On the 28th of April, we conducted the webinar “Inspection Readiness: is your company ready?”, in collaboration with Agatha Inc.
During our webinar, we explored what it means when regulatory authorities require a clinical trial sponsor to maintain the Trial Master File in a state of “inspection readiness”.
We talked about the challenges of being inspection ready at all times, and discussed why that goal is essentially impossible without the use of an electronic Trial Master File (eTMF).
With the collaboration of one of our Partners, Agatha Inc., we looked at an example, and illustrated five specific ways that an eTMF helps ensure inspection readiness.
Watching the replay of the webinar, you will learn what you need to do to ensure your TMF content and data is ready whenever the auditors come.
Here are some of the questions we focused on answering:
- what do Regulatory Authorities mean by the requirement to be “Inspection Ready”?
- How does an eTMF solution ensure Inspection Readiness?
- What are the five key capabilities an eTMF must have to ensure Inspection readiness?
- What does it take to implement an eTMF application?
- How do you make the case for bringing an eTMF application into your organisation?
Speakers
Antonello Cervone
Senior Business and Technical Consultant at Arithmos
Antonello got a Master in Computer Science from the University of Rome “La Sapienza”. He has spent over 30 years in Information Technology and 20 years in the specific Pharmaceutical R&D domain.
During his experience, he had the opportunity to see both sides of the R&D process from a sponsor and vendors/service provider point of view, from working with CRO’s (Genexion), Pharma (Merck Serono, Menarini), Biotech (AB Science), Hospital (Bambino Gesù) and most recently with Arithmos as Senior Business and Technical Consultant.
He has a strong experience in Computerised Systems Validation: his first validated system was a pioneer eCRF developed in 1998.
He worked with FDA and EMEA (and other national authorities) for implementing the direct reporting of adverse events (ICH E2B) and clinical dossiers (eCTD, CDISC).
He also was involved in many client and authority audits by leading the IT and Data Management aspects.
Ken Lownie
General Manager US Operations at Agatha
Over a lengthy career at the intersection of software and life sciences, Ken has helped hundreds of pharma, biotech, and med device companies with technology strategy and implementation.
He is a big believer in the power of software to transform businesses but loves skewering overhyped technologies and complex platforms.
A graduate of Colgate University with a Masters in the Management of Technology from MIT, Ken deconstructs technical babble, helping his audiences and readers get to the heart of how software can solve their problems. Or at least some of them. But not the ones that include teenagers.
Robert Bokuniewicz
Customer Success Manager at Agatha
Robert is a systems implementation expert focused on Life Sciences content management solutions for the last 12 years. He has particular expertise in requirements analysis, project management, and services delivery.
About Arithmos
We help pharmaceutical, biotechnology, medical device, universities and non-profit organisations to achieve their results easier and smarter. We integrate the best solutions and technologies for our customers.
How can we help you?
We offer Business and Technology Consultancy Services for:
- eClinical
- Reporting & Analytics
- Regulated Document Management
- Pharmacovigilance and Safety
- Cloud Migration
Thanks to our Expertise and to our holistic approach, driven by our knowledge in clinical development and regulatory, we support your:
- Digital Transformation
- Business Process Re-engineering
- System Integration
- Data-Driven Management
