Sponsors and CROs must be assured that clinical data collected for regulatory submissions comply with the regulations and guidance around the world for data quality and integrity. Regulatory agencies are placing more emphasis on the voice of the patient, and they are auditing patient reported data for validity and trustworthiness. Intuitively, capturing patient data electronically instead of on paper would seem capable of providing valid data more reliably and efficiently. PHT has demonstrated that this is true.
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.
The specialized industry of collecting electronic patient-reported outcomes is increasing linearly, in part because global government regulators want to hear directly from the patient, and because the acceleration and availability of electronic collection (vs. paper collection) improves data quality and efficiencies for data analysis and trial management. This document will review the ePRO market, and outline the five ePRO methods what successfully support the collection of patient-reported data
The Certification team from ONC's Office of Standards & Interoperability will host an interactive session that provides information on the EHR Certification program and provides attendees the opportunity to ask questions and discuss thoughts with the panelists.
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.
The specialized industry of collecting electronic patient-reported outcomes is increasing linearly, in part because global government regulators want to hear directly from the patient, and because the acceleration and availability of electronic collection (vs. paper collection) improves data quality and efficiencies for data analysis and trial management. This document will review the ePRO market, and outline the five ePRO methods what successfully support the collection of patient-reported data
The Certification team from ONC's Office of Standards & Interoperability will host an interactive session that provides information on the EHR Certification program and provides attendees the opportunity to ask questions and discuss thoughts with the panelists.
The importance of learning how patients feel and function when taking a new clinical therapy has been acknowledged by the FDA, EMA and other global regulatory authorities. Sponsors currently engaged in drug development programs appreciate and leverage the added value of patient-reported outcome (PRO) data. They no longer ask if PROs should be collected, but what phase to begin PRO collection.
This issue of Insights is intended to identify the costs (delays and expenses) of collecting patient-reported outcomes on paper; and compare these against electronic PRO capture. The intention of this issue to provide clinical teams with industry data that can refute the presumption that paper methods are cheaper than ePRO.
Study start up activities in clinical data managementsoumyapottola
Study start-up (SSU) is so much more than a one-time document management exercise. It’s a global, strategic operation that can get new drugs approved faster – and it’s ripe for innovation – from Site Selection to Site Activation and Site Training.
Many SSU tech solutions deployed by sponsors don’t deliver the results promised because they add burden without benefits to clinical research sites. The result? Site staff simply avoid using them.
When that happens, document exchange and tracking falls back to paper, email and Excel formats – with CRAs holding the processes together. The tools that were supposed to solve a problem become part of the problem – and consume preThe implementation and conduct of a study can be a complex process that involves a
team from various disciplines and multiple steps that are dependent on one another. This
document offers guidance for navigating the study start-up processcious clinical trial budget.
A successful clinical study start-up is a crucial first step and an important factor for the overall success of the trial. For this reason, SCRO has experienced study start-up teams, offering customized services depending on your needs, whether it be fuWhile the definition varies across companies, study startup typically includes the process of identifying and qualifying sites, collecting essential documents at the study and site level, and submitting these documents for ethics approval. Successful study startup requires coordination between sites, sponsors, and contract research organizations (CROs) to achieve critical milestones in a compliant manner.ll-service or single activities.
How to achieve better time management in EDC start up
Clinical data management requires strict time management processes, especially in study start up within an electronic data capture (EDC) system. Three steps that clinical data management teams can take to outline the planning and executing of each task that needs to be considered are as follows:
Make a List: Create a daily or weekly task list and schedule when each task will be completed. This strategy will assist you in maintaining focus and staying organized.
Set realist goals: Be realistic about what you can finish in the amount of time you have. When setting unrealistic goals, failure is almost certain to follow.
Explore time-saving techniques: Examples of techniques that could help save time include grouping similar tasks together or using a timer to stay focused.
