Phlexglobal Specialist Support CRO

Phlexglobal Specialist Contract Research Organisation

Supporting the Pharmaceutical, Biotech,

CRO and non-commercial industries in the

management of global clinical trials

Phlexglobal

• Founded – 1997

• Specialist Support CRO with a primary business focus on clinical

trial documentation, resource provision and system support

• Instrumental in pioneering the role of Clinical Trial Administrator

• Extensive staff training programme • Extensive staff training programme

• 13 years of Trial Master File document management experience

• 8 years experience working with electronic Trial Master Files

• Flexible support models

• Successful MHRA Inspection July 2009

Five Support Services, One Solution

Resourcing

• Providing clinical research professionals at Client premises

• Key focus on CTAs, CRAs, Project Managers and Managers and Document Administrators

• Permanent, Contract or Temporary

Task Force

• Short-term interim support

• Client or Phlexglobal based

• Client or Phlexglobal Project ManagementProject Management

Clinical Support Services

• Remote CTA and Administrative Services

• Client technical system connection

• Client SOP governed• Client SOP governed

• Client and Phlexglobal based

• Monitoring and Site management Services

Training

• Focus on document recognition and management

• Internal and external training

• Industry knowledge and business skills and business skills

• Standard and bespoke courses

• eTMF workshop

• ICR collaboration

• e-Learning

eTMF and Document Solutions

Supporting Trial Master

Files (TMFs) globally

Records Management Capabilities

1. TMF and Records Management Consultancy

� Business process enhancement

2. Records Management Training

3. Provision of Resource

4. Storage of Paper TMF4. Storage of Paper TMF

5. TMF Quality Control

6. PhlexEscan

7. Archiving

8. Client eTMF Support

9. PhlexEview

Records Management Capabilities

1. TMF and Records Management Consultancy

2. Records Management Training

� Knowledge curriculum

� Underpins Phlexglobal service

3. Provision of Resource3. Provision of Resource

4. Storage of Paper TMF

5. TMF Quality Control

6. PhlexEscan

7. Archiving

8. Client eTMF Support

9. PhlexEview

Records Management Capabilities

1. TMF and Records Management Consultancy

2. Records Management Training

3. Provision of Resource

� Phlexglobal based, through remote connection

� Client based� Client based

4. Storage of Paper TMF

5. TMF Quality Control

6. PhlexEscan

7. Archiving

8. Client eTMF Support

9. PhlexEview

Records Management Capabilities

1. TMF and Records Management Consultancy

2. Records Management Training

3. Provision of Resource

4. Storage of Paper TMF

� Secure room, with tracked access

� Roller racking system � Roller racking system

� Gas suppressant fire system

� 3rd party testing and validation

5. TMF Quality Control

6. PhlexEscan

7. Archiving

8. Client eTMF Support

9. PhlexEview

Records Management Capabilities

1. TMF and Records Management Consultancy

2. Records Management Training

3. Provision of Resource

4. Storage of Paper TMF

5. TMF Quality Control

� Experienced staff� Experienced staff

� Independent check

� Multi-client experience

� Certification

6. PhlexEscan

7. Archiving

8. Client eTMF Support

9. PhlexEview

Records Management Capabilities

1. TMF and Records Management Consultancy

2. Records Management Training

3. Provision of Resource

4. Storage of Paper TMF

5. TMF Quality Control

6. PhlexEscan6. PhlexEscan

� Regulatory compliant scanning with book-marking and hyper-

linking

� 300dpi, bitonal, grey-scale or full colour, duplex, WORM data

captured

� PDF/A

7. Archiving

8. Client eTMF Support

9. PhlexEview

Records Management Capabilities

1. TMF and Records Management Consultancy

2. Records Management Training

3. Provision of Resource

4. Storage of Paper TMF

5. TMF Quality Control

6. PhlexEscan

7. Archiving

� Sponsor documentation archive preparation and storage

� Independent Investigator archiving service ‘Firewall’

� SOP writing and training

� Nominated archivist

8. Client eTMF Support

9. PhlexEview

Records Management Capabilities

1. TMF and Records Management Consultancy

2. Records Management Training

3. Provision of Resource

4. Storage of Paper TMF

5. TMF Quality Control5. TMF Quality Control

6. PhlexEscan

7. Archiving

8. Client eTMF Support

– Remote access to Client systems (e.g. SharePoint / Documentum)

– Paper processing at Phlexglobal offices

9. PhlexEview

Records Management Capabilities

1. TMF and Records Management Consultancy

2. Records Management Training

3. Provision of Resource

4. Storage of Paper TMF

5. TMF Quality Control5. TMF Quality Control

6. PhlexEscan

7. Archiving

8. Client eTMF Support

9. PhlexEview

– Bespoke eTMF solution

– External to the Client IT environment

– Validated to include DIA TMF Reference Model

Contact Karen Redding at kredding@phlexglobal.com or on

+44 1494 720420 for more information

Phlexglobal

The Complete Study Support Solution