EDC provides significant benefits over paper-based clinical trials such as improved data quality, faster data availability, and better safety monitoring. A major biotechnology company migrated two large, international pivotal trials from paper to EDC to accelerate timelines and cut costs. They saw immediate benefits including elimination of queries of omission and the ability to proactively handle safety events. The database lock time was also significantly reduced from 8 weeks to 4 weeks. Staff preferred EDC and found it saved time and allowed earlier decision making.
Who needs fast data? - Journal for Clinical Studies KCR
How “no news” during the life of a trial is bad news, and what data management (among other things) can do to help when ensuring access to fast data? Get to know this and more about smart e-solutions in the newest article of Kaia Koppel, Associate Director, Biometrics & Clinical Trial Data Execution Systems at KCR, in the recent issue of Journal for Clinical Studies (p.40-21).
UpSkills: Research Data Management for the Sciencesstevage
A 2 hour introductory session presented to PhD students at the University of Melbourne, 13 September 2012.
Given by Steve Bennett (VeRSI) and Jeff Christiansen (ANDS).
Trials with patient reported endpoints are reporting increased efficiencies when using electronic patient reported outcomes (ePRO), compared to paper diary data collection methods. To date, approximately 20% of all trials with patient reported endpoints are using ePRO solutions to collect efficacy data. As the adoption of electronic patient reported outcomes continues to increase, sponsors are finding new ways to justify this technology’s ROI, and identify the types of trials that are best suited to ePRO (versus paper). This article will describe how several market-leading sponsors have quantified the benefits of better data quality, with case examples from recent trials implemented by PHT Corporation (PHT). These analyses are provided with the intention to inform the clinical research community, and provide the frameworks for further ROI determinations.
Who needs fast data? - Journal for Clinical Studies KCR
How “no news” during the life of a trial is bad news, and what data management (among other things) can do to help when ensuring access to fast data? Get to know this and more about smart e-solutions in the newest article of Kaia Koppel, Associate Director, Biometrics & Clinical Trial Data Execution Systems at KCR, in the recent issue of Journal for Clinical Studies (p.40-21).
UpSkills: Research Data Management for the Sciencesstevage
A 2 hour introductory session presented to PhD students at the University of Melbourne, 13 September 2012.
Given by Steve Bennett (VeRSI) and Jeff Christiansen (ANDS).
Trials with patient reported endpoints are reporting increased efficiencies when using electronic patient reported outcomes (ePRO), compared to paper diary data collection methods. To date, approximately 20% of all trials with patient reported endpoints are using ePRO solutions to collect efficacy data. As the adoption of electronic patient reported outcomes continues to increase, sponsors are finding new ways to justify this technology’s ROI, and identify the types of trials that are best suited to ePRO (versus paper). This article will describe how several market-leading sponsors have quantified the benefits of better data quality, with case examples from recent trials implemented by PHT Corporation (PHT). These analyses are provided with the intention to inform the clinical research community, and provide the frameworks for further ROI determinations.
Adaptive Real Time Data Mining Methodology for Wireless Body Area Network Bas...acijjournal
Since the population is growing, the need for high quality and efficient healthcare, both at home and in hospital, is becoming more important. This paper presents the innovative wireless sensor network based Mobile Real-time Health care Monitoring (WMRHM) framework which has the capacity of giving health predictions online based on continuously monitored real time vital body signals. Developments in sensors, miniaturization of low-power microelectronics, and wireless networks are becoming a
significant opportunity for improving the quality of health care services. Physiological signals like ECG, EEG, SpO2, BP etc. can be monitor through wireless sensor networks and analyzed with the help of data mining techniques. These real-time signals are continuous in nature and abruptly changing hence there is a need to apply an efficient and concept adapting real-time data stream mining techniques for taking intelligent health care decisions online. Because of the high speed and huge volume data set in data streams, the traditional classification technologies are no longer applicable. The most important criteria are to solve the real-time data streams mining problem with ‘concept drift’ efficiently. This paper presents the state-of-the art in this field with growing vitality and introduces the methods for detecting
concept drift in data stream, then gives a significant summary of existing approaches to the problem of concept drift. The work is focused on applying these real time stream mining algorithms on vital signals of human body in Wireless Body Area Network( WBAN) based health care environment.
