Good Clinical Practice

Our highly experienced, trained and competent team of specialist GCP auditors has conducted thousands of audits in all therapeutic areas, according to international and national regulations, in over 85 countries. Continual positive client feedback is evidence of our professionalism and competency.


Thousands of GCP audits worldwide


GCP audits in all therapeutic areas


GCP audits in over 85 countries

Find out how ADAMAS Consulting can help with your next project

Recent examples of our work:

Management and conduct of mega-trial audit programme

Global 16 site for cause audit programme within short timelines

Global biennial vendor audit programmes


The conduct of GCP quality audits is becoming an increasingly challenging process, owing to the complexity of clinical trials and the location of investigator sites.  Although the majority of sponsor organisations reside in Europe, the USA and Japan, their clinical trial sites are often located in Asia, Africa, South America, the Middle East and Far East.  Not only are auditors challenged with physically reaching the investigator sites, but they also have to deal with the diverse cultures they encounter.  ADAMAS has a global reach with staff based across four continents. Not only does this help with language and cultural barriers, but also the travel time and cost for the conduct of these audits.

It’s surely been a pleasure meeting you. Thanks for conducting the audit with such a professional and competent attitude. Although demanding and to a certain extent even tough, once again my opinion on the audit concept can be nothing but positive and inevitably an educational opportunity.


Project Manager, Global Pharma Company

GCP Services

Investigator Site Audits

  • Routine Investigator Site Audits (Phase I to IV)
  • Targeted Investigator Site Audits (Phases I to IV)
  • For Cause Investigator Site Audits (Phases I to IV)

System Audits

  • System Audits of Sponsor/CRO/Phase I/BA/BE/ARO Operations

Mock Inspections

  • Inspection Preparation and Training (Investigator Site/Sponsor/CRO)
  • Mock Inspections
  • Inspection Facilitation

Data Management

  • Database Audits
  • Data Management System Audits

Trial Master File (TMF)

  • TMF Audits (paper and electronic)

Document Audits

  • Protocol Audits (all Phases)
  • Case Report Forms
  • Informed Consent Forms
  • Investigator Brochures
  • Clinical Study Reports
  • Development Safety Update Reports

Vendor Audits

  • Monitoring and Project Management
  • Data Management, Biostatistics and Medical Writing
  • Clinical Trial Supply
  • Interactive Response Technology
  • Translation Services
  • Archive Facility
  • Centralised ECG/Imaging Facilities

Consultancy Services

  • SOP Development
  • QMS Evaluation
  • Regulatory Intelligence

Contact Us

If you've got any questions or queries about our services, careers, or training, please get in touch.
We have 500+ years combined experience, working around the globe there isn’t anything we’ve not encountered in our sector. We're very approachable and happy to help.

The ADAMAS Corporate Brochure 2016


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

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’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.


How to be a Clinical Auditor

So you want to be a Clinical Auditor? An article written by CEO.Dr.

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.


Is your QMS compliant?

Identify whether your QMS is compliant to the upcoming ICH GCP Addendum

ICH (E6) R2 Addendum - Step 4


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How to be a Clinical Auditor

So you want to be a Clinical Auditor? An article written by CEO.Dr.