To help get started, here is a list of EDC considerations for Study Start-Up deadlines:
Protocol finalization and study enrollment
Split go-live considerations
eCRF Specification meetings (this will ensure proper collaboration and minimize any back-and-forth communication)
EDC add-on modules (which will be required and need validation?)
ePRO/eCOA used with licensed questionnaires.
IRB requirements for add-on modules (eConsent/ePRO)
Phụ lục 11 về Hệ thống máy tính trong bộ tiêu chuẩn GMP EU. Xem thêm các tài liệu khác trên kênh Slideshare của Công ty cổ phần Tư vấn thiết kế GMP EU.
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.
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 ...
Early diagnosis of infectious diseases and monitoring of community health are essential
for delivering cost-effective healthcare solutions. Healthcare delivery in developing coun-
tries have many challenges because they do not have enough resources for meeting the
healthcare needs, and they lack testing lab infrastructures in communities. It is necessary that a solution must be developed to safeguard the impacted communities. It has
been proven that Point-Of-Care (POC) testing can be considered as one of the ways to
resolve the crisis in healthcare delivery in these communities. The term 'POC testing'
has been used in many contexts. Use case, where a passenger in an autonomous vehicle
is driven to the nearest hospital for an emergency treatment due to an alert received by
the health monitoring system in the car. The POC that the research exploring is for
the use for a remote patient who does not have access to lab testing facilities because of
the social and economic conditions in that community.
The POC testing is a mission critical processes in which the patient conduct tests in a
home environment, as opposed to the tests undertaken otherwise in a laboratory facility
and it needs a communication system of architecture support which the research refers
as POCT system. The research looked at the requirements and made recommendations concerning critical aspects: requirements gathering for POCT system, design and
development methods of secure communication architecture, finding a suitable strategy
for testing the system and project managing the end-2-end process.
Data security is another critical factor in healthcare data. The research came up with
secure data communication architecture and processes for the system. A secure data
storage for the test results are needed, and the research came up with an architecture
for cloud storage. Deployment and expansion of the secure communication system are
essential for practical use cases based on community needs, and a scalable communication
architecture was developed to support the objective.
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.
Sponsors and regulators rely on the ePRO archive to prove that trial data are attributable and accurate; and that the trial can be reconstructed at any time. Any omissions can risk regulatory warnings, findings and possible data rejection. This issue describes the PTH ePRO Archive, and explains how and why it exceeds regulatory requirements and industry guidelines.
Here is our corporate profile, you will find information about all our solutions for vaccines clinical trials and also patient's programs. We have a variety of mobile and web apps that have been developed to enhance and improve your results in any clinical trial or patient care system.
Diabetes clinical research often includes PROs to measure symptoms and safety, evaluate quality of life, and record the economic burden. This edition of Insights highlights the conversion from paper to PRO for a PRO instrument designed to assess the impact of diabetes on the quality of life of patients with diabetes.
The purpose of this article is to provide Sponsors and CROs with a point-by-point review
of the differences between the Final FDA PRO Guidance and the Draft, highlighting the
choices made by FDA during the 3 years following the Draft PRO Guidance. These choices
reveal the FDA deliberations and resulting emphasis, and we also suggest in our review
what some of the differences might imply. Note that where terms appear highlighted
or emphasized in quotes from the Final Guidance, the emphasis has been done in the
original FDA document.
The importance of learning how patients feel and function when taking a new clinical therapy has been acknowledged by the FDA, EMA and other global regulatory authorities. Sponsors currently engaged in drug development programs appreciate and leverage the added value of patient-reported outcome (PRO) data. They no longer ask if PROs should be collected, but what phase to begin PRO collection.
This issue of Insights is intended to identify the costs (delays and expenses) of collecting patient-reported outcomes on paper; and compare these against electronic PRO capture. The intention of this issue to provide clinical teams with industry data that can refute the presumption that paper methods are cheaper than ePRO.
Study start up activities in clinical data managementsoumyapottola
Study start-up (SSU) is so much more than a one-time document management exercise. It’s a global, strategic operation that can get new drugs approved faster – and it’s ripe for innovation – from Site Selection to Site Activation and Site Training.
