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

Department At-A-Glance

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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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IPSS

RSU


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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


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Clinical Operations

Data Operations


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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


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Clinical Project Management

Medical & Scientific Group


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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


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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


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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


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Biostatistics

Medical Writing


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Lifecycle Safety


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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


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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.


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IT

Finance


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Legal

QCC


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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

project.

Expertise

Ethics/Regulatory bodies

Review of project regarding

ICH-GCP requirements

Regional and country legislation

Medical validity

Scientific validity

Patient safety

Site Staff

Primary contact for patients

Recruiting patients

Maintaining Source Documents

Completing (e)CRFs


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Ethics/Regulatory Bodies

Site Staff