Automating Clinical Trials in Pharmacology UnitsSGS
Electronic Data Capture (EDC) is now the preferred technology which provides significant benefits over traditional, manual data entry methods. In a recent guidance (Sept 2013) the FDA promotes capturing source data in electronic form, ensuring the reliability, quality, integrity, and traceability of data from electronic source all the way through to electronic regulatory submission.
The adoption of an eSource system to run a clinical pharmacology unit goes beyond simple EDC, it is about complete clinic automation. In this presentation we will share implementation experiences, benefits, and lessons learned while replacing paper source at the clinical unit through embedding eSource in all operational processes, from set-up of the eSource to delivery of SDTM compliant datasets.
Updated October 2014 with new figures.
The Amazing Ways Artificial Intelligence Is Transforming Genomics and Gene Ed...Bernard Marr
It is predicted that artificial intelligence (AI) will transform many aspects of our life including healthcare and genomics. AI and machine learning have helped us to understand the genome of organisms and will potentially change the way we treat disease, determine effective drugs and edit genes.
Presentation at NeHC: Overview of ONC's health information exchange standards-selection activities. Focuses on HITSC, the S&I Framework, and the S&I Query Health Initiative.
GxAlert for Real-time Management and Strengthening of Remote GeneXpert Networ...SystemOne
Real-time monitoring of GeneXpert machines can contribute to reduced error rates and shorter turnaround
times for module replacement and can improve the overall
maintenance of the machines. Emails and SMS alerts can speed
up treatment initiation. The NTP now gets SMS alerts and emails for DR-TB patient enrollment; stockout and error (>5%) rates; critical module errors; and monthly MDR reports to ensure better
connections among diagnosis, enrollment, and treatment.
The proliferation and global adoption of the Web is prompting biopharmaceutical decision makers to ask how the Internet can be leveraged to expedite clinical trials. It is reasonable to presume that large populations of patients are Web-savvy and that they have Internet access. As such, it is possible to leverage the Web as a mode of administration for entering electronic patient reported outcome data for clinical research. A key question many sponsors are asking is can the Web be used to collect patient reported outcomes that support label claims?
This article will describe the browser-based electronic patient reported outcome (ePRO) collection method. It will explain which types of trials are best suited for this type of data collection; discuss psychometric validations required with this collection modality; and explain how and when ePRO data collected via the web can support a claim.
As an expert provider of a wide spectrum of clinical development support services, KCR has developed
a supreme Data Management (DM) solution geared towards full data transparency as well as
delivering the highest level of quality within the defined timelines and in adherence to study budgets,
all the while ensuring the meeting of all Good Clinical Practice (GCP) and ICH requirements. Read our DM brochure and learn more about KCR DM capabilities.
EDC In Clinical Trials| Electronic Data Capture In Clinical Trialseclinicaltools
Unlock the transformative power of Electronic Data Capture (EDC) in clinical trials. EDC revolutionizes data management, ensuring real-time access, data accuracy, and streamlined processes. By replacing paper-based systems, it enhances efficiency, reduces errors, and expedites decision-making. Its adaptability facilitates various study designs, from traditional to decentralized trials. With features like remote monitoring and ePRO integration, EDC promotes patient-centricity. Embrace the future of clinical research, where EDC not only meets but exceeds the demands for precision, speed, and compliance, ultimately paving the way for more successful and patient-friendly trials.
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.
T R I A L M O N I T O R I N GQuality Remote Monitoring .docxssuserf9c51d
T R I A L M O N I T O R I N G
Quality Remote Monitoring:
The Tools of the Game
Penelope Manasco, MD
Outlining those technologies best able to raise the
data and process quality of risk-based monitoring.
A
critical aspect of risk-based monitoring
(RBM) is rapid access to a site’s clinical
data. In 2013, industry median values from
2009-2012 Phase II and III clinical trials (see
Figure 1 on facing page) showed that the
median time from electronic case report (eCRF)
entry to data manager query opened was 59 to 89
days. This is even more extraordinary when one
considers that the median time from subject visit
to query close (all queries including automatically
generated queries) ranged from 30 to 36 days.'
These findings emphasize that direct data en
try, either into the electronic data capture (EDC)
or eSource systems, provides significant value in
overseeing study conduct quality. Mitchel et al.2
reported on their experience implementing direct
data entry (DDE) and RBM in a clinical trial of 18
investigative sites in the U.S. and Canada study
ing 180 research subjects. In that trial, 92% of the
data was entered within one day of the subject
visit and 98% within eight days. Data review was
also faster with 50% of the data reviewed within 13
hours of data entry. Source data verification (SDV)
was completed at the site for approximately 20%
of the data within the EDC. There were changes on
0.8% of the pages, with the majority in three areas:
concomitant medications, medical history, and
clinical laboratory results.
The evidence above, coupled with the find
ing that SDV was not an adequate approach to
ensure trial quality,5 illustrates the importance of
technology and process changes that should be
implemented to enhance remote trial oversight
as envisioned by the FDA,2 European Medicines
Agency (EMA),5 and International Conference on
Harmonization (1CH) guidance6 documents on
RBM and quality management. The following tech
nology solutions can provide significant benefits
to implementing RBM and remote trial manage
ment.
Technology solutions
EDC and eSource
Direct data entry can be accomplished though
web-based EDC solutions and tablets, it is imper
ative that sites have adequate Internet access to
use tablets for direct data entry. Sites benefit from
eliminating transcription of documents. Moni
tors and data managers also benefit from having
immediate access to the data. Questions that
document good clinical practice (GCP) compli
ance can be incorporated into the EDC or eSource.
These fields (e.g„ detailing timing for vital signs,
informed consent processes) enable monitors to
conduct source data review remotely. Many data
managers may not be familiar with the additional
questions the monitor will want to have docu
mented, so cross-functional input into the EDC
is needed during design. Tablet setup and testing
ensures tablets work as needed by the site. The
initiation visit should i ...
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.
Evaluation of the importance of standards for data and metadata exchange for ...Wolfgang Kuchinke
Electronic Data Capture (EDC) in clinical research can ensure high-quality, clean data capture. Especially easy is the capture of repeating measurement like Adverse Events.
Here, a project is describes that evaluates the importance of data and metadata exchange for clinical research with the focus on EDC systems, standards that are relevant and the Computer System Validation (CSV) of EDC systems.
The project creats process descriptions, as well as necessary documents and checklists for any GCP-compliant system validation (Computer System Validation, CSV), like the Traceability Matrix.
Research networks are made aware of the necessity and importance of using EDC systems and conducting the computer system validation for regulatory compliance. The important role of CDISC standard, the standard for collection, exchange, submission to authorities and archiving of data from clinical studies is discussed in detail.
Adaptive Real Time Data Mining Methodology for Wireless Body Area Network Bas...acijjournal
Since the population is growing, the need for high quality and efficient healthcare, both at home and in hospital, is becoming more important. This paper presents the innovative wireless sensor network based Mobile Real-time Health care Monitoring (WMRHM) framework which has the capacity of giving health predictions online based on continuously monitored real time vital body signals. Developments in sensors, miniaturization of low-power microelectronics, and wireless networks are becoming a
significant opportunity for improving the quality of health care services. Physiological signals like ECG, EEG, SpO2, BP etc. can be monitor through wireless sensor networks and analyzed with the help of data mining techniques. These real-time signals are continuous in nature and abruptly changing hence there is a need to apply an efficient and concept adapting real-time data stream mining techniques for taking intelligent health care decisions online. Because of the high speed and huge volume data set in data streams, the traditional classification technologies are no longer applicable. The most important criteria are to solve the real-time data streams mining problem with ‘concept drift’ efficiently. This paper presents the state-of-the art in this field with growing vitality and introduces the methods for detecting
concept drift in data stream, then gives a significant summary of existing approaches to the problem of concept drift. The work is focused on applying these real time stream mining algorithms on vital signals of human body in Wireless Body Area Network( WBAN) based health care environment.
Automating Clinical Trials in Pharmacology UnitsSGS
Electronic Data Capture (EDC) is now the preferred technology which provides significant benefits over traditional, manual data entry methods. In a recent guidance (Sept 2013) the FDA promotes capturing source data in electronic form, ensuring the reliability, quality, integrity, and traceability of data from electronic source all the way through to electronic regulatory submission.
