personalized Medicine Trial Migrated RTSM Software Without DisruptionDiscover how a clinical-stage biotech automated its supply chain to protect patient enrollment and eliminate manual errors in a complex, multi-national genetic medicine trial.
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![custom-objective-close-up]( "Custom Microscope Objective Case Study")
Custom Microscope Objective Case StudyMelles Griot custom objectives deliver superior imaging, color correction, and system repeatability—tailored for demanding applications where standard microscope optics fall short.
NEWS
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Controlling Quantum Motion And Hyper-Entanglement5/22/2025
Manuel Endres, professor of physics at Caltech, specializes in finely controlling single atoms using devices known as optical tweezers.
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Diversified Energy Expanding Leadership Position In Oklahoma With Accretive Acquisition Of Canvas Energy9/9/2025
Diversified Energy Company PLC (LSE:DEC; NYSE:DEC) (“Diversified” or the “Company”) is pleased to announce that it has entered into an agreement to acquire Canvas Energy (the “Seller”) (together with the assets, the “Acquisition”) for total consideration of approximately $550 million.
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Ancient Grain Has Huge Climate Potential And Could Play A Key Role In Europe's Future4/9/2025
Sorghum is one of the world’s oldest grains and possesses many traits that can benefit food security, climate resilience, and biodiversity.
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Foreign National Indicted And Extradited To The United States For Role In Two Russia-Linked Cyber Hacking Groups12/9/2025
On December 9, 2025, U.S. EPA and U.S. Attorney’s Office for the Central District of California and the Federal Bureau of Investigations (FBI) announced that a Ukrainian national has been charged with participating in conjunction with two Russia-linked criminal groups that conducted dozens of cyberattacks internationally, including against the United States.
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The Aussie Way Into Robotic Milking3/17/2026
Recently, we had the pleasure of visiting two progressive dairy businesses in Northern Victoria that perfectly demonstrate how Lely Automatic Milking Systems (AMS) are being adapted and implemented the Australian way.