It’s a tough choice – new drugs for patients or the health and safety of your valued staff?

With ADAMAS Consulting, you do not have to choose.

As we keep hearing these are unprecedented times, and just recently there have been concerning articles in the scientific press suggesting that recent outbreaks of SARS-CoV2 (different strains) are more infectious. One way or another COVID-19 continues to affect our decision making and looks like it will continue to do so for the foreseeable future.

As if there were not enough challenges when trying to plan Quality Assurance activities in both the near and long term, there are now a raft of new questions to address:

“When can I resume our on-site audit program?”

“What if the MHRA, FDA or EMA drop in for an audit?”

“How can we protect data integrity and ensure our Clinical Trials remain compliant?

“Do I have enough measures in place to keep our employees safe?”

As CEO of a professional services company, these are questions I have also faced. Decisions almost hourly about when or even if staff travel is safe, responsible and even practical, whilst endeavouring to ensure our clients receive the QA support that is warranted by the same regulatory bodies I have already mentioned.

In this volatile and uncertain environment, new dilemmas present themselves daily. These challenges need new solutions.

At ADAMAS we already have several solutions available and a portfolio of bespoke remote services to address these compliance challenges.

We will be leveraging software-based detection algorithms to support data driven decisions, and creative remote and risk-based solutions that ensure previously exclusively on-site audits can now be handled remotely.

Our most experienced auditor recently commented that remote auditing offers a concentrated and potentially superior product compared with some on-site solutions due to the lack of distractions the auditors encounter.

It is not just an option anymore; it appears to be the option.

ADAMAS has been perfecting innovative and dynamic solutions to meet our clients pressing challenges for nearly 25 years. We continue to do so. We have a demonstrable history of thought leadership and execution. As ever, we are now the first to develop and deploy best in class solutions to help face the difficulties encountered by our clients as these unprecedented times seem to linger.

I can say with pride and confidence our team can help you to answer the questions and challenges we are all facing together.

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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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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