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FEATURED ARTICLES

Healthy gut, food-GettyImages-1301830934 2 Challenges In Designing A Clinical Trial Exploring Personalized Elimination Diets

Vibrant Wellness clinical coordinator Suzanne Barker, MS, RDN, LDN, CGP, discusses how they faced and resolved two key issues when conducting a food sensitivity clinical trial.

WHITE PAPERS AND CASE STUDIES

SERVICES AND PRODUCTS

At Ideagen, we're committed to empowering seamless collaboration and enhancing your document review process. Through strategic alliances with leading technology providers across the life science industry, we offer integrations that amplify the efficiency and effectiveness of your workflows.

Accelerate Medical Writing Without Compromising Accuracy or Compliance

In the fast-paced world of clinical research, the ability to produce, review, and finalize high-quality documents—on time and with full regulatory compliance—is non-negotiable. Ideagen Document Review (formerly known as PleaseReview) is the trusted collaboration and co-authoring platform that enables clinical teams to streamline document reviews, reduce version chaos, and ensure traceable, auditable feedback across the board.

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.

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.

Streamline your Trial Master File (TMF) documentation and integrate with study sites to accelerate trial timelines.

Other eTMFs promise ease of use and seamless integration with the sites eISF, but they can’t deliver 100% adoption.

Effortlessly distribute, monitor, and exchange study documents with every site—wherever they work, whenever they need it.

Other tools promise site connections, but they can't deliver 100% coverage with a solution sites actually want.

Adoption

They claim sites use their tool…but you need sites to love it.

Tracking

They let you send documents…but you need to know the status of every document at every site.

Integration

They offer integration within their ecosystem…but you need compatibility with every site and sponsor software.

NEWS

  • Cutting-Edge Innovation Steals Spotlight On London Biotechnology Show 2025 Exhibition Floor

    The London Biotechnology Show 2025 exhibition floor was a vibrant epicentre of innovation, featuring nearly 100 exhibiting companies representing the entire biotechnology value chain—from laboratory equipment and health tech to compliance and logistics.

  • Nanoform Starts Pivotal Human Bioequivalence Studies Of Nanoenzalutamide

    Nanoform Finland Plc, the medicine performance-enhancing company, today announced that it had started pivotal relative bioequivalence studies of Nanoenzalutamide, the nanocrystalline-enabled enzalutamide tablet formulation, a potential alternative to the amorphous solid dispersion (ASD) used in XTANDI® (enzalutamide) [1], the number one prescribed androgen receptor inhibitor [2] approved to treat prostate cancer.

  • Australia Delivers Certainty For US Biotechs In 2025: Avance Clinical Offers Fast Start-Up, Regulatory Predictability, And R&D Rebates

    As regulatory uncertainty grows in the United States, US biotechs are increasingly looking to Australia as a stable and predictable launchpad for early-phase clinical trials. With its globally accepted regulatory framework, accelerated timelines, and 43.5% R&D rebate, Australia offers a compelling advantage — and Avance Clinical, Australia’s leading early-phase specialist CRO, is delivering the GlobalReady solution to help biotechs de-risk, conserve capital and accelerate their programs.

  • Reduce Complexity For Oncology Sites, Sponsors, Patients, And Caregivers

    Medable Inc. announced its next-generation digital oncology trial offering specifically designed to reduce operational complexity for sites and sponsors.

  • Meet With Avance Clinical At ASCO 2025 In Chicago

    Avance Clinical will attend and host a booth at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled from May 30 to June 3, 2025, at McCormick Place in Chicago, Illinois. This premier event brings together oncology professionals from around the world to connect, collaborate, and inspire advancements in cancer care.

  • Avance Clinical Honored With Frost & Sullivan's 2025 Global Customer Value Leadership Award

    Frost & Sullivan has named Avance Clinical the recipient of its 2025 Global Customer Value Leadership Award in the biotech contract research organization (CRO) sector, highlighting the company’s outstanding performance in delivering exceptional client value through innovation, service excellence, and technology-enabled trial optimization.

  • Novotech Welcomes New Investment From GIC, Temasek, And Existing Investor TPG To Accelerate Global Growth

    Novotech, a globally recognized full-service biotech specialist clinical research organization (CRO), announced today that affiliates of GIC and Temasek have signed binding agreements to acquire a significant stake in the company, with the additional capital earmarked to accelerate its global growth. Existing investor TPG will also reinvest through its TPG Asia fund.

  • Novotech Report Reveals Global Surge In Infectious Disease Trials As Industry Nears 2,000 Studies Since 2020

    Novotech a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development, has released a new report analyzing the evolving infectious disease clinical trial landscape. This report provides critical strategic insights for pharmaceutical and biotech companies navigating the complexities of global infectious disease research and development in 2025. 

  • Novotech Identifies Strategic Opportunities In Idiopathic Pulmonary Fibrosis Trials With Release Of Global Market Insights

    Sydney, April 2025 – Novotech, a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development, has released an in-depth report on the global clinical trial landscape for Idiopathic Pulmonary Fibrosis (IPF). The report offers strategic insights and comprehensive analysis critical for biotech and pharmaceutical companies navigating the complexities of IPF clinical research and drug development. 

  • Crucial Data Solutions Sets Another Industry Benchmark: TrialKit Now Available As A Native macOS App

    Crucial Data Solutions, Inc. (CDS), the pioneer behind the all-inclusive eClinical platform TrialKit, today announced the launch of TrialKit as a native macOS app—an industry-first for clinical trial software. This milestone makes TrialKit the only platform across all key interfaces: web, mobile (iOS and Android), and now Mac. With this latest expansion, CDS reinforces its leadership in modernizing clinical research technology and delivering unmatched flexibility for sponsors and CROs worldwide.

  • Avance Clinical To Showcase Asia-Pacific Clinical Trial Expertise At BIO Korea 2025

    Avance Clinical, a leading full-service global Contract Research Organization (CRO) specializing in high-quality, agile clinical biotech research services, will attend BIO Korea 2025 to meet with biotechs and share clinical trial capabilities across the region including Australia, New Zealand, South Korea, Taiwan, North America and beyond.

  • Novotech Expands South Korean Presence With New Hospital Trial Site Deal

    Australian CRO Novotech has signed a memorandum of understanding with the Kyungpook National University Hospital (KNUH), furthering its partnership strategy in South Korea.

  • Novotech Named Best Contract Research Organization In Australia At Asia-Pacific Biopharma Excellence Awards 2025

    Novotech, a globally recognized full-service clinical research organization (CRO) and scientific advisory company that provides biotech and small- to mid-sized pharma companies an accelerated path to market has been recognized as the Best Contract Research Organization in Australia at the Asia-Pacific Biopharma Excellence Awards (ABEA) 2025. 

  • Novotech Report Reveals Growth In siRNA Research

    Sydney, March 2025 – Novotech, a globally recognized full-service clinical research organization (CRO) and scientific advisory company, has released its newest preclinical report exploring the evolving landscape of small interfering RNA (siRNA) therapeutics. This report provides insights for biotech and pharmaceutical companies leveraging RNA-based precision medicine to develop next-generation treatments for oncology, metabolic disorders, and rare genetic diseases.