Sharepoint Solutions
PRODUCTS
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![GettyImages-2032712502-scientists-tablet-training-labratory]( "Navigate The Early Phases Of Product Development With Ease")
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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![MRN watch and screen image]( "MRN Technologies")
Our research is powered by MRN owned, regulatory-approved and validated eClinical software systems. Our technology can be used at-site and at-home enabling fully integrated data through any clinical trial.
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![GettyImages-1295294256 doctor phone data]( "TrialKit eConsent")
Help your patients make informed decisions without burying them in paper
With electronic informed consent (eConsent) software, your patients can access consent forms using any device they choose. And because it’s part of TrialKit’s unified platform, both your patients and your study team get a seamless experience.
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![GettyImages-2024666721-meeting-table-office-business-man-doctors]( "Accelerate Path To Clinic With CMC Consultation Services")
In today’s competitive and capital-constrained cell and gene therapy environment, early decisions around Chemistry, Manufacturing, and Controls (CMC) can make or break a therapy's timeline, cost-efficiency, and eventual approval. Yet many emerging cell therapy companies struggle with CMC strategy until it becomes a bottleneck.
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![AAV Production]( "Power Your Gene Therapy Pipeline With A Proven AAV CDMO Partner")
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.
WHITE PAPERS AND CASE STUDIES
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![Antibodies GettyImages-512051390]( "Quantitation Of Monoclonal Antibodies In Serum")
Quantitation Of Monoclonal Antibodies In SerumMonoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
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![Pharma Manufacturing GettyImages-1135140594]( "Innovative ASD Technology Improves Abandoned Cancer Medication")
Innovative ASD Technology Improves Abandoned Cancer MedicationReview this case to learn how one solid dispersion technology lowered patients' pill burdens and demonstrated an improved therapeutic response for Galeterone.
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![Syringe-Staked-In-Needle-iStock-502347386 (002)]( "HVLD Technology Pre-Filled Syringe Inspection")
HVLD Technology Pre-Filled Syringe InspectionAdvanced 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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![Cytiva]( "Customer Story: Emergent BioSolutions Enhances Aseptic Filling Process")
Customer Story: Emergent BioSolutions Enhances Aseptic Filling ProcessUpgrading outdated filling systems is essential for meeting future production demands and regulatory standards. Learn how one manufacturer modernized its approach to ensure compliance and efficiency.
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![GettyImages-1139719728 FDA]( "What Does The New FDA DHT Guidance Mean?")
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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![GettyImages-623208264 lab, research, oncology]( "Streamlining Early-Phase Oncology Study Start-Up In Today's Clinical Environment")
Streamlining Early-Phase Oncology Study Start-Up In Today's Clinical EnvironmentExplore the significance of targeted therapies and adaptive trial designs that prioritize patient-specific characteristics.
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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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![Review, revise, repeat-GettyImages-2205869747]( "Forge Boosts Efficiency And Compliance During External Collaboration")
Forge Boosts Efficiency And Compliance During External CollaborationStreamlined collaboration and unified quality systems are helping CDMOs cut review times. Discover how connected workflows improve compliance and efficiency for faster delivery of life-changing treatments.
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![Solving The Silicone Challenge]( "Solving The Silicone Challenge In Pre-Fillable Syringes")
Solving The Silicone Challenge In Pre-Fillable SyringesDiscover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.
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![Flexan - manufacturing transfers]( "Manufacturing Transfers: Delivering 140+ Precision Medical Devices Without Missing A Deadline")
Manufacturing Transfers: Delivering 140+ Precision Medical Devices Without Missing A DeadlineGo inside a successful manufacturing transfer of over 140 Class-III silicone medical devices and on-time delivery for a top-30 OEM through expert project management and rigorous validation processes.
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![GettyImages-2223536069 protein]( "Development Of A Non-Standard Protein Therapeutic")
Development Of A Non-Standard Protein TherapeuticDiscover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.
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![GettyImages-1219894348-lab-cleanroom-PPE]( "The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics")
The Benefits Of End-To-End Formulation And Fill/Finish Of BiologicsProper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.
NEWS
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Axim Biotechnologies Files Pre-Submission With FDA For CLIA Waiver Pathway On Lactoferrin Point-Of-Care Diagnostic Test6/24/2025
Axim Biotechnologies, Inc. a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has filed a Pre-Submission (Pre-Sub Q) with the U.S. Food and Drug Administration (FDA) as the first formal step in seeking a Clinical Laboratory Improvement Amendments (CLIA) Waiver for its rapid, point-of-care Lactoferrin diagnostic test (TearScan Lf).
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CCC, Purifics Provide World's Most Advanced Oxidation Process To U.S. Navy10/20/2025
CCC is pleased to announce that it was awarded a contract by the United States Department of War (U.S. DoD) to provide the most advanced Photo-Cat Oxidation system available to the U.S. Navy.
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Interior Cuts Red Tape To Speed Water Infrastructure In The West11/25/2025
The Department of the Interior today announced Secretary's Order 3446, which streamlines federally funded construction projects at Bureau of Reclamation facilities across the 17 Western states.
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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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Comau Develops Innovative Industrial Collaborative Robotic Solutions As Part Of The CONVERGING Project11/26/2025
Comau is contributing to the European Union’s CONVERGING project, which aims to advance smart and reconfigurable production systems to meet the challenges of modern manufacturing.