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Clinical TRIAL EXECUTION

Expertly managed trials

Whether you’re running an early feasibility or pivotal study, we execute with the highest standards of quality and compliance. Our team manages every moving part—from site selection to data integrity—so you can stay focused on innovation.

Clinical Trial Execution

Whether it’s first-in-human or a pivotal trial, we help you execute with precision while adhering to the highest level of quality standards. We keep your trial on track, handle training, submissions, and everything in between.

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What we can help with

  • Plans and document package creation
  • Site selection, qualification, and approvals
  • IP handling, activation, and enrolment
  • End-to-end clinical trial management including site management and monitoring to close-out
  • Robust clinical trial management system and integrated, compliant eTMF
  • Safety monitoring and reporting to required regulations
  • Compliant EDC and ePro tools
  • Biostatistics and analysis
  • Clinical investigation reports
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What global teams say about us

Our reputation is built on responsiveness, reliability and compliance

CASE STUDY

Revolutionising sperm selection with safer, stress-free technology

A new electrophoretic system offered a faster, safer alternative to conventional sperm selection. In a multicentre pivotal trial, it outperformed Density Gradient Centrifugation, matched Swim-Up, and showed no adverse events—supporting CE Mark submission.

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CASE STUDY

Early feasibility to global pivotal trial for mitral valve innovation

An innovative repositionable mitral valve system underwent early feasibility trials in Australia before scaling to a global pivotal study. Results showed durable valve function, improved survival, and quality of life—culminating in CE Mark (2020) and FDA approval (2025).

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CASE STUDY

Validating a non-invasive pain relief device for pregnancy

Pregnant women in their third trimester experienced better sleep and less pain using a specialised maternity airbed tested in a Mobius-run pilot trial. The study validated safety, comfort, and efficacy—proving a non-invasive way to ease late-pregnancy discomfort.

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Guiding you through what you don’t know yet

We answer the questions you may not even know to ask, from readiness to cost, timelines to regulatory differences, so you can move forward with clarity.

What is included in clinical trial execution?

End-to-end management: site selection, contracting, monitoring, data management, and reporting. We coordinate every operational detail to ensure smooth delivery.

How do you select and manage clinical sites?

We leverage long-standing investigator relationships across ANZ and the US. Sites are chosen for relevant experience, patient access, and reliability—and we stay closely involved throughout.

How do you ensure data quality and compliance?

All studies follow ISO 14155 and ICH GCP. Continuous monitoring, database checks, and real-time query resolution ensure complete, reliable datasets.

What’s your approach to communication with sponsors?

You’ll have a single project manager as your point of contact, backed by our Senior Management and specialist consultants as needed. We maintain transparent reporting and regular cadence calls for full oversight.

Can Mobius support hybrid or decentralised trials?

Yes. We’ve delivered decentralised and hybrid studies using digital recruitment, telehealth follow-ups, and remote monitoring—all within regulatory frameworks.

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Trust Mobius to move 
your clinical trial forward

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