Welsh Government

Commercial Clinical Operations Group (cCOG)

Commercial Clinical Operations Group (cCOG)

Purpose:

cCOG was formed: To represent commercial sponsors and industry partners of clinical trials and to ensure the UK remains competitive and a key player in the global clinical trials environment.
We exist to: Develop common understanding and support for streamlining clinical trial conduct in UK, promote knowledge sharing and identify best practices.
We work to: Support UK initiatives through delivering on our cCOG objectives.
In a way that: Promotes active patient and investigator participation in delivering quality research in the UK.

Vision:

To promote and facilitate commercial clinical research in the UK in partnership with NHS organisations to ensure highly competitive performance within the global arena by delivering to time and quality.

Operating Guidelines:

How we interact/communicate:
cCOG holds quarterly face to face meetings at the ABPI Offices, London. These may be supplemented by ad hoc team/sub‐team teleconferences should the need arise.

Members are required to attend a minimum of 3 meetings annually in order to retain membership and absences should be covered by an appropriate delegate from their organisation.

Meeting minutes, including presentations from guest speakers (with their permission), will be distributed to all Member Companies.

cCOG will make available the cCOG Charter, list of Member Companies, a summary of the current year’s Objectives, listing of future Meeting Dates and details of meeting topics and presenters (by permission) after each meeting through postings on a designated cCOG area linked from the NHS Research Scotland (NRS) and Health and Care Research Wales website(s).

Links to cCOG information and updates via the cCOG link/logo at

Members are encouraged to use the cCOG meeting minutes to provide cCOG updates to colleagues and when representing cCOG at other forums/meetings (see below).

Members represent cCOG through attendance at; R&D Forum, CREN, Road Map Group (RMG), ICR and Costing Group meetings.

It is noted that cCOG abide by the UK Competition Laws.

2017 Meeting Dates

Meeting dates for 2017 have been confirmed as:

  • Thursday 2 February
  • Friday 23 June
  • Friday 15 September
  • Thursday 9 November

Topics covered will be posted within 1 week following each meeting.

Member companies

cCOG member companies 2017 (pdf download)

Roles and Responsibilities

Rotating Chair
Will be assigned during each meeting to host the following meeting, in liaison with our ABPI host.

The Chair is responsible for compiling the agenda, liaising with members to present news and updates and/or guest speakers covering topics identified by the members.

The Chair will distribute the agenda in advance of the meeting and support the logistics with our ABPI host.

The Chair will collate speakers’ presentations in advance and chair the meeting.

Rotating Minute Taker
Assigned at each meeting to prepare for and take minutes during the meeting, using the cCOG meeting Minutes powerpoint template. Minutes will be distributed to members within 15 working days of the meeting.

Members
If unavailable to attend in person, members will ensure the ABPI host/rotating Chair are informed in advance, providing details of their delegate.

Members unable to attend at least 3 annual meetings should identify a replacement from their Company or their Company will be withdrawn from membership of cCOG.

All members are required to actively support the cCOG meeting and objectives.

Non‐sponsor members
Include representatives from ABPI, NIHR, NRS, Health and Care Research Wales and HRA representatives, who provide news and updates relevant to their organisation.

cCOG Objectives

Objectives:
cCOG members will agree annual objectives that will be supported each year by a sub‐team of members.

Members will take steps to deliver on the objectives and report back to members during cCOG Meetings. At the last meeting of the year a final review/close out of the objectives will be conducted.

New objectives, which may include those extended from the previous year, will be agreed at the first annual meeting.

cCOG members confirmed 2017 objectives:

  • Site Readiness and Activation (NEW)
  • Raising Patient and Public Awareness of Clinical Trials (ongoing)
  • Data Quality in Clinical Trials (ongoing)
  • Support optimal Clinical Trial Conduct in the UK through a rapid, smooth and clear HRA approval process both at study set up and amendments approvals (expanded from 2016)

Key Stakeholders

  • ABPI
  • CREN
  • RMG
  • R&D Forum
  • HRA
  • NIHR
  • NRS
  • NICRN
  • Health and Care Research Wales

2017 Meeting Overview

2017 Meeting Topics – to be updated within 1 week of cCOG meetings

23 June 2017 meeting notes (pdf download) 

2 February 2017 meeting notes (pdf download) 

If you would like to find out more about cCOG or wish to enquire about membership ‐ please feel free to contact: CommercialCOG@outlook.com 

A full listing of member Companies can be provided on request.