SERVICE & PRODUCTS
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![GettyImages-640168692-laboratory-equipment-tablet-quality]( "Navigate The Early Phases Of Product Development With Ease")
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.
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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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![GettyImages-1293772957-scientist-laboratory-computer-drug-development]( "Lead Optimization In Drug Discovery")
Altasciences specializes in lead optimization studies, helping you identify the most promising drug candidates through precise, data-driven preclinical screening. Our expert scientists tailor each study to your unique needs, utilizing efficient non-GLP screening protocols to accelerate decision-making. With streamlined study designs, clear data visualization, and rapid turnaround times, we provide actionable insights to advance your drug discovery pipeline.
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![GettyImages-1256953021_anatomy]( "Altasciences' CNS Center Of Excellence: Award-Winning Services")
Recognized globally as a CNS Center of Excellence, Altasciences has completed more than 200 preclinical and clinical neurological studies, in addition to providing formulation, manufacturing, and analytical testing services, as well as bioanalytical support. Speak with one of their experts!
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![GettyImages-1182436133 scientist, lab, research, oncology]( "Altasciences' Award-Winning Preclinical Research Services")
Industry leader in preclinical safety assessments across various therapeutic areas. 30+ years of experience in full range of in vivo non-GLP and GLP studies in both rodent and non-rodent species.
WHITE PAPERS & CASE STUDIES
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![GettyImages-1168921630 drug study]( "Streamlining Study Start-Up For Accelerated Drug Development")
Streamlining Study Start-Up For Accelerated Drug DevelopmentWhat is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.
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![Gene Therapy GettyImages-1164556175]( "FDA Recommendations For Gene Therapy For PMDs")
FDA Recommendations For Gene Therapy For PMDsExplore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).
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![GettyImages-1173740575 computer research data]( "Successful Special Procedure Study Conduct: Cerebrospinal Fluid (CSF) And Concurrent Muscle Biopsy")
Successful Special Procedure Study Conduct: Cerebrospinal Fluid (CSF) And Concurrent Muscle BiopsyWorldwide assisted a trial sponsor with a study exploring a novel therapeutic protein (TP) in 48 healthy volunteers.
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![Scientists In Lab GettyImages-1291031461]( "Nonrodent Models: Minipig Specialty Capabilities")
Nonrodent Models: Minipig Specialty CapabilitiesThe minipig's similarity to humans, availability, known disease status, and feasibility of genetic manipulation offer advantages over traditional species, impacting ethical considerations and cost of animals in biomedical research.
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![GettyImages-1207997703-dog-animal-vet-veterinarian]( "Development And Regulation Of Veterinary Monoclonals")
Development And Regulation Of Veterinary MonoclonalsAlthough veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
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![Antibodies And Proteins GettyImages-1364886992]( "Designing, Selecting, And Developing Bioconjugates For Clinical Success")
Designing, Selecting, And Developing Bioconjugates For Clinical SuccessAccelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.
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![GettyImages-924276310_pig]( "Characterization Of The Sinclair Nanopig™ For Biopharmaceuticals Safety Assessment")
Characterization Of The Sinclair Nanopig™ For Biopharmaceuticals Safety AssessmentDiscover groundbreaking data that supports the use of the Sinclair Nanopig™ to reduce reliance on traditional non-rodent species in drug development, validating its value in drug safety studies.
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![GettyImages-475447149-brain_neurology_glioblastoma]( "Partnering On An Innovative Hydrogel-Based Treatment For Glioblastoma")
Partnering On An Innovative Hydrogel-Based Treatment For GlioblastomaTreatments for glioblastoma multiforme (GBM) are in high demand. Learn more about the new possibilities for increased dosing and diffusion capabilities offered by nanoformed APIs.
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![GettyImages-1302380490-Vaccine Nasal Spray]( "Nasal Vaccine Development, Manufacturing, And Device Selection")
Nasal Vaccine Development, Manufacturing, And Device SelectionWhen developing a nasal delivery program, a partner with experience in development and manufacturing techniques who can see a program through small-scale clinical to commercial supply is crucial.
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![Diversity-GettyImages-1450298872]( "Patient Diversity: Identifying Challenges, Opportunities, And Best Practices")
Patient Diversity: Identifying Challenges, Opportunities, And Best PracticesBy listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.
