Archives
- Presentations for the DIA EDM Conference “Electronic Document Management 2011: The Intersection of Data, Documents and Submissions” in Washington, DC
- Montrium Launches a SharePoint validation pack for regulatory compliance
- Montrium's SharePoint for Pharma webinar series is drawing large crowds
- Montrium launches a Series of Free Webinars on the use of SharePoint for Pharma
- Paul Fenton to present at the 46th Annual DIA Conference in Washington DC, June 2010
- Montrium presents at the ShareFest conference in Philadelphia - April 2010
- Paul Fenton to present at the 23rd Annual Electronic Document Management Conference in Washington DC on Feb 19th 2010
- eClinica and ClinVestigo Are Now Part of Montrium
Presentations for the DIA EDM Conference “Electronic Document Management 2011: The Intersection of Data, Documents and Submissions” in Washington, DC
Montrium had a large presence at this year’s annual DIA EDM conference in Washington, DC as three presentations where given by different members of Montrium’s management team. The presentations covered a wide range of topics related to the use of Electronic Document Management Systems within the context of regulated activities. The following sections provide an overview and a link to each the presentations:
“Leveraging Documentation Management Standards for Continuous Clinical Trial Process Improvement”
Presented by Paul Fenton, CEO
Learning Objectives:- Understand how to map document deliverables to process maps and metrics 2
- Understand mapping techniques and how these can be automated through workflow
- Understand the importance of document metadata and a workflow data to generate KPIs to measure performance
“The Deconstructed Workflow - Providing Flexibility to the Document Lifecycle Process”
Presented by Tevin Pathareddy, VP Technology
Learning Objectives:- Definition and implementation of an enterprise clinical taxonomy based on Industry Standards such as the TMF/EDM reference model and associated classification metadata
- Understand how technology can leverage a central taxonomy and classification metadata to automate the document lifecycle process from draft to records to submission
- How to implement holistic procedures which leverage standard templates, workflows, taxonomies and automated publishing tools to improve submission readiness
“Risk based approach to electronic document management system (EDMS) validation”
Presented by Michael Zwetkow, VP Operations
Learning Objectives:- To gain insight into the importance of adapting the risk based approach when validating an EDMS and integration of the EDMS with third party systems
- How to identify electronic records
- To understand the regulatory requirements (FDA & EMEA) that an EDMS must meet in order to ensure compliance
Montrium Launches a SharePoint validation pack for regulatory compliance
Montrium is pleased to announce that Montrium has developed SharePoint Validation Packs for SharePoint 2007 and 2010 to address the need to properly qualify the SharePoint system to meet the FDA's 21 CFR Part 11 requirements. All documents have been written using the GAMP 5 framework and will enable our clients to validate SharePoint quickly and cost effectively. In addition, Montrium also offers a validation pack for our partner Arx's CoSign solution for 21 CFR Part 11 compliant digital signatures. By combining these two validation packs our clients will easily be able to achieve a fully compliant environment for electronic records management.
To learn more, please click here to download our SharePoint Validation Pack information sheet or contact us on 514-223-9153 ext.206 or .
Montrium's SharePoint for Pharma webinar series is drawing large crowds
Montrium recently launched a series of free informative webinars which discuss the validation, deployment and use of SharePoint in GxP environments. There has been a lot of interest from industry in this subject and participants have provided very positive feedback on the quality of the presentations and content. If you were unable to participate in the initial webinars, you can watch the recorded webinars here. If you would like to register for the upcoming webinars in the series please visit our webinar webpage. Montrium will be launching a second series of webinars in the summer on using SharePoint for quality management. Details will be posted to our website shortly.
