Bulletins & Newsletters:
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 email@example.com 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