Accelagen

Accelagen: your premier global contract research organization

At Accelagen, we are a leading global contract research organization (CRO) dedicated to co-creating meaningful outcomes that significantly impact the future of human health. Our mission is to provide pharmaceutical and biotech partners with an accelerated, globally recognized pathway to market success.

Accelerated pathways to market

We leverage our extensive knowledge of international markets to uncover the roadmap to success at every stage of the product lifecycle. Our expert teams in clinical development and regulatory affairs are backed by decades of experience, delivering high-quality data and proven results.

Unique reverse journey mapping approach

Accelagen employs a distinctive reverse journey mapping approach that builds a comprehensive picture of your end goals. We define your ambitions and key milestones, focusing on what your product will look like on the shelf. By working backwards, we map the steps necessary to achieve market approval, effectively eliminating re-submissions and delays.

Comprehensive clinical development services

As a globally adept CRO, Accelagen offers full study delivery across trial initiation, execution, and completion. Our decades of experience in drug and medical device development, combined with cutting-edge research technology, ensure the highest quality management of preclinical and Phase I-IV trials in accordance with international guidelines.

We customize our operations to deliver success across large multinational clinical trials and smaller single-site trials for specialized therapeutics. Our world-class in-house biometrics services support all clinical trial designs, including randomized controlled, parallel group, crossover, adaptive, retrospective, and prospective studies. Our innovative, user-friendly systems produce accurate, accessible, and reusable data.

Expert regulatory affairs services

With a proven track record of securing hundreds of approvals in Australia and internationally, Accelagen offers clear and accelerated regulatory strategies that maximize the likelihood of approval from the outset. Our experienced team tailors regulatory pathways to align with your strategic objectives, identifying key milestones and potential gaps in regulatory information.

We provide industry-leading guidance on strategic decisions throughout the product lifecycle, ensuring full benefit realization. Our expertise spans regulatory submissions across the globe, including Asia-Pacific, North America, and Europe.

Our regulatory affairs services encompass a comprehensive range of offerings, including the development of tailored regulatory strategies, dossier development and gap analysis, submission publishing and management, and marketing authorization. We also provide expert guidance on product lifecycle management and safety and pharmacovigilance, ensuring that every aspect of your regulatory journey is meticulously addressed to maximize the likelihood of approval and support your strategic objectives.

High-quality biostatistics and data management

Accelagen delivers top-tier Biostatistics and Data Management services that prioritize quality outcomes and regulatory compliance. Our in-house capabilities streamline the process of recording, analyzing, and reporting trial data comprehensively. We develop tailored data management solutions that align with the Clinical Data Interchange Standards Consortium (CDISC) best practices, ensuring data accessibility, interoperability, and reusability to meet ever-increasing regulatory standards.

Why choose Accelagen?

Our unique approach to collaboration and process allows us to work side by side with our partners to co-create meaningful outcomes that impact human health. We provide strategic direction and consultation from concept through commercialization, prioritizing an understanding of your journey and the broader context of your impact.

Our patient-centered, collaborative process draws upon extensive industry experience, enabling you to deliver a comprehensive and robust product to market faster. It’s this innovative approach that sets us apart and enhances the outcomes we generate for you.

Contact us today

Ready to accelerate your journey to market? Use the form above to send us your inquiry, and let’s work together to achieve meaningful outcomes in human health.