Many SSU tech solutions deployed by sponsors don’t deliver the results promised because they add burden without benefits to clinical research sites. The result? Site staff simply avoid using them.
When that happens, document exchange and tracking falls back to paper, email and Excel formats – with CRAs holding the processes together. The tools that were supposed to solve a problem become part of the problem – and consume preThe implementation and conduct of a study can be a complex process that involves a
team from various disciplines and multiple steps that are dependent on one another. This
document offers guidance for navigating the study start-up processcious clinical trial budget.
A successful clinical study start-up is a crucial first step and an important factor for the overall success of the trial. For this reason, SCRO has experienced study start-up teams, offering customized services depending on your needs, whether it be fuWhile the definition varies across companies, study startup typically includes the process of identifying and qualifying sites, collecting essential documents at the study and site level, and submitting these documents for ethics approval. Successful study startup requires coordination between sites, sponsors, and contract research organizations (CROs) to achieve critical milestones in a compliant manner.ll-service or single activities.
How to achieve better time management in EDC start up
Clinical data management requires strict time management processes, especially in study start up within an electronic data capture (EDC) system. Three steps that clinical data management teams can take to outline the planning and executing of each task that needs to be considered are as follows:
Make a List: Create a daily or weekly task list and schedule when each task will be completed. This strategy will assist you in maintaining focus and staying organized.
Set realist goals: Be realistic about what you can finish in the amount of time you have. When setting unrealistic goals, failure is almost certain to follow.
Explore time-saving techniques: Examples of techniques that could help save time include grouping similar tasks together or using a timer to stay focused.
To help get started, here is a list of EDC considerations for Study Start-Up deadlines:
Protocol finalization and study enrollment
Split go-live considerations
eCRF Specification meetings (this will ensure proper collaboration and minimize any back-and-forth communication)
EDC add-on modules (which will be required and need validation?)
ePRO/eCOA used with licensed questionnaires.
IRB requirements for add-on modules (eConsent/ePRO)
Phụ lục 11 về Hệ thống máy tính trong bộ tiêu chuẩn GMP EU. Xem thêm các tài liệu khác trên kênh Slideshare của Công ty cổ phần Tư vấn thiết kế GMP EU.
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.
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 ...
Early diagnosis of infectious diseases and monitoring of community health are essential
for delivering cost-effective healthcare solutions. Healthcare delivery in developing coun-
tries have many challenges because they do not have enough resources for meeting the
healthcare needs, and they lack testing lab infrastructures in communities. It is necessary that a solution must be developed to safeguard the impacted communities. It has
been proven that Point-Of-Care (POC) testing can be considered as one of the ways to
resolve the crisis in healthcare delivery in these communities. The term 'POC testing'
has been used in many contexts. Use case, where a passenger in an autonomous vehicle
is driven to the nearest hospital for an emergency treatment due to an alert received by
the health monitoring system in the car. The POC that the research exploring is for
the use for a remote patient who does not have access to lab testing facilities because of
the social and economic conditions in that community.
The POC testing is a mission critical processes in which the patient conduct tests in a
home environment, as opposed to the tests undertaken otherwise in a laboratory facility
and it needs a communication system of architecture support which the research refers
as POCT system. The research looked at the requirements and made recommendations concerning critical aspects: requirements gathering for POCT system, design and
development methods of secure communication architecture, finding a suitable strategy
for testing the system and project managing the end-2-end process.
Data security is another critical factor in healthcare data. The research came up with
secure data communication architecture and processes for the system. A secure data
storage for the test results are needed, and the research came up with an architecture
for cloud storage. Deployment and expansion of the secure communication system are
essential for practical use cases based on community needs, and a scalable communication
architecture was developed to support the objective.
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.
Sponsors and regulators rely on the ePRO archive to prove that trial data are attributable and accurate; and that the trial can be reconstructed at any time. Any omissions can risk regulatory warnings, findings and possible data rejection. This issue describes the PTH ePRO Archive, and explains how and why it exceeds regulatory requirements and industry guidelines.