The adoption of an eSource system to run a clinical pharmacology unit goes beyond simple EDC, it is about complete clinic automation. In this presentation we will share implementation experiences, benefits, and lessons learned while replacing paper source at the clinical unit through embedding eSource in all operational processes, from set-up of the eSource to delivery of SDTM compliant datasets.
Updated October 2014 with new figures.
The Amazing Ways Artificial Intelligence Is Transforming Genomics and Gene Ed...Bernard Marr
It is predicted that artificial intelligence (AI) will transform many aspects of our life including healthcare and genomics. AI and machine learning have helped us to understand the genome of organisms and will potentially change the way we treat disease, determine effective drugs and edit genes.
Presentation at NeHC: Overview of ONC's health information exchange standards-selection activities. Focuses on HITSC, the S&I Framework, and the S&I Query Health Initiative.
GxAlert for Real-time Management and Strengthening of Remote GeneXpert Networ...SystemOne
Real-time monitoring of GeneXpert machines can contribute to reduced error rates and shorter turnaround
times for module replacement and can improve the overall
maintenance of the machines. Emails and SMS alerts can speed
up treatment initiation. The NTP now gets SMS alerts and emails for DR-TB patient enrollment; stockout and error (>5%) rates; critical module errors; and monthly MDR reports to ensure better
connections among diagnosis, enrollment, and treatment.
The proliferation and global adoption of the Web is prompting biopharmaceutical decision makers to ask how the Internet can be leveraged to expedite clinical trials. It is reasonable to presume that large populations of patients are Web-savvy and that they have Internet access. As such, it is possible to leverage the Web as a mode of administration for entering electronic patient reported outcome data for clinical research. A key question many sponsors are asking is can the Web be used to collect patient reported outcomes that support label claims?
This article will describe the browser-based electronic patient reported outcome (ePRO) collection method. It will explain which types of trials are best suited for this type of data collection; discuss psychometric validations required with this collection modality; and explain how and when ePRO data collected via the web can support a claim.
As an expert provider of a wide spectrum of clinical development support services, KCR has developed
a supreme Data Management (DM) solution geared towards full data transparency as well as
delivering the highest level of quality within the defined timelines and in adherence to study budgets,
all the while ensuring the meeting of all Good Clinical Practice (GCP) and ICH requirements. Read our DM brochure and learn more about KCR DM capabilities.
EDC In Clinical Trials| Electronic Data Capture In Clinical Trialseclinicaltools
Unlock the transformative power of Electronic Data Capture (EDC) in clinical trials. EDC revolutionizes data management, ensuring real-time access, data accuracy, and streamlined processes. By replacing paper-based systems, it enhances efficiency, reduces errors, and expedites decision-making. Its adaptability facilitates various study designs, from traditional to decentralized trials. With features like remote monitoring and ePRO integration, EDC promotes patient-centricity. Embrace the future of clinical research, where EDC not only meets but exceeds the demands for precision, speed, and compliance, ultimately paving the way for more successful and patient-friendly trials.
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.
T R I A L M O N I T O R I N GQuality Remote Monitoring .docxssuserf9c51d
T R I A L M O N I T O R I N G
Quality Remote Monitoring:
The Tools of the Game
Penelope Manasco, MD
Outlining those technologies best able to raise the
data and process quality of risk-based monitoring.
A
critical aspect of risk-based monitoring
(RBM) is rapid access to a site’s clinical
data. In 2013, industry median values from
2009-2012 Phase II and III clinical trials (see
Figure 1 on facing page) showed that the
median time from electronic case report (eCRF)
entry to data manager query opened was 59 to 89
days. This is even more extraordinary when one
considers that the median time from subject visit
to query close (all queries including automatically
generated queries) ranged from 30 to 36 days.'
These findings emphasize that direct data en
try, either into the electronic data capture (EDC)
or eSource systems, provides significant value in
overseeing study conduct quality. Mitchel et al.2
reported on their experience implementing direct
data entry (DDE) and RBM in a clinical trial of 18
investigative sites in the U.S. and Canada study
ing 180 research subjects. In that trial, 92% of the
data was entered within one day of the subject
visit and 98% within eight days. Data review was
also faster with 50% of the data reviewed within 13
hours of data entry. Source data verification (SDV)
was completed at the site for approximately 20%
of the data within the EDC. There were changes on
0.8% of the pages, with the majority in three areas:
concomitant medications, medical history, and
clinical laboratory results.
