Blog Of The Day

The case of an experienced contract monitor removing themselves from a study, not returning original documents and not completing any of the monitoring activities (such as monitoring reports). In this particular case, the monitor did not invoice for the work and...

ADAMAS recently held an internal training session for all their consultants on the topic of Investigational Medical Devices (IMDs).  This was run Dr Joerg Holzinger, ADAMAS’ ‘subject matter expert’ in response to an increasing number of enquiries for assistance in...

The Trial Master File (TMF) comprises all those essential documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.  These documents serve to demonstrate the compliance of the investigator, sponsor...

Over the years ADAMAS had assisted clients in a number of paediatric projects covering various therapeutic areas.  These have included studies related to treatment of infections in neonates, prevention of bleeding during surgery, treatment of ADHD and a vaccine study,...

The audit report is the final deliverable, following an audit, and must therefore, be able to communicate, effectively, what was done and what was found, to the people commissioning the audit, as well as the auditees.  This is not an easy task, and many auditing...

After 20 years in Clinical Quality Assurance I was actually starting to doubt myself.  A few days ago I was requested to provide a proposal for a systems audit of a service provider, but we only had one day in which to do the audit!  I explained to the potential...

As contract auditors, the one area that we are frequently asked to reduce time for in proposals is preparation. I often wonder whether the client company realises what a false economy this actually is. Unfortunately, this is usually a decision made by the finance or...

Part 2 When the inspection is in progress, keep the inspection team addressed of any issues or problems as they arise.  If there are known issues with trials, explain the issue and the resolution taken to address that issue.  Explain and express the reasons for any...

Part 1 Firstly, it is important to understand that inspections should not be considered as either “successful” or “unsuccessful”. They take place based on the relevant legislative requirements, and findings that arise are a result of inadequacies in the quality...

Welcome to the brand new Adamas Consulting CQA blog on the brand new website. With the launch of the new site, we'll be launching few new features; a blog where we'll be talking about the latest news and events from Pharmaceutical & Biotech industry; Linked in and...