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
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
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.
ADAMAS Podcast
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.