Department At-A-Glance

Transcription

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. 1

2 IPSS RSU 2

3 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 3

4 Clinical Operations Data Operations 4

5 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 5

6 Clinical Project Management Medical & Scientific Group 6

7 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 7

8 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 8

9 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 9

10 Biostatistics Medical Writing 10

11 Lifecycle Safety 11

12 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 12

13 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. 13

14 IT Finance 14

15 Legal QCC 15

16 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 16

17 Ethics/Regulatory Bodies Site Staff 17