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Clinical operations
Biometrics
Clinical Operations
Clinical Trial Management
Mobius Medical offers comprehensive clinical trial management services in the United States, Australia, and New Zealand. If you’re seeking to conduct a clinical trial in any or all of these countries, you’ve come to the right place. We know that, paramount to any clinical trial’s success are:
- well forecasted timelines
- accurate creation and execution of document packages
- respectful and professional relationships with all key stakeholders
- powerful project management tools
- compliance monitoring
- robust medical /safety reporting processes
- quality oversight throughout the entire journey
United States:
The United States is a global leader in clinical research, with a robust regulatory framework overseen by the Food and Drug Administration (FDA).
With top class, highly experienced US staff managed by a seasoned Clinical Operations Leadership team, Mobius Medical is able to support and guide you in the preparation, management and complete oversight of your USA clinical trial.
Australia:
Australia has gained prominence in the global clinical trial landscape due to its R&D tax incentive programs, streamlined regulatory procedures and world-class research facilities.
Mobius Medical can help you navigate the TGA Clinical Trial Notification (CTN) scheme, act as your Local Australian Sponsor, and assist every step of the way in initiating and managing your Australian sites.
New Zealand:
New Zealand provides an ideal environment for conducting clinical trials with its efficient regulatory system and access to a diverse patient population.
With in-country expertise, Mobius Medical can accelerate your effort to conduct top quality research, with some of the most expeditious start-up timelines in the world, and data of the highest quality.
Site Support
Study Coordinator
Mobius Medical’s team includes registered nurses and research coordinators who can assist investigators with general clinical trial coordination duties such as:
Scheduling/conducting patient visits
Data entry, query management
Regulatory document upkeep
Investigational product accountability
Monitoring visit support
Clinical Case Support
Mobius Medical has a long and successful history managing a wide variety of medical deice trials. Many of these involve new or novel procedures requiring close support in the operating room or catheterisation lab. Mobius Clincial case support provides:
Hands-on assistance for investigator/team in OR/cath lab
Ensuring compliance to IFU/protocol
Assistance with technical issue/ troubleshooting
Supporting data collection per protocol
Extension of Sponsor experts unable to be present in person
Auditing
Mobius Medical has staff experienced in conducting site and study audits for both quality oversight and compliance. We can conduct specific gap analyses of standard operating procedures, processes and documentation, either as a pre-planned exercise or for-cause. In addition, Mobius Medical contracts a fully certified GCP auditor.
Decentralized Clinical Trials (DCTs)
Embracing innovation in healthcare, we’re revolutionizing the traditional clinical trial model. With a patient-centric approach, our decentralized trials empower participants by enabling remote engagement, reducing the need for frequent on-site visits. By leveraging digital tools and wearables, we enhance data collection accuracy and real-time monitoring, leading to more comprehensive insights. Experience a seamless, patient-friendly journey that accelerates research, fosters inclusivity and patient diversity, and paves the way for a healthier future.
Biometrics
EDC
Mobius utilizes the latest EDC software technologies to provide our clients with value for money, whilst ensuring compliance and quality of their trial data.
Custom built per protocol, in-house
Validated and assessed for 21 CFR Part 11 compliance
Several EDC platforms to select the system that is right for you
Electronic patient reported outcomes (ePRO), patient diaries and personalized data collection
Assistance in obtaining licensing and usage permissions
Data Management
Mobius has expert knowledge in all stages of the clinical trial data lifecycle that helps maintain the quality standards of Clinical Data Management (CDM) processes. We do this by:
Implementing the EDC in concert with a robust data management plan
Well-devised staff training strategy and roll-out
Aligning mutual interests to produce reliable data output
Robust policies and procedures to ensure compliance with international regulatory requirements
Biostatistics
We work with seasoned biostatisticians experienced in variety of therapeutic areas, phases and types of clinical trials. Our biostatistical services include: