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.

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.

4. 4
Why Auditing is Critical to Sponsors
By Laura Araujo storage of data over time. The Quality System must identify
Sr. Consultant, Quality Management critical processes and define them up front. An Audit can
Halloran Consulting Group help identify if there are issues related to process or require-
August, 2009
ments, and enable the company to take corrective action as
soon as possible.
As an independent Auditor, Laura Have you ever worked with the FDA on recreating a study?
Araujo interfaces with a wide range
No, but I have hosted many FDA inspections where the focus
of biopharmaceutical organizations,
has been completely on the audit trails: walking through them,
guiding executives through trial
explaining them, and ultimately showing control of studies
preparations and FDA inspections. Following are excerpts taken
over time. Many people are mistaken in believing that technology
from a recent interview with Laura.
companies like PHT provide software or devices as their
How do you explain the auditing deliverable. The software and devices
function to your clients? are merely tools to assist in gathering
“One of the most impressive things from a
The best way to think about audit- the data for a trial. The real deliverable for
sponsor perspective of PHT is the Archive,
ing is an activity of assurance and PHT is actually the Archive—including
which enables every sponsor to completely all specifications, data, deliverables,
continuous improvement—assuring
you are following your processes, recreate a trial with data and context, without and change control over the course
assuring you are collecting the any time limit. The Archive doesn’t require any of the trial. PHT’s responsibilities do
correct deliverables, assuring you additional funding (such as server support). not end at successful distribution of
can recreate a study—and then The PHT Archive is the best example of devices. It ends when the Archive
evaluating results and output to is complete.
complete trial validation and recreation I’ve
continually improve over time. Laura joined Halloran Consulting Group
ever seen in my 25 years of process auditing.”
What is your fundamental recom- in 2008, and assists biopharmaceutical
mendation to biopharmaceutical Laura Araujo companies with their quality manage-
companies preparing for a clinical Certified Auditor and Corporate Trainer ment system implementation, software
trial? development, validation and training.
The most important thing a company Laura brings over 25 years experience
can do in preparation for running a clinical trial is to have clear in quality assurance, technology management and software
and well defined processes up front. If you do, even the most development with a focus on the biotechnology and pharma-
complex study is simple to audit. If you don’t have your processes ceutical industries. Prior to Halloran Consulting, Laura was Vice
well defined, including deliverables and responsibilities, even the President of Quality at Perceptive Informatics, a subsidiary of
simplest Audit will be difficult, and the study may be unable to PAREXEL International, where she managed quality assurance
be recreated. and computer systems validation as well as corporate quality
systems including validation, supplier management, internal
Can an audit ‘fix’ data quality? audit program, regulatory, patient confidentiality and training.
No, you cannot “audit in” data quality. The key to data quality Prior Perceptive, Laura was the Vice President of Quality,
is ensuring that you have sufficiently defined and addressed Information Technology, Customer Support and Hosting
all issues up front related to collection, security, integrity, and Services at Clinsoft.
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