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Risk, Complexity and Compliance management.


PCMG Annual Conference 10-12 June 2015 | Warsaw, Poland | Risk, Complexity & Compliance

The Bank Job: A Project Management nightmare or unique opportunity to fully harness provider expertise early and effectively?

The London underground system first opened in 1863 to become one of the busiest, most complex public transport systems in the world with 270 functioning stations. The Bank Underground Station, the network’s deepest at 41.4m. first opened in 1900, it carries the Central, Northern, Waterloo & City lines and the Docklands Light Railway, also linking to the adjacent Monument Station. All this is underneath one of the busiest intersections of roads and historic buildings of the City of London.
And now…50% growth in use over ten years to over 337,000 passenger journeys a day has created the need for a major reconfiguration to enable safe and efficient passenger flow. This project will include a new tunnel, entrance, moving walkways, more lifts and escalators installing to meet modern standards while minimizing disruption to passengers!
As well as being very complex, the pressure to complete the project on time, to exacting specifications, safely and within budget has a great parallel with clinical trials. Multiple vendors, competitive costings, constrained timelines and….. an unforgiving sponsor, the taxpayer.
This required an alternative approach in project management and outsourcing to improve relationships with the contractor, facilitating early involvement while developing major design and build contracts. The goal was to drive innovation to enable reduction of costs and risks while still maintaining a competitive and commercially viable arrangement with the providers.
Our presenter Simon Addyman MSc (dist), MAPM (CPM) is an experienced program and project manager whose was the winner of the Project Professional of the year 2013 (award sponsored by the Association for Project Management). Simon will discuss the opportunities identified during his leadership of this complex project and how our outsourcing practices might learn from his experience.
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The Effect of Principle/Agent on Project Success

Event Type: Webinar

Starting: 02/06/2015

Organised by: PCMG

PCMG Annual Conference 2015 - Managing Risk, Complexity and Compliance

Event Type: Conference

Starting: 10/06/2015

Organised by: PCMG

PCMG Outsourcing Models Workshop

Event Type: Workshop

Starting: 08/10/2015

Organised by: PCMG

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Latest Newsletter:

Announcing PCMG’s Annual Conference to be held at the Westin Hotel, Warsaw, Poland
10th – 12th June 2015

Risk: Threat or Opportunity?
Managing Risk, Compliance and Complexity

Clinical Trial Management continues to face challenges in achieving the timelines and quality standards needed to meet ever-increasing regulatory and commercial requirements. To help members prepare and overcome these challenges, PCMG’s 2015 Conference will focus on three topics; Risk, Complexity, and Compliance in clinical outsourcing.

The regular high-quality presentations, animated Oxford debate and thought-leader opinions will be supported see greater audience interaction and a new ‘PCMG Room 101’ feature to highlight targets for change in practice.

The 2015 Conference theme of Risk, Complexity and Compliance has been developed into programme that will provide the traditional PCMG value for delegates and is now available. We have:

  • Investigated the reality of Risk Based Monitoring
  • Examined the value of Key Personnel in successful outsourcing
  • Looked down into the innovations of the London Tube reformation
  • Prepared to debate the role of Procurement vs. CRO Relationships
  • Challenged how complexity in clinical development is managed
  • Shone a light on vital aspects of compliance in clinical studies and outsourcing implications

Over the coming weeks you will see examples of these topics as well as a new feature, PCMG's Room 101, that will name and shame outsourcing practices that are in urgent need of permanent retirement and replacement with best practice.

Not signed up yet? There are limited rooms available at PCMG's preferential rate in the conference hotel. Go to the Conference Page to download the programme and for a link to the conference hotel website!

New PCMG Email Address

Please note that the new email address for PCMG is admin@pcmg.org.uk and this will officially take effect from 1st September 2014.

Please can you update your records accordingly. The old email address will remain active for the foreseeable future.

PCMG is reviewing existing templates and developing new ones for guidance in clinical outsourcing management

In 2013, a small team of PCMG members reviewed and updated the original PCMG 'Cost Grid' Template and presented the attached overview of the process.
This template is intended as a starting point for members who don't have a standard grid to follow and then develop into a suitable process to meet their specific local needs. For those who already have a grid and are entering an RFP process, it at least provides a cross-check of content and process.

So, all of you who are about to enter......enjoy, test and, most importantly, let us know what you'd improve!

Finally, our thanks go to the fine people who donated time and energy into this review:

  • Bodil Vistisen, Novo Nordisk (Sponsor)
  • Rich Baptista, PAREXEL (CRO)
  • Tarminder Bains, Gilead (Sponsor)
  • Victoria Winters, Leader Partners (Consultant)
  • Chris Kenward, Eisai (Sponsor)
  • Stuart McGuire, Chiltern (CRO)

For access to the documents Click Here



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