Here is our corporate profile, you will find information about all our solutions for vaccines clinical trials and also patient's programs. We have a variety of mobile and web apps that have been developed to enhance and improve your results in any clinical trial or patient care system.
Diabetes clinical research often includes PROs to measure symptoms and safety, evaluate quality of life, and record the economic burden. This edition of Insights highlights the conversion from paper to PRO for a PRO instrument designed to assess the impact of diabetes on the quality of life of patients with diabetes.
The purpose of this article is to provide Sponsors and CROs with a point-by-point review
of the differences between the Final FDA PRO Guidance and the Draft, highlighting the
choices made by FDA during the 3 years following the Draft PRO Guidance. These choices
reveal the FDA deliberations and resulting emphasis, and we also suggest in our review
what some of the differences might imply. Note that where terms appear highlighted
or emphasized in quotes from the Final Guidance, the emphasis has been done in the
original FDA document.
Electronic Source (eSource) Data: Defined and Interpreted by Global Regulatory Authorities
Two recent regulatory publications from FDA and EMA address the topic of electronic source data in clinical investigations.
While the views are slightly different, these documents provide clarity concerning the expectations of regulatory authorities regarding electronic source data.
This Issue explores the topic of electronic source data and identifies some key concepts that are common (and seemingly agreed upon) within these publications.
The PRO Final Guidance announced December 2009 helps Sponsors and CROs understand how to include the patient viewpoint in the clinical trials that support market authorization for their medical products. The Guidance shows that FDA understands the pivotal role of PRO measures in establishing clinical benefit. This Insights edition is dedicated to ePRO mentioned within the Final Guidance, and intended to provide readers with an executive summary of the new document with respect to ePRO.
This issue includes an article entitled PHT Auditing, featuring Rod Thorell, Director of Quality Management & Compliance at PHT Corporation; an interview entitled Why Auditing is Critical to Sponsors with Laura Araujo, a Senior Consultant of Quality Management at Halloran Consulting Group; and a brief Question/Answer segment with Rod that reviews the contemporary issues of auditing, and explains what sponsors commonly ask of PHT’s auditing processes and procedures.
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.
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
➢FreenBecky 1st Fan Meeting in Vietnam
➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival
➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
➢ Vietnam Food Expo with Lotte Wellfood
"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
B2B payments are rapidly changing. Find out the 5 key questions you need to be asking yourself to be sure you are mastering B2B payments today. Learn more at www.BlueSnap.com.
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
The key differences between the MDR and IVDR in the EUAllensmith572606
In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).
https://mavenprofserv.com/comparison-and-highlighting-of-the-key-differences-between-the-mdr-and-ivdr-in-the-eu/
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
Company Valuation webinar series - Tuesday, 4 June 2024FelixPerez547899
This session provided an update as to the latest valuation data in the UK and then delved into a discussion on the upcoming election and the impacts on valuation. We finished, as always with a Q&A
VAT Registration Outlined In UAE: Benefits and Requirementsuae taxgpt
Vat Registration is a legal obligation for businesses meeting the threshold requirement, helping companies avoid fines and ramifications. Contact now!
https://viralsocialtrends.com/vat-registration-outlined-in-uae/
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
3. How you can capture more CRM data to understand your audience better through video testimonials. 📊
Improving profitability for small businessBen Wann
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How to Safeguard ePRO
1. 1
PHT Insights — Second Quarter 2009
Sponsors Deserve Trustworthy Patient Reported Outcomes
How PHT Safeguards Electronic Patient Reported Outcome (ePRO)
Data Collected from Global Clinical Trials
Sponsors and CROs must be assured that Since PHT collects and produces electronic records that become part of a submission to
clinical data collected for regulatory submis- global regulatory agencies, data on these electronic diaries (eDiaries) must be of high
sions comply with the regulations and guidance integrity and quality, and trustworthy sources of scienti c ndings. The PHT Quality
around the world for data quality and integrity. Management System (QMS) has been designed with safeguards that reach beyond
government requirements for safe data, secure data, archived and easily retrievable
Regulatory agencies are placing more emphasis
data. PHT is the only ePRO handheld eDiary provider with ISO 9001:2000 certi cation
on the voice of the patient, and they are auditing of its Quality Management System – one of the reasons why most of the world’s largest
patient reported data for validity and trust- pharmas choose PHT to collect ePRO data for their global studies.
