CRfocus: Table of Contents of July 2009 issue – 20(7)
Posted by Andrew Smith on July 6, 2009
CRfocus 20(07) – July 2009
Outsourcing
The Evolution of Outsourcing: Contract Management Coming of Age
Andy Parrett
The contract management role in clinical development outsourcing is still a relatively young profession. The nature of the role can vary significantly between pharmaceutical companies. Andy Parrett, Chair of the Pharmaceutical Contract Management Group (PCMG) suggests that the most exciting developments in the role are occurring in today’s small to mid-sized companies, and looks at how the processes surrounding outsourcing and its successful management are being developed.
Features
EudraCT Upgrades to Version 7
Andrew Smith
An information day was held by the EMEA at the end of April, bringing together representatives of national Competent Authorities (CAs), pharma companies, CROs and non-profit stakeholder groups. The purpose of the day was to communicate the features and development timelines of the next few versions of the EudraCT database of clinical trials in the European Economic Area (EEA), which went live in mid-June. Andrew reports, based on blog postings made on the day of the meeting.
CDISC European Interchange 2009: Conference Sketch
Adam Jacobs FICR CSci
CDISC (the Clinical Data Interchange Standards Consortium) is a relatively new player in the world of clinical research, having been founded in 1997, but it is rapidly gaining in importance, and is here to stay. To keep up with some of the latest developments in the CDISC world, Adam reports from the European CDISC Interchange, held in Budapest in April 2009.
Quality Assurance: Friend or Foe? A Survey
Jan Robinson MICR CSci
No-one questions the need for quality assurance of clinical trial activities but as someone at the receiving end have you ever been asked your opinion of the process? In your view, is audit a positive force for improvement? Are they the best means of advancing best practice or should we be taking a different approach? Jan invites you to take part in a short survey, to be reported in CRfocus and at the BARQA annual conference later this year.
Writing Protocols: Collaboration & Compromise or Conflict & Confusion? ICR/EMWA Joint Symposium
Alex Dedman & Andrew Smith
The challenges of developing clinical trial protocols were the topic of the second annual symposium jointly hosted by the European Medical Writers’ Association (EMWA) and The Institute of Clinical Research (ICR) on 24 February 2009. Around 60 delegates discussed the difficulties associated with developing protocols that both meet sponsors’ scientific and regulatory requirements, and facilitate the practical conduct of the study. Alex and Andrew report for CRfocus and The Write Stuff, the EMWA members’ journal.
People
Why You Should Care About the Innovative Medicines Initiative: An Interview with Jackie Hunter
Edward Blair MICR
The EU Innovative Medicines Initiative (IMI) was established in 2007 and issued its first call for proposals in 2008. Funding for the successful proposal has been allocated and the work kicks off in June this year. So, the IMI is for real and is beginning to deliver, but how well known is it and why will it change the pharmaceuticals industry in ways that will benefit ICR members? To get a first-hand insight into the aspirations of the IMI, CRfocus talked to Dr Jackie Hunter of GlaxoSmithKline, who has seen the IMI develop from a twinkle in the eye of EFPIA into the operating entity that it is now.
Conference
We are pleased to include two more session reports from the ICR Annual Conference, which space prevented us from including in last month’s issue.
International inspections
Fergus Sweeney & Gunnar Danielsson
Reporter: Judit Varkonyi-Sepp MICR CSci
Organ Transplantation: Past, Present & Future
Prof. James Neuberger & Mr Simon Bramhall
Reporter: Ali Zataar MICR CSci
Regular update
The Board of Directors: Who Are They & What Do They Do?: Message from the Chair
Janette Benaddi MICR Csci
The Institute of Clinical Research has a legal status of “a company limited by guarantee” and this means that it has to be managed by a Board of Directors. As members, you may wonder from time to time what the ICR Board of Directors do, who they are and how they add value to ICR members. Janette answers these questions, explains how the Board operates, and confesses her early (now-achieved) professional ambition to be a Board Director herself.