Montrium launches a Series of Free Webinars on the use of SharePoint for Pharma
Montrium will be presenting a series of informative webinars on the validation and use of SharePoint within regulated pharmaceutical environments. The first webinar will be presented by Paul Fenton, VP Pharmaceutical Processes and Technology on April 23rd. The webinar series will include the following subjects:
- April 23rd 2010 SharePoint and 21 CFR Part 11 – A risk based approach to validation for regulated environments
Presented by Paul Fenton, VP Pharmaceutical Processes and Technology, Montrium Inc. - May 7th 2010 Effective Configuration Control Techniques for Regulated SharePoint environments
Presented by Tevin Pathareddy, Pharmaceutical IT Project Leader, Montrium Inc. - May 21st 2010 Beyond Automation: Extracting Actionable Intelligence from SharePoint
Presented by Frédéric Landry, Pharmaceutical IT Consultant, Montrium Inc. - June 4th 2010 Managing and Maintaining the Validated State of GxP Applications Using SharePoint
Presented by Michael Zwetkow, Pharmaceutical IT Project Leader, Montrium Inc. - June 18th 2010 Going Paperless – Executing Validation of GxP Systems Electronically using SharePoint
Presented by Gianna De Rubertis, GxP Systems Validation Coordinator, Montrium Inc.
Paul Fenton to present at the 46th Annual DIA Conference in Washington DC, June 2010
Paul Fenton, VP Pharmaceutical Processes and Technology will be presenting a Knowledge Based Collaborative Model for the Rapid Integration of Platforms, People and Processes at the 46th Annual DIA Conference in Washington DC in June 2010. With his co-presenters, Paul will be discussing the use of industry metadata standards and collaborative systems for the implementation of BPM and BI. There will be specific focus on the application of these standards to the eTMF.
Montrium will also participate in the launch of the new DIA TMF Reference Model.
For more information, please visit 46th Annual DIA Meeting
Montrium presents at the ShareFest conference in Philadelphia - April 2010
Paul Fenton, Tevin Pathareddy and Fred Landry presented at the ShareFest Life Sciences conference this year in April in Philadelphia, PA. The conference was attended by 350 people from different areas of the industry. The following presentations were given:
- SharePoint and 21 CFR Part 11 – A risk based approach to validation for regulated environments
Presented by Paul Fenton, VP Pharmaceutical Processes and Technology
Click here to view a copy of the slides - Beyond Automation: Extracting Actionable Intelligence from Clinical Trials
Presented by Tevin Pathareddy and Fred Landry
Click here to view a copy of the slides
Paul Fenton to present at the 23rd Annual Electronic Document Management Conference in Washington DC on Feb 19th 2010
Paul Fenton, VP Pharmaceutical Processes and Technology will be presenting a Knowledge Based Collaborative Model for the Rapid Integration of Platforms, People and Processes at the 23rd Annual Electronic Document Management Conference in Washington DC on Feb 19th 2010. The following is an abstract of his presentation:
As Industry moves towards the implementation of a comprehensive set of systems for the conduct of clinical trials it is important to establish a set of standards for the integration and automation of these platforms and higher level processes and indicators. Through the alignment of technology with processes and the definition of clear metrics, we are able to gain better knowledge and control of the overall clinical trial process, allowing us to identify bottlenecks and make adjustments. This session concentrates on the use of Business Intelligence and Business Process Management software to integrate people, platforms and processes so as to better control the clinical trial process from synopsis to submission.
For more information, please visit 23rd Annual DIA EDM Conference
Montreal, April 24th , 2009
eClinica and ClinVestigo Are Now Part of Montrium
Montrium announces that as of April 24th 2009, eClinica and ClinVestigo have merged with Montrium with the goal of strengthening its position as a first-rate clinical consultancy services provider. Customers can now benefit from an expanded team of consultants with an even deeper pharmaceutical expertise, all from one source.
ClinVestigo was founded in 2001 as a pharmaceutical development consulting company specialized in regulatory compliance services, whereas eClinica has been providing professional consultancy services in electronic clinical trials since 2005.
Montrium is a knowledge-based company providing high-quality pharmaceutical services to the life sciences industry by combining pharmaceutical sciences and technologies. Montrium offers guidance and expertise to improve pharmaceutical research processes in the areas of strategic pharmaceutical IT management, process design and optimization as well as compliance and quality system management.
Montrium is committed to the promotion of innovation and advancement of research through the use of technology and scientific expertise. Please contact us to learn more about how Montrium’s expert consultants can help to improve the efficiency and productivity of your clinical trials and R&D processes.