worthiness. Intuitively, capturing patient data
electronically instead of on paper would seem T ensure that best practices are
To
capable of providing valid data more reliably Bene ts of ISO 9001:2000 Certi cation leveraged with each trial, PHT
and ef ciently. PHT has demonstrated that provides scienti c and technical
• Superior Product Quality review throughout the sales and
this is true.
• More Reliable Technology project development stages to
All PHT products meet the requirements of the help clients specify ePRO data
United States Food and Drug Administration • Ef cient Business Processes, Saving Time g
gathering requirements for
(FDA), the European Medicines Agency (EMEA), and Money e clinical trial. Once these
each
the European Union (EU), the International • Global and Repeatable Quality Standards d requirements have been
data
Conference on Harmonisation of Technical c rmed for a trial, PHT builds
con
Requirements for Registration of Pharmaceuti- • Continual Improvement of Processes a tests a prototype that is
and
s
shared with the client, and (1)
cals for Human Use (ICH), the Pharmaceuticals
makes changes to the ePRO
and Medical Devices Agency in Japan (PMDA), s
system based on review of the
and others. These regulations and guidelines prototype with th client, (2) translates diary screens with validated translation text,
t t ith the li t t l t di
are intended to ensure that the electronic systems (3) performs full validation and supports User Site Testing (UST) of the system with the
used in clinical research are safe and protected client, and (4) trains both sponsor and site personnel.
from tampering; that the electronic records such
as ePRO diaries are accurate, reliable, and PHT has four phases of internal processes and procedures that ensure that all eDiary
auditable; and that personal information of trial data are of the highest quality – whether collected by a mobile PDA for home entries,
or a touch-screen tablet PC for of ce entries.
subjects is protected.
This document describes how PHT provides data
security through its software applications, data
transmissions, physical data storage, database
1. PHT Electronic Mobile Devices are Con gured to Collect
and documentation backups, and audit trails. Clean Data.
To ensure that high quality data are captured on every eDiary, all PHT devices are
designed to verify date and time of data capture, and apply edit checks and logical
Contents branching. Once each eDiary is designed, PHT conducts extensive internal testing of
1. Con guration of each eDiary System p.1 each application, and documents conformance to the protocol requirements for data
capture. Internal tests of each device and ongoing calibrations during trial execution
2. Pre-Deployment Testing of Mobile Devices p.3 prevent discrepancies such as con icting time stamps per diary, incomplete diaries or
diaries that are out of sequence, or loss of data during transmissions regardless of line
3. Execution of Data Collection and Storage p.3
or signal quality. There are several product capabilities and PHT practices that enable
4. Real-Time Data Review and Archive p.4 all study con gurations to reach a high standard of data quality and integrity:
2. 2
PHT Insights – Second Quarter 2009
Sponsors Deserve Trustworthy Patient Reported Outcomes
Data entered are time- When a PHT mobile
stamped accurately. 5 Steps to Submissible Data device battery has run
PHT synchronizes study 1. 2. 3. 4. 5. low, the internal logic
server clocks hourly with PHT Scientific & ePRO Data ePRO Data Sites & Sponsors Archive of ensures that the device
US National Institute of Technical Teams Collected Transmitted to Authorize Real-Time Complete and clock is synchronized
Standards and Technol- Configure Mobile at Home or StudyWorks Access to Data Untampered XML in advance so that any
Devices to Collect at Site and Redundant Record Available
ogy (NIST) time serv- Clean Data Servers for Audit new data are accurate-
ers, and monitors the ly time stamped.
