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.
FDA Audit Process Training using turtle diagrams presented by Rob Packard, founder of http://MedicalDeviceAcademy.com and Brigid Glass, CEO of Brigid Glass & Associates.
Changing Paradigms - The Evolution of Experiential Productionguest189bd31b
360e Productions' Founder and President, Chris Schultenover, was invited to participate in an Executive Briefing with Event Marketer entitled "Changing Paradigms - The Evolution of Experiential Production."
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 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.
FDA Audit Process Training using turtle diagrams presented by Rob Packard, founder of http://MedicalDeviceAcademy.com and Brigid Glass, CEO of Brigid Glass & Associates.
Changing Paradigms - The Evolution of Experiential Productionguest189bd31b
360e Productions' Founder and President, Chris Schultenover, was invited to participate in an Executive Briefing with Event Marketer entitled "Changing Paradigms - The Evolution of Experiential Production."
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 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 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.
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.
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.
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.
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.
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.
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.
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
Document Control Effectiveness in ISO 15189 Accredited Laboratoriesinventionjournals
ISO 15189 is the global quality management standard published by the International Organization for Standardization (ISO). Document control is one of the Key requirements of ISO 15189. It is considered Document control is the major quality element to establish a quality management system. The research study was carried out to understand the effectiveness of a document control system followed in accredited medical laboratories. It was the key objective to identify the importance of document control system hypothesis vs practical implementation and Challenges of Document control system implementation. It was really hard to categorize the implementation status of document control, but I have tried to analyze it. In the study volume of up to date control document usage in functional area is estimated. Various effects of document control are also analyzed before implementing the accreditation system and post accreditation system. A structured document control system is also observed and compared with pre and the post accreditation system. In the study all reported events are analyzed to find out out the reported event in related to document control system. Risk analysis of document used in the laboratory is also analyzed. Total risk scoring is done based on the document risk involvement. Major challenges observed in the manual document control system. A suggestive idea is prescribed in the improvement of a document control system.
Effectiveness of ISO 15189 2012: a requirement for medical laboratories with ...iosrjce
IOSR Journal of Business and Management (IOSR-JBM) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of business and managemant and its applications. The journal welcomes publications of high quality papers on theoretical developments and practical applications inbusiness and management. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
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.
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.
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.
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.
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.
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.
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.
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
Document Control Effectiveness in ISO 15189 Accredited Laboratoriesinventionjournals
ISO 15189 is the global quality management standard published by the International Organization for Standardization (ISO). Document control is one of the Key requirements of ISO 15189. It is considered Document control is the major quality element to establish a quality management system. The research study was carried out to understand the effectiveness of a document control system followed in accredited medical laboratories. It was the key objective to identify the importance of document control system hypothesis vs practical implementation and Challenges of Document control system implementation. It was really hard to categorize the implementation status of document control, but I have tried to analyze it. In the study volume of up to date control document usage in functional area is estimated. Various effects of document control are also analyzed before implementing the accreditation system and post accreditation system. A structured document control system is also observed and compared with pre and the post accreditation system. In the study all reported events are analyzed to find out out the reported event in related to document control system. Risk analysis of document used in the laboratory is also analyzed. Total risk scoring is done based on the document risk involvement. Major challenges observed in the manual document control system. A suggestive idea is prescribed in the improvement of a document control system.
Effectiveness of ISO 15189 2012: a requirement for medical laboratories with ...iosrjce
IOSR Journal of Business and Management (IOSR-JBM) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of business and managemant and its applications. The journal welcomes publications of high quality papers on theoretical developments and practical applications inbusiness and management. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Keynote speakers SEC Commissioner Luis Aguilar and PCAOB Chairman James Doty set the tone for the conference by calling upon accountants, as financial statement preparers and auditors, to step up to their special responsibility to strengthen investor confidence in financial reporting and thereby help keep the markets trustworthy and safe for investors.
As a background for the discussions, Commissioner Aguilar cited studies showing startling declines in market statistics: Only 17% of Americans trust the stock market. Average daily trades in US stocks are only about half their 2008 peak. US initial public offerings of smaller companies have never fully recovered following the bursting of the technology bubble in 2000.
To restore the vitality of the markets, Commissioner Aguilar said, individual investors must have confidence that the markets are fair, the rules are enforced effectively, and the information available is meaningful, accurate and complete. There can be no doubt in the hearts and minds of investors about the reliability and integrity of the audited financial statements.
An internal audit is designed to review what a company is doing in order to identify potential threats to the organization's financial health and profitability and to make suggestions for mitigating the risk associated with those threats.
quality audit is essential for every organization . It discover the draw backs and then by improving this we can grow .It provide high degree of confidence.
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.
Elevating Tactical DDD Patterns Through Object CalisthenicsDorra BARTAGUIZ
After immersing yourself in the blue book and its red counterpart, attending DDD-focused conferences, and applying tactical patterns, you're left with a crucial question: How do I ensure my design is effective? Tactical patterns within Domain-Driven Design (DDD) serve as guiding principles for creating clear and manageable domain models. However, achieving success with these patterns requires additional guidance. Interestingly, we've observed that a set of constraints initially designed for training purposes remarkably aligns with effective pattern implementation, offering a more ‘mechanical’ approach. Let's explore together how Object Calisthenics can elevate the design of your tactical DDD patterns, offering concrete help for those venturing into DDD for the first time!
Builder.ai Founder Sachin Dev Duggal's Strategic Approach to Create an Innova...Ramesh Iyer
In today's fast-changing business world, Companies that adapt and embrace new ideas often need help to keep up with the competition. However, fostering a culture of innovation takes much work. It takes vision, leadership and willingness to take risks in the right proportion. Sachin Dev Duggal, co-founder of Builder.ai, has perfected the art of this balance, creating a company culture where creativity and growth are nurtured at each stage.
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.
Dev Dives: Train smarter, not harder – active learning and UiPath LLMs for do...UiPathCommunity
💥 Speed, accuracy, and scaling – discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Mining™:
See how to accelerate model training and optimize model performance with active learning
Learn about the latest enhancements to out-of-the-box document processing – with little to no training required
Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
This is a hands-on session specifically designed for automation developers and AI enthusiasts seeking to enhance their knowledge in leveraging the latest intelligent document processing capabilities offered by UiPath.
Speakers:
👨🏫 Andras Palfi, Senior Product Manager, UiPath
👩🏫 Lenka Dulovicova, Product Program Manager, UiPath
SAP Sapphire 2024 - ASUG301 building better apps with SAP Fiori.pdfPeter Spielvogel
Building better applications for business users with SAP Fiori.
• What is SAP Fiori and why it matters to you
• How a better user experience drives measurable business benefits
• How to get started with SAP Fiori today
• How SAP Fiori elements accelerates application development
• How SAP Build Code includes SAP Fiori tools and other generative artificial intelligence capabilities
• How SAP Fiori paves the way for using AI in SAP apps
Accelerate your Kubernetes clusters with Varnish CachingThijs Feryn
A presentation about the usage and availability of Varnish on Kubernetes. This talk explores the capabilities of Varnish caching and shows how to use the Varnish Helm chart to deploy it to Kubernetes.
This presentation was delivered at K8SUG Singapore. See https://feryn.eu/presentations/accelerate-your-kubernetes-clusters-with-varnish-caching-k8sug-singapore-28-2024 for more details.
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
Clients don’t know what they don’t know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clients’ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
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/
Observability Concepts EVERY Developer Should Know -- DeveloperWeek Europe.pdfPaige Cruz
Monitoring and observability aren’t traditionally found in software curriculums and many of us cobble this knowledge together from whatever vendor or ecosystem we were first introduced to and whatever is a part of your current company’s observability stack.
While the dev and ops silo continues to crumble….many organizations still relegate monitoring & observability as the purview of ops, infra and SRE teams. This is a mistake - achieving a highly observable system requires collaboration up and down the stack.
I, a former op, would like to extend an invitation to all application developers to join the observability party will share these foundational concepts to build on:
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.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...
ePRO: Objective Patient Data Collection
1. PHT Insights — Third Quarter 2009
PHT Auditing Quality & Compliance
Objective Evidence that Data Collection Processes
Operate Within Established Policies and Procedures
This issue includes an article entitled PHT Auditing, written by Rod Thorell who
Last quarter’s Insights Issue focused is Director of Quality Management & Compliance at PHT Corporation; an interview
on data quality, security and privacy entitled Why Auditing is Critical to Sponsors with Laura Araujo who is a Senior
matters, describing ‘How PHT Safeguards Consultant of Quality Management at Halloran Consulting Group; and a brief
Electronic Patient Reported Outcome Question/Answer segment with Rod Thorell that reviews the contemporary
(ePRO) Data Collected from Global issues of auditing, and explains what sponsors commonly ask of PHT’s
Clinical Trials’. auditing processes and procedures.
Similar to data security, PHT’s product
suite is compliant with all archival
requirements of Regulations and
Guidance in the US, Japan and the
Trust, but Verify–Russian Proverb
European Union, as described in this Issue. PHT Auditing by Rod Thorell
Director, Quality Management & Compliance
Core to the founding principles of PHT, PHT Corporation
September 2009
data quality, has been under the mandate
of the company’s Chief Executive Recently, I was teaching one of my children how to
responsible for the scientific integrity make a cake from scratch. As we put together all the
of PHT’s product suite–Steve Raymond, ingredients, he grabbed a large container of what he
Ph.D., Founder, Chief Scientific and thought was sugar. “Before you put it in,” I told him,
“make sure you know what you have.” It was a simple
Quality Officer. Our thanks to Steve for
test to put a few of the little white granules on the tip of a finger then touch them
his continuing contributions to PHT
to the tongue. Instantly, it became obvious to him that it was salt, not sugar.
Insights, his insistence that technology They look a lot alike, but have very, very different properties. I dare say that
serve science, cake would not have been very palatable with a half cup of salt. Even though he
and for his thought he was doing the right thing and everything appeared to be in order, a
lasting gifts second person checking his process averted a certain disaster.
and direction In any business, there are hundreds of processes that occur every day; some as
to the clinical simple as baking a cake, some very complex involving people inside and outside
and scientific the organization, crossing departmental functions and utilizing software or tools.
industry The role of auditing is to
at large. Contents provide objective evidence
PHT Auditing p.1 that all those processes are
Steve Raymond, Ph.D. running according to the
PHT Founder, Chief Scientific and Quality Officer Interview with Rod Thorell p.3 policies and procedures
PHT Corporation
Interview with Laura Araujo p.4 put in place. Objective
evidence gained about a
2. 2
PHT Insights – Third Quarter 2009
PHT Auditing and Quality Compliance
participate in a full day of auditor training,
led by a certified lead auditor. At the conclu-
sion of the day, each new auditor is assigned
an area or process to audit alongside an
experienced auditor. When the audit report
is completed, a second audit is planned
with support from the Director of Quality and
Compliance. After this second audit is com-
pleted and reviewed, the training certificate
is issued and they are considered to be an
official internal auditor.
External Audits Confirm ISO9001:2000
Certification The PHT internal audit program
is reviewed during the annual surveillance
audit from the ISO9001:2000 registrar.
This third party inspection peers into our
processes, including the processes we use
to manage our internal audits. Every three
process allows you to make informed decisions about quality years, we undergo a more rigorous re-certification audit that
of the final output. By proactive examination, we can identify involves multiple auditors at our operation for several days.
potential weaknesses and address them before they cause PHT has passed this re-certification audit of our quality systems
nonconformity (also known as Preventive Action). Proactively and processes twice, maintaining continual ISO9001:2000 cer-
strengthening processes are a key part of continual improvement tification since December, 2002. PHT’s continual certification
of the PHT Quality Management System. is important, because we are required to pass the inspection
PHT Internal Audits provide PHT of our quality system and demonstrate continual improvement
managers with information on “The role of from year to year. We must demonstrate with concrete evidence
the following three aspects of that we have a good system that is always getting even better.
auditing is to
their systems: provide objective PHT Audits Every Clinical Trial An audit is performed against
• Adequacy: Do PHT’s systems, evidence that all every clinical trial PHT executes. This allows us to ensure
as they are designed, have the those processes consistency in our practices, including project management,
potential to succeed? software development and document handling. The final
are running
archive for each trial is audited to ensure our customers will
• Implementation: Are PHT’s according to
have all the necessary evidence to allow evaluation of the conduct
systems being implemented as the policies and and data of the trial so that regulatory authorities can easily deem
designed? procedures put the trial records to be trustworthy.
• Effectiveness: Are PHT’s systems in place.”
