“The only constant in life is change”-Heraclitus. This cannot be truer in today’s context.

In the past two decades, clinical research industry, has gone through a paradigm shift from the use of paper-based systems to web based electronic systems and from traditional 100 percent onsite monitoring to a combination of centralized statistical monitoring and reduced onsite visits.
The changes have been further compounded and accelerated by the COVID-19 Pandemic, wherein onsite visits for monitoring and auditing have become history.
Overnight the industry is faced with the challenge 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.

At ADAMAS, we are prepared for this challenge!

Our remote auditing and assessment options with the use of the latest available technology will ensure that you maintain a continuum in meeting your quality obligations. Our remote audits and assessments are carefully designed and customized to ensure that all aspects of processes and data required to protect the rights, safety and well-being of clinical trial subjects are covered by our highly experienced auditors conducting these services.

At ADAMAS we also have an observations database (Insights) which can analyse a sponsor’s risk areas from past studies and can be used to target quality audits on these areas in ongoing or future studies.

In addition, we conduct routine data assessments (RDAs) at a pre-determined frequency to assess the integrity of the data. The objectives of RDAs are to evaluate completeness, quality and timeliness of data reported to the Sponsor. RDAs involve review of datasets against key risk indicators (KRIs) and established quality tolerance limits (QTLs) to identify the data anomalies at subject/site/study levels, data integrity issues (audit trail, data corrections), high-risk areas/sites and systematic study level deviations.

Both the above approaches enable problems to be identified and resolved at an early stage before they become major or critical issues. Any serious issues identified during these assessments would lead to a remote site assessment initially and probably followed up by an on-site audit as permissible. The overall benefit of this approach is that quality can be monitored more frequently and only those sites where serious issues were observed would need to be audited, resulting in a more efficient use of available resources, and faster and more focused quality improvements.

“The problems we have today, cannot be solved by thinking the way we thought when we created them”. – Albert Einstein

Shehnaz Vakharia

Managing Director APAC
ADAMAS Consulting
Shehnaz.Vakharia@adamasconsulting.com

The ADAMAS Corporate Brochure 2016

 

Brochure – Please download the ADAMAS brochure describing our QA services and contact details.

×
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.

 

×
How to be a Clinical Auditor

So you want to be a Clinical Auditor? An article written by CEO.Dr.

×
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.

×

×
Is your QMS compliant?

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

×
ICH (E6) R2 Addendum - Step 4

 

Please enter your details to complete the download.

×

×
BECOME THE FIRST TO DISCOVER OUR DATA

Want to become one of the first businesses to access our exclusive data?
Get going and start reducing risk today. Pre register now.

×

×
How to be a Clinical Auditor

So you want to be a Clinical Auditor? An article written by CEO.Dr.


×

×