Biostatistics & Data Management

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Biostatistics & Data Management

We appreciate data is our common currency for a range of eventualities:

1. Go/No Go decisions for subsequent development phase

2. Regulatory market authorisation

3. Market access and health technology assessment

At Axcellant our Biostatistics and Data Management team are most proficient in statistical modelling, programming and data collection methodology.

We have a 21 CFR Part 11 compliant in-house developed readily interfaceable eCRF system that has been used by many of our customers.

Our programmers are also well acquainted in developing eCRFs using the commercially available platforms.

In our pursuit to ensure competency remains ahead of opportunity.

The Biostatistics and Data Management team are leading the effort on the leveraging of ‘Big Data’, Block Chain and the role of artificial intelligence.

Services

Medical Devices

Our skilled team of professionals brings together a wealth of experience garnered over numerous successful projects

Clinical Development

We provide clarity where there is ambiguity and find opportunities when there is uncertainty.

Clinical Operations

Our operations team have broad and deep insights in the local ethics and regulatory framework.