COVID-19 SERIES

INTRODUCING ADAMAS REMOTE SERVICE OFFERINGS

Is it possible to monitor compliance, maintain oversight and manage risk during the COVID-19 pandemic? At ADAMAS we have the right answers to these questions. During these uncertain times we can offer a measure of reassurance.

DISCOVER REMOTE SERVICE OFFERINGS WITH ADAMAS

ADAMAS remote service offerings can help you:

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Monitor Compliance
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Maintain Oversight
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Manage Risk
ADAMAS have the experience, know-how and tools to provide remote service solutions to meet these challenges.

Mitigation and Management

Regulators have set a clear expectation that compliance and Sponsor oversight are maintained at all times, even if it is not possible to conduct compliance activities on site as would be normal practice.

ADAMAS remote service offerings provide solutions and assurance with credible alternatives.

Remote Auditing – The ADAMAS Approach

At ADAMAS we are committed to supporting our clients and providing the best possible solutions which can be individually tailored. Remote auditing offers a viable alternative for maintaining compliance oversight where security, travel or other factors may impose restrictions.

Remote Auditing – The ADAMAS Approach

At ADAMAS we are committed to supporting our clients and providing the best possible solutions which can be individually tailored. Remote auditing offers a viable alternative for maintaining compliance oversight where security, travel or other factors may impose restrictions. For a remote audit to be successful, planning is key. Here at ADAMAS, we implement the right methodology to mitigate any potential challenges and ensure the audit is successful. ADAMAS understand that while we are familiar and experienced in this offering, remote audits may be unfamiliar to some. We are adaptable and flexible, drawing on our extensive experience and knowledge to support you.

SERVICE OFFERINGS

Discover how ADAMAS can provide you with tailored compliance solutions

Quality Investigator Site Assessment

QISAs allow the evaluation of key aspects covered during an ISA

Vendor Assessments

Due diligence on behalf of a client in the process of acquiring a new vendor

Mock Inspections

Mock GCP and Pharmacovigilance Inspections conducted remotely to specification

SOP Development

GxP SOP Gap Analysis.
New and revised SOP creation and review

QMS Consultancy

Assess the effectiveness of your
quality management system
Register your interest today and see how ADAMAS can help you remain compliant

ADAMAS COVID-19 SERIES

COVID-19 | Mitigation & Management

As COVID-19 Brings Global Uncertainty, Can We Maintain Certainty Regarding Our Regulatory Obligations? ADAMAS has brought together a range of specific remote service offerings which will not only ensure you can maintain compliance, but also have peace of mind that while we navigate these current challenging times together your compliance...
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COVID-19 | Conducting Remote Audits

Following the recent confirmation from Regulatory Authorities that GxP compliance should be maintained during the coronavirus outbreak, encouraging alternative approaches for routine regulatory oversight, remote auditing represents the viable alternative during these unprecedented times. If you would like to learn how ADAMAS utilise our extensive experience in this area to...
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COVID-19 | A Novel Virus Needs a Novel Approach

The ICH guideline for Good Clinical Practice states that sponsors should evaluate identified risks against existing risk controls by considering “the likelihood of errors occurring, the extent to which such errors would be detectable, and the impact of such errors on human subject protection and reliability of trial results” (ICH...
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COVID-19 | Guidance on the Management of Clinical Trials

Introduction The COVID-19 pandemic has imposed unprecedented challenges on Sponsors, Investigator Sites and Clinical Trial participants. The potential risks of this global COVID-19 outbreak include: Rise in Good Clinical Practice (GCP) non-compliance Increase in the number of protocol deviations Insufficient evidence of Sponsor and Investigator oversight Interruptions to the investigational...
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COVID-19 | Maintaining Inspection Readiness

Pharmacovigilance (PV) has been the rising regulatory star since the introduction of European Union (EU) legislation in 2012 which continues to be an inspiration for other regulatory authorities worldwide. Many authorities place a significant focus on PV inspections to ensure compliance and to implement enforcement measures, where necessary. This is...
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COVID-19 | Pharmacovigilance Update

In response to the COVID-19 pandemic, the Food and Drug Administration (FDA), European Medicine Agency (EMA) and other national health authorities have published guidelines and recommendations regarding post-authorisation Adverse Event (AE) reporting during this pandemic. This article provides a summary on global health authority expectations related to pharmacovigilance during the...
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How Can We Help

To find out more about what ADAMAS can do to support your audit program during these challenging times, please feel free to call us on +44 (0)1344 751 210 in Europe, +1-919-341-3361 in the US; or email us at info@adamasconsulting.com.

Stay Connected
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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