Authorized Queries
performance of its clocks
Time of data entry
to ensure that time server
can be scheduled.
disparities from the
Subjects using paper
NIST atomic clock never
diaries have long been
exceed 1 second. All
known to record data
PHT ePRO mobile device
in advance, or hours
clocks, which keep UTC,
or days after the time
are monitored for accu- Complete Complete Backup Confirmed
Transmissions required in the study
racy and resynchronized Confirmed
protocol schedule.
at each transmission
Retrospective reporting
when they connect to the
of symptom severity is
server. Daylight savings
of questionable value. Subjects may report past symptoms based on
rules and time zone offsets are updated when governments change
their current symptom experience. Using PHT ePRO provides certainty
them. PHT tracks such changes world wide and updates the tables in
that the report was done according to schedule. Such timely data have
our devices so that they consistently show correct local time computed
been reported to reveal ef cacy of medications with smaller sample
from an accurate UTC clock.
sizes than comparable data using paper methods where completion
Data are edit-checked. PHT can design ePRO questions to ensure that time was not enforced.
subjects cannot leave any required question unanswered, or enter
According to the FDA, “If a patient diary or some other
data that violate logic. Examples of edit-checking include only allowing
form of unsupervised data entry is used, the FDA plans to
digits (and not text) in responses that must be numerical, preventing
review the protocol to determine what measures are taken
entry of inappropriate dates in the future, and only allowing entry of
to ensure that patients make entries according to the study
blood pressure readings within the range that the measuring instru-
design and not, for example, just before a clinic visit when
ment can read.
their reports will be collected.” 1
Screens follow a logical branching sequence. In each eDiary,
subjects are automatically directed to the next logical question in order Devices and data can drive required activities. PHT devices sup-
to preclude entering inconsistent or con icting data. Subject comments port pre-programmed or conditional alarms to remind the subject
can be supported, but, unlike paper data methods where marginalia that it is time for data reporting or time to take medications or
can be abundant, comments such as “my hair hurts” can be limited treatments. All entries made on PHT devices include a date and
to particular screens for appropriate levels of review or simply time stamp to validate the timeliness of all captured data down to
prevented. the minute. Additionally, the PHT system can be set up to generate
automatic email alerts to sites and sponsors when subjects fail to
Data entry is restricted to authorized users. Each PHT mobile device
comply with the protocol, or when they report clinical conditions that
features logical protection with a unique encrypted and hidden pass-
merit site support.
word for sharing information with the PHT database via StudyWorks . In ®
addition, each device can support several levels of access controls cho- Data remain unchanged and protected from premature loss or
sen and/or entered by the subject (or other authorized person) to whom destruction. Government regulations require that sites prepare and
the particular device has been assigned. Access controls help ensure maintain source data. PHT enables site investigators to ful ll these
that captured data are fully attributable. For maximum data security, all requirements by protecting all original eDiary data in StudyWorks
exchanges of data during transmissions are encrypted and are compre- where authorized site personnel can access them at will, review
hensively logged on both StudyWorks and the mobile device to preserve them or cause them to be corrected. Full audit trail records are
the contextual information pertaining to each transmission.
1 Lines 334-337, ‘Guidance for Industry. Patient-Reported Outcome Measures: Use
Data are protected during battery removal, low voltage and
in Medical Product Development to Support Labeling Claims. DRAFT GUIDANCE.’ U.S.
device resets. Device monitoring logic ensures that devices operate
Department of Health and Human Services, Food and Drug Administration, Center for Drug
properly throughout the trial and prevents the possible corruption of
Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER),
results if batteries get too low or users trigger inappropriate resets.
Center for Devices and Radiological Health (CDRH). February 2006.
3. 3
PHT Insights – Second Quarter 2009
Sponsors Deserve Trustworthy Patient Reported Outcomes
automatically made of documents by the US
any changes to the data Federal Drug Administra-
after entry, including the tion on subject informed
retention of the original consent and subject
value, date/time stamp protection, Institutional
of the change, the iden- Review Boards (IRBs),
tity of the person who Investigational New
made the change, and Drug (IND) devices, and
the dated digital signa- adverse event reporting.
ture for attribution.
