Due Diligence

We help companies with a wide variety of due diligence challenges, using the depth of our in-house expertise. Projects range from assessing the quality of the clinical trials in an in-licensing deal to providing risk advice to companies providing clinical trial insurance.

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Independent assessment of data

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Advance notice of regulatory risks

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Insight of investment risk

Find out how ADAMAS Consulting can help with your next project

Recent examples of our work:

Due diligence on behalf of a client in the process of acquiring a leading CRO

Determining the status of compliance with GxP regulations, allowed a client to progress with an acquisition.

Assessed clinical trial data quality prior to in-licensing deal

One of the many strategic options that pharmaceutical companies are adopting is to fill their R&D pipeline with in-licensed compounds from other companies.

Part of the process of in-licensing compounds is to manage the inherent risk. Increasingly, companies that in-license compounds that are under clinical development want to manage the risk by understanding more fully the clinical programme. Are the current programmes robust? Will any of the programmes need to be repeated?

ADAMAS has the team, the experience, the skills and the competencies to conduct independent due diligence of a clinical development programme to help companies understand and manage the associated risk.

Thank you once again for your assistance and quick turn around on the report. The audit was quite thorough (as usual) and I know your findings opened some eyes here. I very much appreciate your professionalism and how you conduct the post audit TCs. Thanks again!

Global Clinical QA Director, Global Pharma Company

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.

Contact Adamas
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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