If you are developing a system for use in clinical research, pharmacovigilance, or more generally in the pharmaceutical industry, ARONE can help you with this task and with implementation.
ARONE has been working hand in hand with the pharmaceutical industry since 1998
The pharmaceutical sector is highly specific and is subject to a host of strict regulations. Since its very beginnings in 1998, ARONE has been working for and with the pharmaceutical industry. Its founders and staff are all drawn from the industry. They are therefore acutely aware of its needs and have further refined their expertise over time.
We can help you ...
We can help you design, analyze and validate IT systems by:
- Interviewing target users and operators,
- Writing User Requirement Specifications,
- Identifying regulatory risks,
- Writing operational and technical specifications,
- Preparing test protocols,
- Running tests,
- Writing validation reports (see GAMP5, traceability matrix, risk analysis, etc.)
- Auditing IT service providers (software publishers, IT development company, hosting company, etc.)
- Reviewing code,