Could a second, potentially more contagious wave, of COVID-19 bring further disruption to travel and clinical trial activities? Is it possible to meet the current oversight and compliance expectations of regulatory authorities?

We are all aware of the initial impact that COVID-19 has had on the healthcare sector and the increased risk it brought to clinical trial oversight and maintenance of data integrity. Many companies have embraced a ‘new normal’ in their approach to continue QA activities, by adopting a myriad of remote and risk based solutions, engaging risk mitigation strategies in alignment with the expectations of regulatory agencies across the globe.

At ADAMAS we believe that surveillance and preparedness are crucial. That is why we have developed services that can be flexible and meet a client’s individual challenges. We have successfully implemented a remote approach for all GxPs and we are confident that whatever challenges lie ahead we can ensure our clients remain compliant and help mitigate future risks.

Are you ready?

Please call us on +44 (0)1344 751 210 in Europe, +1-919-341-3361 in the US; or learn more about our remote services.

Ian Montague

Chief Executive Officer
ADAMAS Consulting
Ian.Montague@adamasconsulting.com

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.

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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?

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

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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.


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