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Medical Devices

ADAMAS recently held an internal training session for all their consultants on the topic of Investigational Medical Devices (IMDs).  This was run Dr...

Trial Master File Reference Model

The Trial Master File (TMF) comprises all those essential documents which individually and collectively permit evaluation of the conduct of a trial and...

Paediatric Studies

Over the years ADAMAS had assisted clients in a number of paediatric projects covering various therapeutic areas.  These have included studies related to...

Realistic Audits – Reporting

The audit report is the final deliverable, following an audit, and must therefore, be able to communicate, effectively, what was done and what...

Realistic Audits – Conduct

After 20 years in Clinical Quality Assurance I was actually starting to doubt myself.  A few days ago I was requested to provide...

Realistic Audits – Preparation

As contract auditors, the one area that we are frequently asked to reduce time for in proposals is preparation. I often wonder whether...