The evidence above, coupled with the find
ing that SDV was not an adequate approach to
ensure trial quality,5 illustrates the importance of
technology and process changes that should be
implemented to enhance remote trial oversight
as envisioned by the FDA,2 European Medicines
Agency (EMA),5 and International Conference on
Harmonization (1CH) guidance6 documents on
RBM and quality management. The following tech
nology solutions can provide significant benefits
to implementing RBM and remote trial manage
ment.
Technology solutions
EDC and eSource
Direct data entry can be accomplished though
web-based EDC solutions and tablets, it is imper
ative that sites have adequate Internet access to
use tablets for direct data entry. Sites benefit from
eliminating transcription of documents. Moni
tors and data managers also benefit from having
immediate access to the data. Questions that
document good clinical practice (GCP) compli
ance can be incorporated into the EDC or eSource.
These fields (e.g„ detailing timing for vital signs,
informed consent processes) enable monitors to
conduct source data review remotely. Many data
managers may not be familiar with the additional
questions the monitor will want to have docu
mented, so cross-functional input into the EDC
is needed during design. Tablet setup and testing
ensures tablets work as needed by the site. The
initiation visit should i ...
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.
Evaluation of the importance of standards for data and metadata exchange for ...Wolfgang Kuchinke
Electronic Data Capture (EDC) in clinical research can ensure high-quality, clean data capture. Especially easy is the capture of repeating measurement like Adverse Events.
Here, a project is describes that evaluates the importance of data and metadata exchange for clinical research with the focus on EDC systems, standards that are relevant and the Computer System Validation (CSV) of EDC systems.
The project creats process descriptions, as well as necessary documents and checklists for any GCP-compliant system validation (Computer System Validation, CSV), like the Traceability Matrix.
Research networks are made aware of the necessity and importance of using EDC systems and conducting the computer system validation for regulatory compliance. The important role of CDISC standard, the standard for collection, exchange, submission to authorities and archiving of data from clinical studies is discussed in detail.
Journal for Clinical Studies: The Changing Organisation and Data Management R...KCR
The wide range of data collection and management tasks has changed to better align with advancements in technology. Read KCR’s Joette Keen, Head of BMX, article on resource data management (DM) roles revisited for new optimisation, published in June issue of the Journal for Clinical Studies (p.44-45).
Dale W. Usner, Ph.D., President of SDC, co-authored the article "The Clinical Data Management Process," which was published in the November/December 2014 issue of Retina Today.
The article reviews the clinical data management (CDM) process in its entirety - from protocol review and CRF design through database lock. Describing the roles of various CDM team members and tips for efficient data management practices, "The Clinical Data Management Process" provides a comprehensive yet concise summary of this essential function in clinical trial research, specifically with respect to retina trials.
Database design in the context of Clinical Data Management (CDM) is a crucial aspect of organizing and managing clinical trial data effectively and efficiently. A well-designed database ensures that data collected during a clinical trial is accurate, consistent, and accessible, facilitating data analysis, reporting, and regulatory submissions. Clinical Data Management involves various steps, including data collection, validation, cleaning, and reporting
Considerations and challenges in building an end to-end microbiome workflowEagle Genomics
Many of the data management and analysis challenges in microbiome research are shared with genomics and other life-science big-data disciplines. However there are aspects that are specific: some are intrinsic to microbiome data, some are related to the maturity of the field, with others related to extracting business value from the data.
An brief introduction to the clinical data management process is described in this slides. These slides provides you the information regarding the data evaluation in the clinical trials , edit checks and data review finally data locking,then the data is submitted to the concerned regulatory body.
Streamlining Data Collection eCRF Design and Machine Learningijtsrd
Efficient and accurate data collection is paramount in clinical trials, and the design of Electronic Case Report Forms eCRFs plays a pivotal role in streamlining this process. This paper explores the integration of machine learning techniques in the design and implementation of eCRFs to enhance data collection efficiency. We delve into the synergies between eCRF design principles and machine learning algorithms, aiming to optimize data quality, reduce errors, and expedite the overall data collection process. The application of machine learning in eCRF design brings forth innovative approaches to data validation, anomaly detection, and real time adaptability. This paper discusses the benefits, challenges, and future prospects of leveraging machine learning in eCRF design for streamlined and advanced data collection in clinical trials. Dhanalakshmi D | Vijaya Lakshmi Kannareddy "Streamlining Data Collection: eCRF Design and Machine Learning" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63515.pdf Paper Url: https://www.ijtsrd.com/biological-science/biotechnology/63515/streamlining-data-collection-ecrf-design-and-machine-learning/dhanalakshmi-d
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.