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![GettyImages-1197955157-finances-money-financial-valuation]( "Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study")
Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 StudyExplore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO.
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![Vaccines and syringe in laboratory-GettyImages-1289691489]( "Preclinical Evaluation Of RSV Vaccines And Antivirals In BALB/c Mice")
Preclinical Evaluation Of RSV Vaccines And Antivirals In BALB/c MiceAccelerate your RSV therapeutic development with clinically relevant preclinical models and expert IND-enabling services that deliver the data needed to advance confidently toward clinical trials.
NEWS
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First Successful Clinical Trial Of VU319 Brings Alzheimer's Treatment One Step Closer12/19/2024
Researchers at the Warren Center for Neuroscience Drug Discovery, a clinical stage biotech within the Vanderbilt University School of Medicine Basic Sciences, have detailed the successful drug discovery of a Phase I Single Ascending Dose clinical trial of VU319, a drug for memory loss in people with Alzheimer’s disease and schizophrenia.
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Northway Biotech Enters Manufacturing Agreement With Kaida BioPharma For Lead Oncology Program KAD1015/21/2025
Northway Biotech, Inc. ("Northway Biotech"), an end-to-end biologics Contract Development and Manufacturing Organization (CDMO), and Kaida BioPharma ("Kaida" or the "Company"), an early-stage pharma company dedicated to advancing targeted anti-cancer therapies to address hormone-driven cancers affecting women, today announced they have entered into a manufacturing agreement for the production of Kaida's lead product candidate, KAD101.
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Bayer Submits New Drug Application To U.S. FDA For Elinzanetant For The Treatment Of Moderate To Severe Vasomotor Symptoms Associated With Menopause8/1/2024
Bayer today announced that a New Drug Application (NDA) for the investigational compound elinzanetant has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.
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Clinical And Translational Science Publishes Phase 1 Clinical Results Of Henlius' HLX142/18/2025
Recently, results from the phase 1 clinical study (NCT04534582) of Henlius’ denosumab biosimilar candidate HLX14 (a recombinant anti-RANKL human monoclonal antibody injection) was published in Clinical and Translational Science (IF 3.1).
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NeOnc Initiates Cohort 3 In Phase 1 Clinical Trial Of NEO212™, A Patented Novel Hybrid Drug Designed To Deliver 'Double Punch' Against Malignant Brain Tumors7/24/2024
NeOnc Technologies Holdings, Inc., a clinical-stage medical biotechnology company, has begun enrollment of patients for Cohort 3 out of 6 of the Phase 1 clinical trial of NEO212™, the company’s patented novel hybrid drug designed to deliver a ‘double punch’ against primary and secondary malignant brain tumors.
ABOUT
Clinical research
It is important that medication and equipment meant for human use is monitored for safety and effectiveness. This is the aim of clinical research. These medical researches monitor treatment regimens, diagnostic devices and medication to ascertain how safe and effective they are. The findings of these researches are useful in preventing, diagnosing and treating of diseases. The value of clinical research to modern medicine as it has helped unearth some crucial findings that have been instrumental in tackling some of the deadliest diseases. Clinical research has transformed modern medicine to its potent form that we all respect it for.
The effect clinical research has had on the medical landscape is yet to reach its peak. Molecular biology and genetics are some of the areas that still continue to deliver tremendous results. Due to clinical research once unimaginable heights in genomes have been achieved. These studies have also inched closer to finding permanent solution to cancers by establishing a link between cancerous growth and genetic changes. Conditions such as stroke, congestive heart failure (CHF) and rupture of atherosclerotic plaque have presented a medical puzzle as their symptoms and causes have never been clearly established. With the direction clinical research has taken, it will be possible to establish the causes of diseases that were once unknown.
The success in clinical research does not imply that they do not face fair amount of challenges. There is an increasing difficulty in recruitment and training of clinical investigators. This is usually down to the fact that many assume that clinical researcher are earning less than their colleagues in private practice. Managed care institutions also try to cut down on expenses by reducing the numbers and funding of those they refer to academic health centers. The funding of clinical research has not been sufficient for the clinical researchers to effectively carry on and achieve their targets.