PHT has considered
Data remain
privacy protection a
con dential. Personal
design imperative for its
Data Protection is a
system. The mandates
universal Human Right,
of worldwide regulations
as af rmed in the PHT presence
are met and will continue
Universal Declaration
We’ll be to be met or exceeded
of Human Rights –
there soon by PHT’s Product Suite.
Article 12, and the
Unlike paper diary
Convention for the
collections, electronic
Protection of Human PHT and ePro Around the World
data capture increases
Rights and Fundamental • 60% of all PHT trials are international subject safety with real-
Freedoms – Article 8. • Language choices for subject and site – up to 16 on the same device time alerts for rescue
Multiple global agencies
• In-house production understands shipping and customs timelines medications and adverse
and regulations
events, and can do so
protect the security
without compromising
and con dentiality
privacy.
of electronic health information, with the authority to enforce
compliance with nes for breach, refusal to allow use of the data 2. PHT Electronic Mobile Devices Pass Strict
collected, and/or legal consequences. PHT is in full compliance with
regulations and guidelines for privacy of personal information for Internal Quality Testing Assurance Prior to
study staff and subjects. Trial Deployment.
The EU has created the broadest set of rules for protecting personal PHT conducts extensive internal validation testing of each device and
data, based on OECD guidelines. The EU Directive requires that study design, to ensure conformance to the protocol requirements for
data be (1) fairly and lawfully processed, (2) processed for limited data capture. To that end, the PHT study delivery function employs
purposes, (3) adequate, relevant and not excessive, (4) accurate more testers than developers (currently a 3:1 ratio).
and up-to-date, (5) not kept for longer than necessary, (6) processed As trial design engineers clarify protocol speci cations for a speci c
in line with the rights of data subjects, (7) secure, and (8) not trial and begin writing code, the PHT Software Quality Engineering
transferred to other countries without adequate protection. Many group develops appropriate test scripts. When completed, the test
countries follow the lead of the EU Directive for personal health data scripts are reviewed against the client requirements to ensure all
privacy. The United States seeks to protect data con dentiality at the required functionality is covered. Then they are used to test the study
National level with speci c data privacy rules in the US Health Insur- code and system operations to document that the system functions as
intended.
ance Portability and Accountability Act [HIPAA]; Japan’s Act of the
Protection of Personal Information is based on the 8 OECD criteria. In addition to internal Quality Control (QC ) testing, user site testing
The Asia-Paci c Economic Cooperation (APEC) 2005 framework is and database testing are undertaken for each trial. PHT project man-
also based on the OECD guidelines, and is being further developed. agers work with clients to assure adequate time for user site testing.
Turkey, Mexico, Israel, Dubai, China, India and Russia are preparing Sponsors who select vendors who do not conduct trial-speci c internal
data privacy laws. QC testing would be vulnerable under audit if asked to document that
an ePRO system was known to function as intended.
Subject or patient data are protected under The Declaration of Hel-
sinki, as developed by the World Medical Association (WMA), the ICH 3. Standard Procedures Ensure Reliable Data
Guidelines for Good Clinical Practice, the International Organization Collection, Transmission and Storage During
for Standardization (ISO) Clinical Investigation of Medical Devices for a Trial.
Human Subjects, the EU Good Clinical Practice Directive, and various
4. 4
PHT Insights – Second Quarter 2009
Sponsors Deserve Trustworthy Patient Reported Outcomes
PHT strictly enforces its policies and procedures for sion break. If interrupted, data are secured on the
secure data collection, communication and device and re-sent during a subsequent transmis-
data storage. All mobile devices are tested sion. Further, all wireless and analog devices
to ensure conformance to the protocol support automated retries and untended, scheduled
requirements for data capture. transmissions.
