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 the quality of the data produced.  These documents serve to demonstrate the compliance of the investigator, sponsor...

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 treatment of infections in neonates, prevention of bleeding during surgery, treatment of ADHD and a vaccine study,...

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 was found, to the people commissioning the audit, as well as the auditees.  This is not an easy task, and many auditing...

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 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...

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 the client company realises what a false economy this actually is. Unfortunately, this is usually a decision made by the finance or...
The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

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Regulatory Environment

 

The development of medicines is the most regulated industry in the world, and compliance at each stage of the research and development process, as well as after licensing, is critical to ensuring high quality and safe medicines reach patients in a timely manner.

adamas-quality-assurance-services

 

ADAMAS’s consultants have expertise across the G’X’Ps in pre-clinical, clinical and post-licensing areas. They have worked across many different therapeutic areas and product types including oncology, vaccines, biologics, medical devices and gene therapy. As a company we have developed close partnerships with our clients to support them in their development programmes and post-licensing activities, and to guide them successfully through their worldwide regulatory inspections.

 

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How to be a Clinical Auditor

 

‘So you want to be a Clinical Auditor?’, an article written by CEO Dr. Patricia Fitzgerald.

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Benchmarking Data

 

Please download our benchmarking data sheet, to see how these data compare with your own performance. To discuss a more detailed report, or analysis of a data subset, please get in touch.

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Is your QMS compliant?

 

Is your QMS compliant to the upcoming ICH E6 Addendum? Download our 5-point checklist

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ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

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