ADAMAS PODCAST

Welcome to the new ADAMAS Consulting Podcast series

DISCOVER REMOTE SERVICE OFFERINGS WITH ADAMAS

Listen to our experts discuss interesting topics from the challenges businesses are facing at this time, to solutions such as remote audits and other strategies that are helping keep our clients compliant. It’s a great way to gain some valuable knowledge and insights around all things Clinical Quality Assurance.

ADAMAS Podcast | Routine Data Assessment

Shehnaz Vakharia – Managing Director APAC
ADAMAS Consulting

The current global pandemic has created unprecedented challenges with onsite visits for monitoring and auditing. Overnight the industry is faced with challenges of setting a new normal while keeping the standards and quality intact and ensuring that the rights, safety and well-being of the trial subjects are protected.

This podcast discusses our Routine Data Assessments, which can assist sponsors in maintaining an adequate oversight of the quality and integrity of the data collected at Investigator Sites.

ADAMAS Podcast | Maintaining Inspection Readiness

Jessica Syverson – Consultant
ADAMAS Consulting

As regulatory authorities continue to outline their expectations for maintaining compliance during the pandemic, including the conduct of GxP inspections remotely, maintaining inspection readiness remains an important activity.

With our team of ex-inspectors, ADAMAS is well placed to assist with conducting mock inspections remotely.

ADAMAS Podcast | Maintaining Inspection Readiness

Jessica Syverson – Consultant
ADAMAS Consulting

As regulatory authorities continue to outline their expectations for maintaining compliance during the pandemic, including the conduct of GxP inspections remotely, maintaining inspection readiness remains an important activity.

With our team of ex-inspectors, ADAMAS is well placed to assist with conducting mock inspections remotely.

ADAMAS Podcast | Guidance On The Management Of Clinical Trials

Jessica Syverson – Consultant
ADAMAS Consulting

ADAMAS is delighted to present our Guidance for Clinical Trial Management, outlining the principal considerations for Sponsors and Investigator Sites and how your compliance activities can continue during this unprecedented time.

ADAMAS Podcast | A Novel Virus Needs A Novel Approach

Letaviah Thomas – Consultant
ADAMAS Consulting

We are focusing on new and innovative ideas on how to manage compliance during these challenging times. Our US Consultant Letaviah Thomas explains the ADAMAS approach. Regulatory Authorities have recently affirmed that GxP compliance and safety remain absolutely paramount even in the context of the COVID-19 pandemic. Given the extensive travel and other restrictions in place to control the spread of the virus, alternative approaches to routine regulatory oversight are needed.

ADAMAS Podcast | A Novel Virus Needs A Novel Approach

Letaviah Thomas – Consultant
ADAMAS Consulting

We are focusing on new and innovative ideas on how to manage compliance during these challenging times. Our US Consultant Letaviah Thomas explains the ADAMAS approach. Regulatory Authorities have recently affirmed that GxP compliance and safety remain absolutely paramount even in the context of the COVID-19 pandemic. Given the extensive travel and other restrictions in place to control the spread of the virus, alternative approaches to routine regulatory oversight are needed.

ADAMAS Podcast – COVID-19 | Conducting Remote Audits

Martina Vlkova – Senior Consultant
ADAMAS Consulting

Following the recent confirmation from Regulatory Authorities that GxP compliance should be maintained during the current COVID-19 pandemic, alternative approaches for routine regulatory oversight are needed. For ADAMAS, Remote Auditing represents the viable alternative during these unprecedented times.

COVID-19 | Remote Auditing – A Viable Alternative in Challenging Times

Jessica Syverson – Consultant
ADAMAS Consulting

ADAMAS have 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 oversight activities can continue. We are excited to bring to you our newest podcast which describes how ADAMAS can help you maintain compliance in line with current regulatory obligations.

COVID-19 | Remote Auditing – A Viable Alternative in Challenging Times

Jessica Syverson – Consultant
ADAMAS Consulting

ADAMAS have 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 oversight activities can continue. We are excited to bring to you our newest podcast which describes how ADAMAS can help you maintain compliance in line with current regulatory obligations.

ADAMAS Podcast – Mitigation and Management

Dr Patricia Fitzgerald – Executive Chairman
ADAMAS Consulting

Matt Barthel – Chief Technology Officer & DPO
ADAMAS Consulting

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.

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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

 

Please enter your details to complete the download.

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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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