Leverage Your EDC Solution to Mitigate Risk in Clinical Researchwww.datatrak.com
Every clinical trial is built upon a study protocol - the cornerstone of any trial. A well-defined and written study protocol provides the blueprint for the study, defining its purpose and goals. Studies have become more complex, creating more complicated study design, which can lead to making adherence more challenging for the study team and participants. The potential risk that some aspect of the study could be done incorrectly or not comply is inherent in all studies, but particularly present in complex research.
In order to help mitigate risk, advances in technology and the tools available today provide ways for us to mitigate some of the risk introduced in our clinical trials. While the study protocol is a cornerstone for the clinical trial, electronic data capture (EDC) applications have evolved in the broadest sense into technology solutions that provide us with a variety of tools to help mitigate risk.
Defining a Central Monitoring Capability: Sharing the Experience of TransCele...www.datatrak.com
Central monitoring, on-site monitoring, and off-site monitoring provide an integrated approach to clinical trial quality management. TransCelerate distinguishes central monitoring from other types of central data review activities and puts it in the context of an overall monitoring strategy. Any organization seeking to implement central monitoring will need people with the right skills, technology options that support a holistic review of study-related information, and adaptable processes. There are different approaches actively being used to implement central monitoring. This article provides a description of how companies are deploying central monitoring, as well as samples of the workflows that illustrate how some have implemented it. The desired outcomes include earlier, more predictive detection of quality issues. This paper describes the initial implementation steps designed to learn what organizational capabilities are necessary.
Technology Considerations to Enable the Risk-Based Monitoring Methodologywww.datatrak.com
TransCelerate BioPharma Inc developed a methodology based on the notion that shifting monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring will increase efficiencies and enhance patient
safety and data integrity while maintaining adherence to good clinical practice regulations. This philosophical shift in monitoring processes employs the addition of centralized and off-site mechanisms to monitor important trial parameters holistically, and it uses adaptive on-site monitoring to further support site processes, subject safety, and data quality. The main tenet is to use available data to monitor, assess, and mitigate the overall risk associated with clinical trials. Having the right technology is critical to collect and aggregate data, provide analytical capabilities, and track issues to demonstrate that a thorough quality management framework is in place. This paper lays out the high-level considerations when designing and building an integrated technology solution that will aid in scaling the methodology across an organization’s portfolio.
How To Optimize Your EDC Solution For Risk Based Monitoringwww.datatrak.com
This presentation presents best training practices to leverage EDC technology and risk-based monitoring to effectively and efficiently monitor clinical research.
Our focus is on the practical process of preparing your team to optimize the tools made available through an EDC solution.
This presentation is applicable to CRA’s, clinical project managers, clinical data managers, regulatory compliance professionals, and those involved in the design and implementation of risked-based monitoring plans.
View this recorded webinar to hear an overview of the Guidance Document on Electronic Source Data in Clinical Investigations and its practical implementation.
eSource: A Clinical Data Manager's Tale of Three Studieswww.datatrak.com
‘eSource: A Clinical Data Manager’s Tale of Three Studies’ highlights the challenges and benefits of eSource studies, and a look to the potential future. With the continuing adoption of eClinical solutions in clinical research, the need to understand, address, and utilize the time and cost savings benefits of eSource will grow increasingly important.
Use this template to create your Risk Based Monitoring guideline. Make sure you review this in conjunction with the Risk Based Monitoring in Practice presentation for the best possible result.
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
Niki Kutac, Director Product Management, delivered this presentation at the ACRP 2014 Conference where it was rated the #1 Session of the Event. Learn how to implement gamification to produce the desired end result.
Utilizing a Unified Platform to Bridge Geographical and Departmental Gaps Whi...www.datatrak.com
Presentation discusses:
The Drug Development Process
The Drug Development Paradox
Regulations and Guidelines
Standards - CDISC
Leveraging Technology
Resource Management
In the course of any clinical trial, there are risks associated with specific activities and tasks. This webinar will highlight some of these key risk areas and provide guidance on combining technology with best practices to help mitigate risks.