Collection of eDiary Data is Protected with The Physical Security of PHT Servers Ensures Safe
Electronic Safeguards. Data Storage. PHT acknowledges that any technol-
Sponsors must collect data that can be ogy leveraging mobile communications and the
authenticated and attributable. For this Internet is subject to potential attacks and
reason, each data entry response captured data tampering. As a result, PHT requires
on a PHT device is linked by documented physical security provisions as part of its
attribution steps to the particular subject security policy for the central electronic
assigned the device and, if required, also to systems and servers used in all clinical
the person who actually entered the report (a studies.
proxy or an observer). PHT supports linking
traditional handwritten signatures to ePRO All study servers are secured in a co-
records and still preserves con dentiality. location facility as well as at a facility near
or within the PHT of ces. PHT Corporation
Transmission of the eDiary Data to the selects its co-location facility based on
PHT Server is Reliable and Redundant.
Processes and methods ensure that data are documented physical security require-
securely, accurately and dependably transmitted ments, and audits providers against those
from the PHT mobile device to PHT StudyWorks. requirements. PHT also requires all key server
functions to be redundant.
Data are centralized and protected
against tampering. Transmissions from PHT Corporation selects its Physical security measures: Servers are located
the PHT mobile device to StudyWorks are co-location facility based on physical in locked facilities with environmental controls
encrypted and contain session logs that and emergency power, and contained in locked
are generated and monitored for all trans- security requirements, and ensures that
cabinets within a caged area in the facilities. Sur-
missions. All centralized data remains all key server functions are redundant. veillance cameras record activity throughout the
both physically and logically secure. XML facility 24x7. Main access points have redundant
source data are kept in encrypted packets
so that any change (e.g. tampering via back-end access) will break security measures, with security personnel onsite 24x7 365 days a
the encryption seal. PHT conducts regular tamper checks on all study year. Access to the servers is allowed for PHT authorized personnel
data. It also performs back end checks for duplicate records or only, with each such access logged (name and time) in records kept
inconsistent timestamps. for PHT to examine.
Data storage is redundant. PHT executes “full” database backups After archiving, all retired data are destroyed. All PHT devices are de-
daily, and keeps such backups securely offsite. Backups receive commissioned before they leave PHT, and contain no data. All hard
the same logical security measures as the live databases on serv- disks are destroyed or wiped to ensure that no identi able data are
ers. Backup media are “tamper evident”, with encrypted backups retained. Certi cation of destruction is provided for all devices, ac-
optionally supported. cording to the US Environmental Protection Agency (EPA) regulations,
Data are monitored. All captured data are reviewable only by the and all known other local and national mandates.
authorized StudyWorks users responsible for maintaining that data.
Typical roles include site coordinators, study monitors, data manage- 4. Security Measures for Real-Time Data
ment personnel and sponsor personnel, and each role has speci c Access and Archiving.
and different privileges for viewing or correcting data. During the web
browser login to StudyWorks, users must present a login ID that PHT Only authorized personnel can access StudyWorks to view reports or
validates to be different from all other users on all trials, and a hid- archival records. In addition, the StudyWorks server is dedicated ex-
den “strong” password (not known to PHT) of at least 8 characters. clusively for acting on data captured by the PHT mobile device, and
Sessions are encrypted under Secure Socket Layer (SSL) with 128 bit not used for any other purpose. Since StudyWorks is a web-based
encryption. Each server has a public key for its SSL encryption that is solution, web authorization and control of passwords are critical.
certi ed by a public company such as Verisign or Comodo. The PHT
servers are certi ed and are capable of issuing client certi cates Access to StudyWorks is protected by an administration module
for SSL sessions. Accurate data summaries and/or electronic Case with authorizations and passwords. Only users having security
Report Forms (eCRFs) for each captured report are viewable on Study- access to the Administrative Module for a study on the StudyWorks
Works for investigators with valid accounts who properly execute the Server can set up access privileges to that study for other users.
login procedure. Access to the Administrative Module is managed by authorized
Data transmission interruptions are managed. Data transmission specialists at PHT whose performance is regularly reviewed by the
procedures guard against data loss, even in the event of transmis- PHT Security of cer. These PHT specialists obtain from sponsors the