cdss

Clinical trial administration

Teamwork, Organisation and Attention to detail are our approach

At CDSS we can manage all elements of your clinical trial and are able to provide the following administrative services:

  • Coordination of meetings required for the purposes of the study
  • Coordination of ethics and regulatory applications
  • Design and establish the Trial Master File (TMF) framework
  • Collection, maintenance and tracking of Essential Documents within the TMF
  • Blinded and unblinded TMFs, maintained by separate teams with separate facilities
  • Coordination of correspondence; your own TMF email account(s)
  • Establishing Investigator Site Files (ISFs) for distribution to site
  • Maintaining and updating ISFs with all relevant documentation
  • Essential Document Checklists, for both TMF and ISFs, produced regularly for your review
  • Tracking of documentation development and distribution
  • Distribution of documents based on your requirements
  • Appropriate printing and fireproof storage facilities
  • Paper and/or electronic documentation produced for archiving
  • Coordination of archiving

All our CTAs work to ensure the compliance of our clients’ clinical trials with CDSS or Sponsor company SOPs, ICH GCP and EU directives.

 

 

 

 

The Art of Good Clinical Practice

Suite 5
Silk House
Park Green
Macclesfield
Cheshire
SK11 7QJ

UK +44 (0)1625
617447
US +1 508 293
4000
www.cdssltd.com

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