• Consulting

    The new realities in biopharma leave less margin for error. Success requires the right partner. With Axzons you can move forward with confidence.

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  • Axzons Markets

    Research & Development,Sales & Marketing,Public Health & Government,Payers & Providers,Medical Devices,Biosimilars.

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  • Services

    AXZONS offers a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to market faster. Our services span the entire lifecycle of product development and can be adapted to suit small local trials or large global programs.

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  • Clinical Trials

    Axzons is transforming clinical development by providing an integrated clinical solution with full-spectrum strategies and insights that have a proven impact on success.

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Achieve better outcomes with evidence and insight for better decisions.

Every stakeholder in the New Health needs more evidence to improve outcomes and reduce costs. Your partner for success is AZR...

Consulting Services

Clinical Trial Services

We Reduce Time to Market. AZR has reduced time to market through optimization of all aspects of the clinical trial process and functional areas. We reduce risk through milestone and performance-based agreements to move your product to the next stage towards approval within budget.

  • Ensure your trial gets off to the right start with the best possible operational strategy
  • Keep your trial on course with clinical trial management that delivers the efficiencies, rigor, and scale you need
  • Finish strong with a quality NDA submission built on smarter data collection, interpretation and reporting
  • Clinical Trial Planning & Design ­– we bring together a team of our specialists in trial delivery, drug development, therapeutic areas and commercialization. They analyze relevant market and historical data, our strategists create the optimal scenarios for your drug studies. We partner with you from clinical trial design through execution to enable smarter, faster decision-making.
  • Patient and Investigator Recruitment – To accelerate your patient recruitment, we build strong relationships with clinical investigators and sites, communicate directly with patients, and provide tools to identify and reach investigators and patients. It’s part of our Right Start process for optimizing trial start up.
  • Clinical Monitoring – We often supplement regular on-site visits with remote clinical monitoring and investigator support through centralized Project Management Centers. This combination helps manage site workflow, reduce investigator burden, improve data quality and accelerate database lock.
  • Clinical Trial Activation and Maintenance

    Drug development has never faced more challenges: Increasing costs, growing complexity, longer timelines. AZR helps you navigate every step using its systems, processes and expertise.

  • Preparation, submission and maintenance of INDs, CTAs, IMPDs and IBs (responsibility as surrogate for client or under Transfer of Obligation)
  • Liaison with regulatory agencies
  • Obtain import licenses/export permits
  • Clinical supplies label prep and/or review
  • Protocol and IB review
  • Facilitation of IRB/ethics committee submission and approval
  • Review labeling of clinical trial material
  • Investigational Drug Product release and shipment
  • Review protocol packages
  • Global Regulatory Consulting

    With offices across the globe, the regulatory affairs team at AZR is an experienced and effective liaison for the coordination and preparation of complex multi-national submissions with all major regulatory authorities.

    AZR provides regulatory consulting as a customized stand-alone service or through our full service clinical trials. Our regulatory professionals ensure client satisfaction through streamlined procedures that provide rapid turnaround of tasks, enabling faster start up and compliance with applicable guidelines.

    We can advise sponsors with strategic planning, development, evaluation, and preparation of regulatory submissions at all stages of development and post-marketing. We integrate regulatory and clinical development plans to our sponsor's pipeline strategies by performing regulatory, CMC, audits, and gap assessments to ensure submissions conform to the quality standards of regulatory authorities.

    Data Management Services

    The right EDC system for a study is determined by both project deliverables and budget.

    AZR's data management team has experience developing and deploying EDC study systems across several leading vendors including: Phase Forward, Medidata, Datatrials, DataTrak, and Oracle Clinical (paper).

  • eCRF design and Database deployment to 21 CFR Part 11 compliance
  • Database deployment to support Adaptive Design methods to make early decisions
  • Planning and implementation for submission-ready data strategies based on CDISC, SDTM and ADaM datasets
  • Data Programming including SAS software capabilities
  • Medical coding in MedDRA and WHO Drug
  • Integration of randomization into EDC systems, eliminating IVRS costs, with added benefit of full inventory control over supplies
  • Streamlining and reconcilling across SAE, CTMS, and study DB
  • Cross functional data review to identify and resolve issues
  • Functional outsourcing services for data management with capabilities in over 100 countries
  • Pharmacovigilance

    Our Pharmacovigilance experts specialize in managing clinical trial AEs and SAEs, including initial receipt, case processing and follow-up, medical review, and closure. Our services include:
    • AE case processing including SAE management and expedited reporting in the US, EU, and other countries
    • Responsible Person for EudraVigilance
    • Generation of MedWatch 3500A/CIOMS I forms
    • Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
    • Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction