This presentation describes a case study of an eTMF structure, setup, and implementation at a biotechnology company currently conducting a pivotal Phase 3 clinical study in 70 centers worldwide.
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...Montrium
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Using Vault eTMF Milestones and EDLs to Support Inspection ReadinessVeeva Systems
Hear how Daiichi Sankyo is using milestones and expected document lists (EDLs) to enable ongoing inspection readiness and proactive TMF management and oversight.
Six Elements of the QC Process.
To learn more about the QC Process join us for a complimentary webinar ( March 29 @11am EST) where we will follow a TMF document through its life cycle from creation through inspection: Learn how TMF documents should maneuver through TMF submissions and quality checks utilizing well-developed processes, tools and metrics to ensure the TMF is ready when the inspectors come knocking.
Presented by: Jackie Morrill - Director of Clinical Operations
Register Here: http://bit.ly/2kqA6s8
Have full fleged clinical trial data management systems which bring them a good amount of business and revenue.
CDM is a fundamental process which controls data accuracy of each trial besides helping the timelessness to be achieved.
It helps in linking clinical research co-ordinator = who monitor all the sites & collects the data.
it Links with biostatisticians = who analyze, interpret and report data in clinically meaningful way.
A Trial Master File (TMF) is a comprehensive collection of essential documents and records that are generated or collected during the conduct of a clinical trial. The TMF serves as the centralized repository of all study-related documentation and provides a complete and accurate account of the trial's planning, execution, and outcomes. It is an important component of Good Clinical Practice (GCP) and regulatory compliance.
TMF Fundamentals - An Introduction to Better Trial Master File Management - M...Montrium
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Using Vault eTMF Milestones and EDLs to Support Inspection ReadinessVeeva Systems
Hear how Daiichi Sankyo is using milestones and expected document lists (EDLs) to enable ongoing inspection readiness and proactive TMF management and oversight.
Six Elements of the QC Process.
To learn more about the QC Process join us for a complimentary webinar ( March 29 @11am EST) where we will follow a TMF document through its life cycle from creation through inspection: Learn how TMF documents should maneuver through TMF submissions and quality checks utilizing well-developed processes, tools and metrics to ensure the TMF is ready when the inspectors come knocking.
Presented by: Jackie Morrill - Director of Clinical Operations
Register Here: http://bit.ly/2kqA6s8
Have full fleged clinical trial data management systems which bring them a good amount of business and revenue.
CDM is a fundamental process which controls data accuracy of each trial besides helping the timelessness to be achieved.
It helps in linking clinical research co-ordinator = who monitor all the sites & collects the data.
it Links with biostatisticians = who analyze, interpret and report data in clinically meaningful way.
A Trial Master File (TMF) is a comprehensive collection of essential documents and records that are generated or collected during the conduct of a clinical trial. The TMF serves as the centralized repository of all study-related documentation and provides a complete and accurate account of the trial's planning, execution, and outcomes. It is an important component of Good Clinical Practice (GCP) and regulatory compliance.
Life science companies expect electronic trial master file (eTMF) projects to provide greater efficiency, improve quality, increase standardization and enhance collaboration in TMF management. Join Paragon Solutions for the second session of our TMF webinar series to gain insights on the practical factors to consider when planning a new or improved future state eTMF. We'll share industry data on eTMF drivers, and discuss our definition of a robust eTMF. You'll learn why TMF information architecture is so critical to eTMF uptake and usability, and high level considerations for systems integration/migration. Finally, we'll define the maturity framework that allows for assessment of eTMF organizational readiness, a critical baseline to successful future state eTMF planning.
Review of essential documents (TMF BABE).Piyush Wagh
This ppt is useful for the Clinical Auditors (BABE), it helps in reviewing of essential documents and compilation of essential documents during clinical phase. Bioequivalence
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Clireo eTMF Solution by Arivis
What is Clireo?
• Comprehensive Software and Service enabling the Trial Master File
• Compliant with the DIA Trial Master File Reference Model Version 3
• Assign access and maintain control of Sites, Vendors, and Auditors for content.
• Eliminate CRA need to reconcile the Investigator Site File against the Sponsor TMF.
• Part 21 CFR 11 Digital signatures allow for faster turn around time on documents.
• Ability to quickly disseminate new information to users that the information is relevant to.
• Vendors and Sites can upload documentation and data directly into Clireo.
• Unlimited storage capacity assures that all documentation can be held in one location.
• No additional hardware required to implement.
• Dashboard reports on the status of sites and documents to easily identify missing or lagging information.
• Protect documents against unauthorized modification.
• Supports single or multiple file uploads with single screen metadata tagging.
• Centralized Documentation-Access from Anywhere.
• Resolve document issues faster.
• Ability to search documents in many ways.
• Dramatic Reduction in the need to print, scan, and store multiple copies in several locations.
• Link documents together to create a complete document package.
We have been serving eTMF customers since 2007.
Email now to schedule a demonstration and see how Clireo and Arivis can help you with your eTMF needs.
Tricia McQuarrie
Clinical Operations Manager tricia.mcquarrie@arivis.com
Arivis, Inc.
2198 E. Camelback Road
Phoenix, AZ 85016
Tel. 602-957-2150
www.m3.arivis.com
Practical Steps to Selecting and Implementing an eTMFMontrium
There are many benefits to moving to an electronic Trial Master File (eTMF) and many organizations are either thinking of moving, or are already in the process of doing so.
However, there are a great deal of things to consider before being able to successfully move to an electronic platform which are often overlooked, often resulting result in unsuccessful or sub-optimal eTMF implementations.
This webinar takes you through some of the practical steps that you need to go through to successfully implement and benefit from an eTMF.
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Since its release in 2010, The DIA’s TMF Reference Model has proven to be extremely valuable to the life sciences industry. In this content-packed webinar, we will provide a history and overview of the Model, present its structure, and the various sub-groups and resources available. The Model is not intended to be used “off-the-shelf" but can be implemented according to certain expectations and requirements of life science sponsors (pharma, bio, device), investigative sites (academic, for-profit, nonprofit) and CROs / third-party team members alike.
Paul Fenton, CEO of Montrium and CGI Life Science’s Fran Ross, both Members of the TMF Reference Model Steering Committee, will discuss strategies for implementing the Model and how it can be used to ensure tight controls of GxP required content for inspection. Finally, the session will present the TMF Reference Model Exchange Mechanism Standard which extends the Model's capability to facilitate eTMF interoperability and content exchange.
Visit:www.acriindia.com
ACRI is a leading Clinical data management training Institute in Bangalore India.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
clinical data management in clinical research, helpful for pharmacy, nursing, medical, health care providers, clinical research organization, PharmD, CROs, Clinical trial industry, human biomedical research.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
DIA Reference Model a Guidance for Good Document Management and eTMFSagar Ghotekar
The TMF Reference Model is managed under the Drug Information Association (DIA) Document and Records Management Community. The TMF Reference Model Provides Standardized Taxonomy and Metadata & outlines a reference definition of TMF content using standard Nomenclature.
Integrating Clinical Operations and Clinical Data Management Through EDCwww.datatrak.com
When electronic data capture was first introduced there was a great deal of discussion surrounding how the technology would alter the roles of those in clinical operations and clinical data management. Through the review of a case study, we will explore how EDC is used as a tool to more tightly integrate clinical operational staffs with those in clinical data management resulting in a more streamlined process from study initiation to database lock.
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
Life science companies expect electronic trial master file (eTMF) projects to provide greater efficiency, improve quality, increase standardization and enhance collaboration in TMF management. Join Paragon Solutions for the second session of our TMF webinar series to gain insights on the practical factors to consider when planning a new or improved future state eTMF. We'll share industry data on eTMF drivers, and discuss our definition of a robust eTMF. You'll learn why TMF information architecture is so critical to eTMF uptake and usability, and high level considerations for systems integration/migration. Finally, we'll define the maturity framework that allows for assessment of eTMF organizational readiness, a critical baseline to successful future state eTMF planning.
Review of essential documents (TMF BABE).Piyush Wagh
This ppt is useful for the Clinical Auditors (BABE), it helps in reviewing of essential documents and compilation of essential documents during clinical phase. Bioequivalence
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Clireo eTMF Solution by Arivis
What is Clireo?
• Comprehensive Software and Service enabling the Trial Master File
• Compliant with the DIA Trial Master File Reference Model Version 3
• Assign access and maintain control of Sites, Vendors, and Auditors for content.
• Eliminate CRA need to reconcile the Investigator Site File against the Sponsor TMF.
• Part 21 CFR 11 Digital signatures allow for faster turn around time on documents.
• Ability to quickly disseminate new information to users that the information is relevant to.
• Vendors and Sites can upload documentation and data directly into Clireo.
• Unlimited storage capacity assures that all documentation can be held in one location.
• No additional hardware required to implement.
• Dashboard reports on the status of sites and documents to easily identify missing or lagging information.
• Protect documents against unauthorized modification.
• Supports single or multiple file uploads with single screen metadata tagging.
• Centralized Documentation-Access from Anywhere.
• Resolve document issues faster.
• Ability to search documents in many ways.
• Dramatic Reduction in the need to print, scan, and store multiple copies in several locations.
• Link documents together to create a complete document package.
We have been serving eTMF customers since 2007.
Email now to schedule a demonstration and see how Clireo and Arivis can help you with your eTMF needs.
Tricia McQuarrie
Clinical Operations Manager tricia.mcquarrie@arivis.com
Arivis, Inc.
2198 E. Camelback Road
Phoenix, AZ 85016
Tel. 602-957-2150
www.m3.arivis.com
Practical Steps to Selecting and Implementing an eTMFMontrium
There are many benefits to moving to an electronic Trial Master File (eTMF) and many organizations are either thinking of moving, or are already in the process of doing so.
However, there are a great deal of things to consider before being able to successfully move to an electronic platform which are often overlooked, often resulting result in unsuccessful or sub-optimal eTMF implementations.
This webinar takes you through some of the practical steps that you need to go through to successfully implement and benefit from an eTMF.
In this presentation, we explore the TMF fundamentals and an introduction to better managing your TMF. We'll start by diving into the world of TMF management, how to properly leverage the regulations, which documents constitute as TMF-worthy and what basic metrics you can track to increase the efficiency of your trial.
Finally, we will also discuss some of the features Montrium has developed to facilitate the management of the Trial Master File in a fundamental way.
This presentation covers the following topics:
-Fundamentals of TMF management process
-How to use the regulations to ensure success
-What cross functional groups hold TMF worthy documents
-TMF management challenges and how you can alleviate them
-Base metrics to track and what they mean to your organization
-How an eTMF helps TMF Management
You can follow along with this presentation via our webinar:
https://info.montrium.com/tmf-fundamentals-an-introduction-to-better-trial-master-file-management
Since its release in 2010, The DIA’s TMF Reference Model has proven to be extremely valuable to the life sciences industry. In this content-packed webinar, we will provide a history and overview of the Model, present its structure, and the various sub-groups and resources available. The Model is not intended to be used “off-the-shelf" but can be implemented according to certain expectations and requirements of life science sponsors (pharma, bio, device), investigative sites (academic, for-profit, nonprofit) and CROs / third-party team members alike.
Paul Fenton, CEO of Montrium and CGI Life Science’s Fran Ross, both Members of the TMF Reference Model Steering Committee, will discuss strategies for implementing the Model and how it can be used to ensure tight controls of GxP required content for inspection. Finally, the session will present the TMF Reference Model Exchange Mechanism Standard which extends the Model's capability to facilitate eTMF interoperability and content exchange.
Visit:www.acriindia.com
ACRI is a leading Clinical data management training Institute in Bangalore India.
ACRI creates a value add for every degree. Our PGDCRCDM course is approved by the Mysore University. Graduates and Post Graduates and even PhDs have trained with us and got enviable positions in the Clinical Research Industry. ACRI supplements University training with Industry based training, coupled with hands-on internships and projects based on real case studies. The ACRI brand gives the individual the confidence and expertise to join the ever-growing workforce both in the country and abroad.
clinical data management in clinical research, helpful for pharmacy, nursing, medical, health care providers, clinical research organization, PharmD, CROs, Clinical trial industry, human biomedical research.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
DIA Reference Model a Guidance for Good Document Management and eTMFSagar Ghotekar
The TMF Reference Model is managed under the Drug Information Association (DIA) Document and Records Management Community. The TMF Reference Model Provides Standardized Taxonomy and Metadata & outlines a reference definition of TMF content using standard Nomenclature.
Integrating Clinical Operations and Clinical Data Management Through EDCwww.datatrak.com
When electronic data capture was first introduced there was a great deal of discussion surrounding how the technology would alter the roles of those in clinical operations and clinical data management. Through the review of a case study, we will explore how EDC is used as a tool to more tightly integrate clinical operational staffs with those in clinical data management resulting in a more streamlined process from study initiation to database lock.
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
Cloudbyz ppm, integrated enterprise ppm-alm-apm on force.comDinesh Sheshadri
Cloudbyz PPM is an integrated enterprise project portfolio management (PPM), application life cycle management (ALM) and application portfolio management (APM) built on Salesforce 1 platform. Cloudbyz PPM is focused on providing agility, real-time visibility and enhanced collaboration and productivity to CIO / IT organization.
Introducing PhlexEview 4: the latest version of our marketing leading, best of breed eTMF management technology. Now with more capabilities than ever to optimize TMF management, PhlexEview 4 adds intelligent new ways of working; designed specifically to enhance the user experience, maximize efficiency, facilitate compliance, and improve oversight
99+ Siebel CTMS Best Practices You Should FollowPerficient, Inc.
Companies that use Oracle’s Siebel Clinical Trial Management System (CTMS) should follow a set of best practices to enable users and administrators to operate efficiently. Best practices maximize the system’s functionality, maintain consistent business processes, and ensure clean records. In short, they save you time and money.
Perficient’s Param Singh, director of clinical trial management solutions, examined a variety of best practices that life sciences organizations should consider once they have implemented Siebel CTMS:
-SOPs, Work Practices and Administrative Functions
-Data Entry and Templates
-Protocols and Sites
-Reports and Queries
-Tips and Tricks
Centralized Translation Processes: Overcoming Global Regulatory and Multiling...Scott Abel
Presented by Inna Kassatkina at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis, IN.
Accurate translations of clinical trial documents play an important role in meeting global product demands. If not, mistakes from poorly done translations can result in product delays, cost overruns, or, even worse, contribute to malpractice or product liability lawsuits. Specifically, adhering to a documented process of free and informed consent as well as the proper translation of ICFs are crucial for protecting the subjects’ human rights. Communication problems and issues of true and informed consent may arise when a trial involves non-English speaking subjects. In this session, attendees learn to overcome the challenges of managing global content and to streamline and centralize the translation process.
* Managing Global Content: Specifically, in global clinical trials there is an overwhelming amount of information to manage. From source content creation to content management in multiple language, any life sciences professional involved in the global clinical trial process can benefit from project management approach to content management – from regulatory, financial, and efficiency perspectives.
* Streamlining Processes: Companies that are successful in managing translation of consent forms and other clinical trial materials, follow strict quality assurance procedures, be it with their on-staff translators or through a third-party translation agency. All documents are first translated, then edited, and finally proofread by experienced professional translators with clinical research background. In addition to that, translation memory tools are used, which reduce translation costs, ensure greater consistency of terminology throughout the document lifecycle, and contribute to faster turnarounds.
In MakroCare whitepaper, we have compiled and simplified some of these new policies, revisions, regulatory amendments from registration, labeling, safety reporting, renewal, publishing /eCTD submission of last year and forthcoming years.
SDL How Global Life Sciences Leaders Solve the Customer Experience PuzzleChip Gettinger
Having the right global customer experience strategy that fully integrates global product labeling interactions with real world patient care is critical for beating competitors and earning your customers’ loyalty.’
Providing SharePoint Solutions in an FDA Regulated EnvironmentDeb Walther
This talk explains to the IT Professional the reasons behind the FDA regulations and what must be considered when implementing SharePoint in a GxP environment.
Chemical inventory management is often a confusing and labor-intensive exercise. This webinar will shed light on how to build, operationalize, and improve a chemical inventory program. We will dissect the many nuances of a chemical inventory, and offer innovative, service-based solutions to help you successfully manage your chemical inventory program.
Chemical inventory management is often a confusing and labor-intensive exercise. This webinar sheds light on how to build, operationalize, and improve a chemical inventory program. We will dissect the many nuances of a chemical inventory, and offer innovative, service-based solutions to help you successfully manage your chemical inventory program.
Life sciences companies can avoid unnecessary risks and common sources of cost escalation by optimizing and centralizing the management of their promotional material references.
A Pharma/CRO Partnership in the Design and Execution of Paperless Clinical Tr...Target Health, Inc.
DIA 2019 presentation by Dr. Jules Mitchel with Michelle Eli (Lilly) and Tom Haag (ex-Novartis) based on their experience with Lilly collaborating on Target Health's paperless clinical trial system.
Curlew Research Brussels 2014 Electronic Data & Knowledge ManagementNick Lynch
Life Science externalisation and collaboration overview and the challenges that Life Science companies face in delivering successful data sharing with their partners in either Open Innovation or pre-competitive workflows
tranSMART Community Meeting 5-7 Nov 13 - Session 5: Recent tranSMART Lessons ...David Peyruc
tranSMART Community Meeting 5-7 Nov 13 - Session 5: Recent tranSMART Lessons Learned in Academic and Life Science Settings
Dan Housman, Recombinant by Deloitte
The Recombinant by Deloitte team has worked with organizations such as Kimmel Cancer Center as a model to adapt existing mature i2b2 implementations to meet business and scientific needs. Other organizations are increasingly focused on how to use cloud and high performance computing models to achieve different performance levels. Advanced initiatives are progressing to link commercial tools such as Qlikview to explore tranSMART data and to solve for key gaps in scientific pipelines. Dan will present recent lessons learned, new capabilities, and some of the impact on the path forwards for future tranSMART updates.
Tufts Research: Strategies from Data Management Leaders to Speed Clinical TrialsVeeva Systems
Watch the video here: https://bit.ly/3wChmGQ
Learn how top pharmas and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. In this webinar you'll gain insights into:
* Taking an agile approach to database build
* Reducing UAT timelines with a risk-based approach
* Driving innovation at your organization
This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times.
Meet Your Presenters:
Ken Getz
Director of Sponsored Programs, Tufts CSDD
Richard Young
Vice President, Vault EDC, Veeva Systems
Vertex Reduces EDC Study Build Times by 50%Veeva Systems
Watch the video here: https://bit.ly/3oUi6Vg
The clinical data team at Vertex asked themselves, how can we reduce our development timelines and costs—make things go faster, for less?
Answering those questions set Vertex on a path to challenge themselves and their vendors to improve speed without sacrificing quality. As a result, they’re reducing database build times by as much as 50% and reliably lock data in 15-18 days.