The FDA Guidance of a Risk-Based Approach to Monitoring as Viewed By CDMwww.datatrak.com
Historical Perspectives in CDM
Overview of the Draft Guidance
A Risked-Based Approach
Challenges to a Risk-Based Approach
Supporting a Risked-Based Approach
Connector Corner: Automate dynamic content and events by pushing a buttonDianaGray10
Here is something new! In our next Connector Corner webinar, we will demonstrate how you can use a single workflow to:
Create a campaign using Mailchimp with merge tags/fields
Send an interactive Slack channel message (using buttons)
Have the message received by managers and peers along with a test email for review
But there’s more:
In a second workflow supporting the same use case, you’ll see:
Your campaign sent to target colleagues for approval
If the “Approve” button is clicked, a Jira/Zendesk ticket is created for the marketing design team
But—if the “Reject” button is pushed, colleagues will be alerted via Slack message
Join us to learn more about this new, human-in-the-loop capability, brought to you by Integration Service connectors.
And...
Speakers:
Akshay Agnihotri, Product Manager
Charlie Greenberg, Host
LF Energy Webinar: Electrical Grid Modelling and Simulation Through PowSyBl -...DanBrown980551
Do you want to learn how to model and simulate an electrical network from scratch in under an hour?
Then welcome to this PowSyBl workshop, hosted by Rte, the French Transmission System Operator (TSO)!
During the webinar, you will discover the PowSyBl ecosystem as well as handle and study an electrical network through an interactive Python notebook.
PowSyBl is an open source project hosted by LF Energy, which offers a comprehensive set of features for electrical grid modelling and simulation. Among other advanced features, PowSyBl provides:
- A fully editable and extendable library for grid component modelling;
- Visualization tools to display your network;
- Grid simulation tools, such as power flows, security analyses (with or without remedial actions) and sensitivity analyses;
The framework is mostly written in Java, with a Python binding so that Python developers can access PowSyBl functionalities as well.
What you will learn during the webinar:
- For beginners: discover PowSyBl's functionalities through a quick general presentation and the notebook, without needing any expert coding skills;
- For advanced developers: master the skills to efficiently apply PowSyBl functionalities to your real-world scenarios.
Search and Society: Reimagining Information Access for Radical FuturesBhaskar Mitra
The field of Information retrieval (IR) is currently undergoing a transformative shift, at least partly due to the emerging applications of generative AI to information access. In this talk, we will deliberate on the sociotechnical implications of generative AI for information access. We will argue that there is both a critical necessity and an exciting opportunity for the IR community to re-center our research agendas on societal needs while dismantling the artificial separation between the work on fairness, accountability, transparency, and ethics in IR and the rest of IR research. Instead of adopting a reactionary strategy of trying to mitigate potential social harms from emerging technologies, the community should aim to proactively set the research agenda for the kinds of systems we should build inspired by diverse explicitly stated sociotechnical imaginaries. The sociotechnical imaginaries that underpin the design and development of information access technologies needs to be explicitly articulated, and we need to develop theories of change in context of these diverse perspectives. Our guiding future imaginaries must be informed by other academic fields, such as democratic theory and critical theory, and should be co-developed with social science scholars, legal scholars, civil rights and social justice activists, and artists, among others.
Key Trends Shaping the Future of Infrastructure.pdfCheryl Hung
Keynote at DIGIT West Expo, Glasgow on 29 May 2024.
Cheryl Hung, ochery.com
Sr Director, Infrastructure Ecosystem, Arm.
The key trends across hardware, cloud and open-source; exploring how these areas are likely to mature and develop over the short and long-term, and then considering how organisations can position themselves to adapt and thrive.
Slack (or Teams) Automation for Bonterra Impact Management (fka Social Soluti...Jeffrey Haguewood
Sidekick Solutions uses Bonterra Impact Management (fka Social Solutions Apricot) and automation solutions to integrate data for business workflows.
We believe integration and automation are essential to user experience and the promise of efficient work through technology. Automation is the critical ingredient to realizing that full vision. We develop integration products and services for Bonterra Case Management software to support the deployment of automations for a variety of use cases.
