Sharepoint Solutions
PRODUCTS
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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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Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system, like MasterControl Manufacturing Excellence.
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Early Phase Experts
As a full-service contract research organization, Southern Star Research has the knowledge, industry relationships and technical expertise to get your early-phase clinical trial up and running safely and efficiently.
With a broad range of experience delivering Phase 1 Healthy Volunteer, First in Human, First in Patient and Phase 2 trials, we know just how important it is for your asset to succeed in the early development lifecycle. Our experienced team will help you obtain high-quality data that will appeal to future investors, meet the requirements of international regulatory bodies such as the FDA, EMA, PMDA, and Health Canada, and prepare your product for larger Phase 3 and 4 studies, partnerships, licensing, and sale.
Whatever your clinical trial needs, we can provide a flexible, bespoke solution that will not only meet your regulatory requirements but also position your product for commercial success.
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With 30+ years of experience in viral vector development and manufacturing, we bring unmatched expertise as your trusted CDMO for AAV. From plasmids to fill/finish and advanced analytics, we provide true end-to-end support, accelerating your path to the clinic and beyond.
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Track and manage defects and non-conformances – such as SOP deviations or missing data – from identification to resolution.
WHITE PAPERS AND CASE STUDIES
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GMP Calibration Management
Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.
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What Does The New FDA DHT Guidance Mean?
In December 2023, the FDA released the final version of its digital health technologies guidance, outlining the facilitated use of sensor-based DHTs and wearables in clinical investigations.
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NuGenesis 9.3 – What's New
Explore the latest features of a user-centric lab management system that comprises data, workflow, and sample management capabilities to support the entire product lifecycle.
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Antibody Coverage Analysis Of E. coli HCPs In The BL21(DE3) Strain
Review a study conducted to determine the suitability and similarity of Cygnus E. coli HCP ELISA Kits to quantify BL21(DE3) Host Cell Proteins (HCPs).
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Evansville Water & Sewer Utility: 4 Tactics For Managing & Organizing Vertical Assets
EWSU, serving 65,000 customers, revamped its vertical asset tracking with POWER Engineers to enhance maintenance workflows. Here's how they optimized their processes.
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Inspecting On The Edge — Understanding Punch Tip Wear
Why is a horizontal optical comparator highly recommended for tablet manufacturers as a measuring tool for punch tip inspection, and what strategies can be used to detect, reduce, and prevent tip wear?
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HVLD Technology Pre-Filled Syringe Inspection
Advanced HVLD technology delivers non-invasive, deterministic inspection for pre-filled syringes. Learn how this method improves reliability and patient safety compared to traditional approaches.
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Increasing Batch Size And Reducing Cycle Times For A Biologic
JHS partnered with a global pharma company to optimize biologic production, increasing output by 50% and reducing batch release times by up to 30%.
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OEE And Product Inspection
Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.
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Project Orbis Drug Registration 2025
Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.
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Development Of A Non-Standard Protein Therapeutic
Discover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.
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Patient-Defined Recruitment: The Movement Advanced By COVID-19
The pandemic forced the pharmaceutical industry to reimagine how we recruit patients to clinical trials – and it's delivering significant benefits to sponsors who embrace these changes.
NEWS
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PolyPeptide Strengthens Global Peptide Production With Modular Facility Design Approach9/24/2025
PolyPeptide Group AG (SIX: PPGN), a specialized, global CDMO for peptide-based active pharmaceutical ingredients, today announced the successful delivery and installation of pre-built modules at its Malmö, Sweden facility. This marks a key milestone in the company’s modular expansion project at the site, which aims to double its solid-phase peptide synthesis (SPPS) capacity.
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Using Cover Plants To Remove Pollutants From Arable Soil3/25/2025
Nitrate, pesticides, metals, plastic agricultural soils often contain pollutants. But are there sustainable and climate-friendly ways to restore and promote soil health in agricultural land? Yes, says a research team from the Helmholtz Centre for Environmental Research (UFZ).
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Cleanfarms And TNRD Launch Agricultural Plastics Recycling Pilot Program10/8/2025
Cleanfarms and the Thompson-Nicola Regional District (TNRD) are launching a new pilot program to recycle bale wrap and silage bags and covers.
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'A More Versatile And Powerful Foundation For Future Photonic Technologies'6/24/2025
The candidate pool for engineered materials that can help enable tomorrow’s cutting-edge optical technologies—such as lasers, detectors and imaging devices—is much deeper than previously believed.
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New Method To Pinpoint Soil Erosion Could Help Protect Waterways9/3/2025
Cranfield University experts have developed a new method to precisely identify soil erosion hotspots along waterways, allowing for pre-emptive mitigation measures to be put in place that protect land and water systems.