This webinar covers:
* How Vertex reaches 80-90% compliance with sites entering data within 2 days of the event
* Their #1 goal for transforming the UAT process
* Their novel recommendation for when to go live
* The technology strategy supporting their process improvements
Who Will Benefit:
* Clinical data executives
* Heads of clinical
* Heads of clinical research
Meet Your Presenters:
Vikas Gulati
Senior Director of Clinical Data Management and Metrics, Vertex Pharmaceuticals
Vikas Gulati has over 20 years’ experience focused on clinical data management, data standards and governance. He has led several global cross-functional teams to successful outcomes in Biotech/Pharma and CROs. He is currently the Global Head of Clinical Data Management at Vertex Pharmaceuticals, Inc.
Richard Young
Vice President, Vault EDC, Veeva Systems
Richard Young has nearly 25 years of expertise in data management, clinical solutions, and advanced clinical strategies. At Veeva, Young is establishing Vault EDC as the leading solution for clinical data management.
Michelle Harrison
Associate Director of Clinical Data Management and Metrics, Vertex
Michelle Harrison is currently working at Vertex Pharmaceutical in Boston Massachusetts as an Associate Director of Data Management. Prior to joining Vertex, she worked as a consultant for BioBridges. For 2 years there she consulted for a number of small Biotechs assisting with Vendor oversight and start up activities.
Similar to eTMF Structure, Setup, and Implementation Case Study (20)
In his public lecture, Christian Timmerer provides insights into the fascinating history of video streaming, starting from its humble beginnings before YouTube to the groundbreaking technologies that now dominate platforms like Netflix and ORF ON. Timmerer also presents provocative contributions of his own that have significantly influenced the industry. He concludes by looking at future challenges and invites the audience to join in a discussion.
Encryption in Microsoft 365 - ExpertsLive Netherlands 2024Albert Hoitingh
In this session I delve into the encryption technology used in Microsoft 365 and Microsoft Purview. Including the concepts of Customer Key and Double Key Encryption.
Pushing the limits of ePRTC: 100ns holdover for 100 daysAdtran
At WSTS 2024, Alon Stern explored the topic of parametric holdover and explained how recent research findings can be implemented in real-world PNT networks to achieve 100 nanoseconds of accuracy for up to 100 days.
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
Clients don’t know what they don’t know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clients’ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
State of ICS and IoT Cyber Threat Landscape Report 2024 previewPrayukth K V
The IoT and OT threat landscape report has been prepared by the Threat Research Team at Sectrio using data from Sectrio, cyber threat intelligence farming facilities spread across over 85 cities around the world. In addition, Sectrio also runs AI-based advanced threat and payload engagement facilities that serve as sinks to attract and engage sophisticated threat actors, and newer malware including new variants and latent threats that are at an earlier stage of development.
The latest edition of the OT/ICS and IoT security Threat Landscape Report 2024 also covers:
State of global ICS asset and network exposure
Sectoral targets and attacks as well as the cost of ransom
Global APT activity, AI usage, actor and tactic profiles, and implications
Rise in volumes of AI-powered cyberattacks
Major cyber events in 2024
Malware and malicious payload trends
Cyberattack types and targets
Vulnerability exploit attempts on CVEs
Attacks on counties – USA
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Cyber risk predictions
Axis of attacks – Europe
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Download the full report from here:
https://sectrio.com/resources/ot-threat-landscape-reports/sectrio-releases-ot-ics-and-iot-security-threat-landscape-report-2024/
PHP Frameworks: I want to break free (IPC Berlin 2024)Ralf Eggert
In this presentation, we examine the challenges and limitations of relying too heavily on PHP frameworks in web development. We discuss the history of PHP and its frameworks to understand how this dependence has evolved. The focus will be on providing concrete tips and strategies to reduce reliance on these frameworks, based on real-world examples and practical considerations. The goal is to equip developers with the skills and knowledge to create more flexible and future-proof web applications. We'll explore the importance of maintaining autonomy in a rapidly changing tech landscape and how to make informed decisions in PHP development.
This talk is aimed at encouraging a more independent approach to using PHP frameworks, moving towards a more flexible and future-proof approach to PHP development.
Communications Mining Series - Zero to Hero - Session 1DianaGray10
This session provides introduction to UiPath Communication Mining, importance and platform overview. You will acquire a good understand of the phases in Communication Mining as we go over the platform with you. Topics covered:
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My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
Why You Should Replace Windows 11 with Nitrux Linux 3.5.0 for enhanced perfor...SOFTTECHHUB
The choice of an operating system plays a pivotal role in shaping our computing experience. For decades, Microsoft's Windows has dominated the market, offering a familiar and widely adopted platform for personal and professional use. However, as technological advancements continue to push the boundaries of innovation, alternative operating systems have emerged, challenging the status quo and offering users a fresh perspective on computing.
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A tale of scale & speed: How the US Navy is enabling software delivery from l...sonjaschweigert1
Rapid and secure feature delivery is a goal across every application team and every branch of the DoD. The Navy’s DevSecOps platform, Party Barge, has achieved:
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- Maintenance of superior security standards and inherent policy enforcement with Authorization to Operate (ATO)
Development teams can ship efficiently and ensure applications are cyber ready for Navy Authorizing Officials (AOs). In this webinar, Sigma Defense and Anchore will give attendees a look behind the scenes and demo secure pipeline automation and security artifacts that speed up application ATO and time to production.
We will cover:
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Threats to mobile devices are more prevalent and increasing in scope and complexity. Users of mobile devices desire to take full advantage of the features
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Building better applications for business users with SAP Fiori.
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GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
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Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
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Climate Impact of Software Testing at Nordic Testing Days
eTMF Structure, Setup, and Implementation Case Study
1. A Case Study of an
eTMF Implementation
at a Small Biotech
Adair Turner, MSc, RAC
Regulatory Affairs Manager
Mission3, Inc.
2. Disclaimer
The views and opinions expressed in the following PowerPoint slides are
those of the individual presenter and should not be attributed to Drug
Information Association, Inc. (“DIA”), its directors, officers, employees,
volunteers, members, chapters, councils, Special Interest Area
Communities or affiliates, or any organization with which the presenter is
employed or affiliated.
These PowerPoint slides are the intellectual property of the individual
presenter and are protected under the copyright laws of the United States of
America and other countries. Used by permission. All rights reserved. Drug
Information Association, DIA and DIA logo are registered trademarks or
trademarks of Drug Information Association Inc. All other trademarks are
the property of their respective owners.
Drug Information Association www.diahome.org 2
3. Agenda
• This session provides a case study of an
eTMF implementation at a biotechnology
company currently conducting a pivotal
Phase 3 clinical study in 70 centers
worldwide.
• We will discuss our experience, process
management, and lessons learned.
Drug Information Association www.diahome.org 3
4. Problem
• Not enough resources!
• The logistics of managing
paper-based processes
with limited resources was
challenging,
overwhelming, and time
consuming.
• Documentation was “Welcome aboard, Bob.
inconsistent, incomplete, Your job is to figure out
what the heck happened
missing, expired, and/or here.”
redundant.
Drug Information Association www.diahome.org 4
5. Objective
• Prepare for an upcoming
NDA eCTD submission and
the subsequent GCP
inspection.
• Transform existing paper
based processes with a
centralized electronic
solution that would
maximize resources by
using a globally available
cloud-based framework.
Drug Information Association www.diahome.org 5
6. Partner’s System Requirements
• DIA TMF Reference Model utilization
– Clearly structured to account for documentation levels
and the trial complexity (global, country, site)
– The TMF RM is intended to provide a collaborative
advantage to stakeholders in creating and managing
their TMFs.
Drug Information Association www.diahome.org 6
7. Additional Requirements
• Software as a Service delivery model in which software
and associated data are centrally hosted in the cloud and
available globally
• Low cost and commitment
• Quickly and easily implemented
• Document management capabilities
– Check in/check out, version control, audit trail, work flows and
lifecycles, etc.
