Department At-A-Glance 1 Integrated Site Services Functional Role Integrated Site Services (ISS) includes global and country Start-Up and Regulatory units (RSU) and Integrated Patients & Site Services (IPSS). Our department’s main role is to recruit the right patients into the right trials at the right time. We use our expertise and knowledge to select and start the right countries and investigational sites as quickly as possible and support implementing the right tools to drive patient recruitment on a per project basis. Expertise IPSS Perform project feasibility Create the patient profile Create the site profile Country & site selection Create and monitor recruitment material and strategy RSU Perform submissions to Ethics and Regulatory bodies. Negotiate budget and contracts with the investigational sites.
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Department At-A-Glance · Integrated Site Services (ISS) includes global and country Start-Up and Regulatory units (RSU) and Integrated Patients & Site Services (IPSS). Our department’s
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Department At-A-Glance
1
Integrated Site Services
Functional Role
Integrated Site Services (ISS) includes global and country Start-Up and Regulatory units (RSU) and
Integrated Patients & Site Services (IPSS). Our department’s main role is to recruit the right patients into
the right trials at the right time. We use our expertise and knowledge to select and start the right
countries and investigational sites as quickly as possible and support implementing the right tools to
drive patient recruitment on a per project basis.
Expertise
IPSS
Perform project feasibility
Create the patient profile
Create the site profile
Country & site selection
Create and monitor recruitment material and strategy
RSU
Perform submissions to Ethics and Regulatory bodies.
Negotiate budget and contracts with the investigational sites.
Department At-A-Glance
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IPSS
RSU
Department At-A-Glance
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Clinical & Data Operations
Functional Role
Clinical & Data Operations is the largest individual business unit in the Clinical Development
organization, incorporating our Clinical Monitoring functions with Global Data Management. In bringing
together these units, Quintiles is well-positioned to sell and deliver an end-to-end clinical solution that
accelerates data flow and enhances quality.
Expertise
Clinical Operations
Protocol training of site staff
Perform monitoring of trial conduct to ensure patient safety and compliance with ICH-GCP
Data Operations
Creation of the (e)CRF and the database used in the project
Quality control on collected data from sites
Department At-A-Glance
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Clinical Operations
Data Operations
Department At-A-Glance
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Therapeutic Delivery Unit
Functional Role
The Therapeutic Delivery Unit (TDU) incorporates Clinical Project Management with our Medical &
Scientific Services group as well as the Therapeutic Delivery Solutions (TDS) group.
The unit is organised with a strong customer focus to align our delivery with customers’ needs for
therapeutic expertise in up-front planning and design, and excellence in execution. The unit consists of
multiple specialised therapeutic groups, such as Oncology, CVT, CNS, General Medicine etc.
Expertise
Clinical Project Management
Overall project delivery from proposal stage to study close out
Primary contact for our customers
Medical & Scientific Group
Medical input on protocol
Medical input on patient & site profile
Medical input on recruitment material
Training of monitors on the project
Therapeutic Delivery Solutions Group
Harmonization of internal Therapeutic Delivery groups
Department At-A-Glance
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Clinical Project Management
Medical & Scientific Group
Department At-A-Glance
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Quality Assurance
Functional Role
The global QA organisation is dedicated to supporting and facilitating the adherence to quality standards
and ethical behavior throughout Quintiles. QA will be relied upon to provide quality and regulatory
guidance to drive compliance in order to gain greater customer loyalty.
Expertise
Vendor audits, related to the Vendor Management Program
Creation of internal audit plan
Maintain QA status of investigators
Perform trial-related audits
Department At-A-Glance
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Global Customer Management
Functional Role
The mission of Global Customer Management (GCM) is understanding customer needs and selling
Quintiles’ solutions to meet those needs. This unit will continue its role in fostering strong customer
relationships and winning clinical business through our evidence-based sales approach.
Expertise
Receive request for proposal
Proposal creation & proposal defense
Negotiate (master) service agreements with customers and vendors
Department At-A-Glance
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Integrated Clinical Services
Functional Role
Integrated Clinical Services (ICS) includes Global Central Laboratories, Cardiac Safety, Biostatistics,
Medical Writing, Regulatory Affairs as well as Lifecycle Safety. ICS leads Quintiles’ high science strategy,
leveraging our biomarker, assay development, analysis, reporting and regulatory submission services to
help customers accelerate development. In this training, you will learn more about Biostatistics, Medical
Writing and Lifecycle Safety.
Expertise
Biostatistics
Protocol and (e)CRF Development
Statistical Analysis Plans and Statistical Programming
Analysis Interpretation and Reporting
Data Integration
Advisory Panel and DSMB Meetings
Cardiac Safety
• 12 Lead Digital ECG analysis and interpretation
• Thorough QT analysis as per E14 Guidelines
• Statistical and ECG Medical Expert Report Writing
• ECG Project and Data Management
• Internet Access to Quintiles ECG Web Portal
Medical Writing
Product development plans
Investigator brochures
Literature reviews
Trial protocols and amendments
DSMB report
Lifecycle Safety
Monitor safety and manage case reports
Improve the market value of your product with proactive planning and robust risk management
Department At-A-Glance
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Biostatistics
Medical Writing
Department At-A-Glance
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Lifecycle Safety
Department At-A-Glance
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Vendor (external)
Functional Role
We, as external vendors, are not part of the Quintiles organisation. We will collaborate with the
Quintiles team so that for the customer we are working as a united and integrated team. We can be
contracted for services that Quintiles does not offer.
Expertise
Central storage
Courier services
Central X-ray determination
ECG machines
Blood Pressure equipment
Investigator Meeting setup
Department At-A-Glance
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Support Services
Quintiles has several business units that are designated as support services. IT, Finance, Legal and the
Contact Centre are only four of these services.
IT
Apart from system maintenance, system integration and acquiring new systems to ensure greater
efficiency for the entire Quintiles organisation, we have a specialised unit within IT, who will provide
support to the project teams working on clinical trials.
Finance
The Finance department has many specialised groups to support the entire Quintiles organisation in
financial management in all its aspects. The Investigator Payments Administration (IPA) and Project
Finance Management (PFM) are two of these specialised groups to ensure timely payment and invoicing
on the clinical projects executed by Quintiles.
Legal
The Legal department is responsible for the creation of any company policy and is the primary point of
contact for any legal document that needs to be created like confidential disclosure agreements and
contracts throughout the organisation. During trials primary the Vendor Contracting Team and the
regional legal groups are involved.
Quintiles Contact Center (QCC)
The Contact Center is responsible for streamlining inbound and outbound communication to key
customers, including: patients, investigators, sponsors and study sites for the entire Quintiles’
organisation. In clinical studies we primarily support sites with logistical issues and technical or user
access issues.
Department At-A-Glance
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IT
Finance
Department At-A-Glance
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Legal
QCC
Department At-A-Glance
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Investigational Sites
Functional Role
The main parties involved on a country level would be the Site Staff, however we also communicate with
the country Central (and Local) Ethics Committee and a country Regulatory body. The Country Ethics and
Regulatory bodies will be responsible for reviewing and approving the protocol and related material and
subsequent amendments. The site staff will work with the Quintiles team in the execution of the