This video focuses on the notifications, alerts, and approval requests using Slack for Bonterra Impact Management. The solutions covered in this webinar can also be deployed for Microsoft Teams.
Interested in deploying notification automations for Bonterra Impact Management? Contact us at sales@sidekicksolutionsllc.com to discuss next steps.
JMeter webinar - integration with InfluxDB and GrafanaRTTS
Watch this recorded webinar about real-time monitoring of application performance. See how to integrate Apache JMeter, the open-source leader in performance testing, with InfluxDB, the open-source time-series database, and Grafana, the open-source analytics and visualization application.
In this webinar, we will review the benefits of leveraging InfluxDB and Grafana when executing load tests and demonstrate how these tools are used to visualize performance metrics.
Length: 30 minutes
Session Overview
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During this webinar, we will cover the following topics while demonstrating the integrations of JMeter, InfluxDB and Grafana:
- What out-of-the-box solutions are available for real-time monitoring JMeter tests?
- What are the benefits of integrating InfluxDB and Grafana into the load testing stack?
- Which features are provided by Grafana?
- Demonstration of InfluxDB and Grafana using a practice web application
To view the webinar recording, go to:
https://www.rttsweb.com/jmeter-integration-webinar
Kubernetes & AI - Beauty and the Beast !?! @KCD Istanbul 2024Tobias Schneck
As AI technology is pushing into IT I was wondering myself, as an “infrastructure container kubernetes guy”, how get this fancy AI technology get managed from an infrastructure operational view? Is it possible to apply our lovely cloud native principals as well? What benefit’s both technologies could bring to each other?
Let me take this questions and provide you a short journey through existing deployment models and use cases for AI software. On practical examples, we discuss what cloud/on-premise strategy we may need for applying it to our own infrastructure to get it to work from an enterprise perspective. I want to give an overview about infrastructure requirements and technologies, what could be beneficial or limiting your AI use cases in an enterprise environment. An interactive Demo will give you some insides, what approaches I got already working for real.
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
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).
Speakers:
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.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
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.
GraphRAG is All You need? LLM & Knowledge GraphGuy Korland
Guy Korland, CEO and Co-founder of FalkorDB, will review two articles on the integration of language models with knowledge graphs.
1. Unifying Large Language Models and Knowledge Graphs: A Roadmap.
https://arxiv.org/abs/2306.08302
2. Microsoft Research's GraphRAG paper and a review paper on various uses of knowledge graphs:
https://www.microsoft.com/en-us/research/blog/graphrag-unlocking-llm-discovery-on-narrative-private-data/
Essentials of Automations: Optimizing FME Workflows with ParametersSafe Software
Are you looking to streamline your workflows and boost your projects’ efficiency? Do you find yourself searching for ways to add flexibility and control over your FME workflows? If so, you’re in the right place.
Join us for an insightful dive into the world of FME parameters, a critical element in optimizing workflow efficiency. This webinar marks the beginning of our three-part “Essentials of Automation” series. This first webinar is designed to equip you with the knowledge and skills to utilize parameters effectively: enhancing the flexibility, maintainability, and user control of your FME projects.
Here’s what you’ll gain:
- Essentials of FME Parameters: Understand the pivotal role of parameters, including Reader/Writer, Transformer, User, and FME Flow categories. Discover how they are the key to unlocking automation and optimization within your workflows.
- Practical Applications in FME Form: Delve into key user parameter types including choice, connections, and file URLs. Allow users to control how a workflow runs, making your workflows more reusable. Learn to import values and deliver the best user experience for your workflows while enhancing accuracy.
- Optimization Strategies in FME Flow: Explore the creation and strategic deployment of parameters in FME Flow, including the use of deployment and geometry parameters, to maximize workflow efficiency.
- Pro Tips for Success: Gain insights on parameterizing connections and leveraging new features like Conditional Visibility for clarity and simplicity.
We’ll wrap up with a glimpse into future webinars, followed by a Q&A session to address your specific questions surrounding this topic.
Don’t miss this opportunity to elevate your FME expertise and drive your projects to new heights of efficiency.
Let's dive deeper into the world of ODC! Ricardo Alves (OutSystems) will join us to tell all about the new Data Fabric. After that, Sezen de Bruijn (OutSystems) will get into the details on how to best design a sturdy architecture within ODC.