– Ability to use the same system for multiple projects
• Flexible
• Minimal validation required
Drug Information Association www.diahome.org 7
8. Program Plan - 5 Projects
1. eTMF Structure, Setup, and Implementation
2. Ongoing Clinical Trial Document Processing
3. Legacy Clinical Trial Data Processing
4. EDM Regulatory Structure, Setup, and Implementation
5. NDA Project Planning and eCTD Document Processing
Drug Information Association www.diahome.org 8
11. Technology Setup – 5 months
Drug Information Association 11
www.diahome.org
12. The Process - Partner
• CRA receives paper document(s) at site,
identifies/verifies content, completes
online transmittal form, assembles
document package, and ships document
package to Scanning Vendor
Drug Information Association www.diahome.org 12
15. eTMF Vendor QC Checklist
Verify:
•Page count
•Naming convention
•Metadata
•Location
Drug Information Association www.diahome.org 15
16. Documentation
• Partner audited both the Scanning Vendor and
the eTMF Vendor to ensure appropriate quality
documentation prior to signing.
• SOPs/Methodologies/Working Practices for
Scanning vendor, eTMF vendor, and Partner
company that cover each part of the process
• Appropriate and documented training
• Validation documentation
Drug Information Association www.diahome.org 16
17. Document Naming Convention
• Partner went through the DIA TMF RM and
added the naming convention they wanted for
each item.
Drug Information Association www.diahome.org 17
18. Metadata
• Beyond the metadata suggested by the DIA
TMF RM, we added a field for the unique
“Physical Document Locator” that corresponds
to the hard copy and wet signature if needed.
Drug Information Association www.diahome.org 18
19. Current Study
• We used the current Ph. 3 study as our
initial project and pilot.
• Together, we wrote, reviewed, and
implemented Scanning Methodology and
Work Practice documents.
• Scanned, indexed, and filed approximately
3500 documents in 6 months.
• Implemented EDMS for Regulatory
documents during this timeframe as well.
Drug Information Association www.diahome.org 19
20. Legacy Process
• More than 60,000 legacy documents were
shipped to scanning vendor (in 80 boxes).
• The shipment included a MS Excel
spreadsheet that listed the documents that
were in the boxes and was organized by
section of a previous Trial Master File and
by folder identifier.
• A new methodology document was written
for scanning the legacy documents.
Drug Information Association www.diahome.org 20
21. Legacy Study
• The Scanning Vendor had to do a great deal of
document reconciliation in order to index and
scan the documents and timelines were pushed
back by a couple of months.
• Legacy Study #1 contains approximately 26,500
documents and must be complete in 2 months!
• In order to meet timelines, documents must be
reviewed and filed in under 1 min each.
• A weekly status report is provided to our partner
showing the status of planned completion vs.
actual completion.
Drug Information Association www.diahome.org 21
22. Automated Metadata
• Scanning vendor indexed documents with
metadata provided on the Excel
spreadsheet.
• Text file indexes are uploaded with the PDF
documents to a secure SFTP site.
• The text file is used to populate the
document metadata as the documents are
automatically loaded into a “Staging Area.”
Drug Information Association www.diahome.org 22
24. How is it better?
• All study records are globally accessible, available and
organized. Partner is able to easily identify gaps and
assess completeness.
• New processes, standards and controls ensure increased
TMF quality.
• Time associated with file requests, audits, and
inspections have decreased. While the cost of mailing
documents, searching for information and reproducing
redundant documentation is significantly lowered.
Drug Information Association 24
25. Lessons Learned
• Establish paper document classification.
• Identify document naming conventions
and metadata early.
• Correspondence should be relevant and
organized.
• Planning and communication are the keys
to estimating and managing program
timelines.
Drug Information Association www.diahome.org 25
26. Let me know if you have any questions!
aturner@mission3.com
Drug Information Association www.diahome.org 26