Our Services

We are your clinical trial research partner.

On this page:

Clinical operations

Clinical Trial Management
Site Support

Biometrics

EDC
Data Management
Biostatistics

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
USA

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:

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:

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

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

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

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

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

Electronic Data

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

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

Biostatistics

We work with seasoned biostatisticians experienced in variety of therapeutic areas, phases and types of clinical trials. Our biostatistical services include:

Expertise in design/protocol development

Sample size calculations

Modelling such as linear/non-linear regression modelling, mixed-effects, survival analysis, regularized regression

Statistical analysis plans (SAP)

Shells for tables, listings and figures (TLFs)

Interim and final analyses per protocol

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