Corrective and Preventative Action Process While proactively
achieving their intended results? monitoring processes strengthen PHT systems, from time to
PHT Auditor Training & Certification PHT utilizes people time non-conformances occur that require corrective action.
within the quality department as the primary auditing resource. PHT’s Corrective and Preventive Action process includes follow-
Additionally, there is a team of trained internal auditors from up audits that are used to ensure the corrections remain in
across the organization. The use of trained internal auditors place and continue to be effective after the completion of the
from different backgrounds and disciplines ensures fresh corrective action plan. These corrective action plans and follow-up
perspectives. Like the processes they are auditing, specific audits are also readily available for reference before conducting
SOPs, training and experience are necessary to perform internal future audits within these process and business areas.
audits. Volunteers that come from management and staff
3. 3
PHT Vendor Audits In addition to internal Interview with Rod Thorell
auditing, PHT audits key suppliers of prod- Director, PHT Quality Management & Compliance
ucts and services. This gives us evidence
that key suppliers are following applicable
What is your role at PHT?
regulations, are maintaining effective
As the Director of Quality Management and Compliance, I have the responsibility,
internal policies and procedures and have
accountability, and authority to plan, direct, and administer PHT’s quality
adopted appropriate industry best practice
system. On any given day, that can mean duties as diverse as ensuring we are
for delivery of their products and services.
prepared for pandemic illness that could immobilize many of our staff, reviewing
Feedback from our audits allows our suppli-
regulatory compliance of StudyWorks™ software requirements or welcoming one
ers to strengthen their own quality systems,
of the many customer auditors that visit us each year.
creating stronger partners in business.
What are the contemporary issues of auditing?
Sponsor Audits of PHT As a supplier
ourselves, PHT is audited many times each Truthfulness! Coast IRB went from being a growing organization with revenues
year by current and prospective customers of $9.3m to shutting its doors in under a month, with the US Government
Accountability Office (GAO) probe and FDA warning letter scaring off existing
and partners. These audits and evalua-
and potential clients. In a recent undercover operation by the GAO, it has been
tions, which have ranged from one person
alleged that Coast IRB approved a fictitious protocol for research in humans,
on site for a day to eight people over three
claiming that the device was FDA-approved. These falsehoods led to calls for
days, are an excellent source of feedback
institutional review board (IRB) reform and a warning letter for Coast.
to strengthen our Quality Management
System. Observations from these audits are
treated the same way we would any internal “Auditing is like pulling a thread-even the best garments have a few loose
audit by being entered into a tracking system threads. A good auditor knows the difference between a random loose thread and
to ensure there is proper closure by the one that will unravel the entire sweater.”
responsible functional area. We encourage Rod Thorell, Director, PHT Quality Management & Compliance
any of our customers to take the time to visit
our facilities. These audits can be coordinated
through PHT’s local account executive. What do PHT customers commonly ask of our auditing processes
and procedures?
PHT strives to maintain a comprehensive People want to be sure that our audit program is structured and audits are
audit program. The internal audits include performed by trained personnel that have some independence from the area
a broad range of processes from our core they are auditing. Audits also need to have follow-up on the findings and
software development practices to Study should be analyzed for trends that can then be reported to senior management.
Support Center operations, even Senior There should be a ‘closed-loop’ system to ensure that audit observations are
Management. These business processes resolved. All of these are part of PHT’s internal audit program.
must conform to all of PHT’s policies,
procedures and ISO9001:2000 standards. How are FDA submissions affected by clinical data auditing processes
Furthermore, as a manufacturer and service and procedures?
provider to global clinical trials, PHT has At its best, auditing is about ensuring that sound processes and procedures
a commitment to ensure our processes exist and they were properly followed during the execution of an eClinical trial.
conform to regulatory requirements in over By proactively analyzing ourselves, the products and services we provide have
65 countries where we are engaged in clinical consistently proven to meet or exceed expectations of the regulatory inspectors
trials. Auditing allows us to ensure we are who review them.
compliant with an ever-changing global
regulatory landscape and deliver products Rod is Quality Management Systems professional with over twenty years of
and services that reliably meet customer experience in the Pharmaceutical industry. He joined the Quality department
requirements. at PHT in March 2007. Prior to joining PHT, Rod worked with several large
organizations, leading teams in the assessment, development and validation
of computerized systems for GxP applications.