The work performed by a Clinical Trial Administrator (CTA) is pivotal to the efficient running of a clinical study. As such it has historically been considered to be an in-house position. In today's office environment however, advances in IT support have enabled related administrative activities, whether on a local or global level, to be performed via remote IT links or over the telephone.

With the increased complexity of study tracking tools, databases and the growing need for electronic data collection, the functionalities and scope of IT systems are also evolving. Enhanced IT systems and processes often require more focused, specialist support and expertise to ensure accuracy, integrity and quality of collected data.

Phlexglobal have a team of experienced Clinical Trial Administrators covering general administrative activities and experts providing specialist support. These services can be provided by experienced professionals based either at the Phlexglobal office in Buckinghamshire (securely connected to the client's server) or based at the client's office, benefiting from central project management and line management support from Phlexglobal.  Clients can achieve flexible and efficient resourcing solutions and gain ongoing and long term support through this type of Functional Service Provider or FTE model.

The following list gives examples of activities which can be performed by the team:

Study documentation (link to eTMF and doc solutions)

• Sponsor Central File (core Essential Documents):
  - Management of hard copy Sponsor Central Files through their life-cycle
  - Set up of filing structure for paper and electronic study records

• Regulatory Documents:
  - Collection and QC of regulatory documentation
  - Submission to regulatory authorities for approval of IP shipment
  - Tracking document collection using Excel and specific databases
  - Reconciliation of systems and documents at study closure
  - Liaise with external vendors to finalise docs in preparation for FDA submissions

• CSR Appendices:
  - Compilation of appendices for inclusion in the Clinical Study Report

• Archiving
  - Monitoring of key study milestones and guiding study team through the ongoing process of preparation for archiving
  - At study close, collection of hard copy and electronic Essential Documentation and its preparation for submission to archive

Investigational Product and study supplies tracking

• Approval of IP shipment requests
• Maintenance of sufficient IP stock levels at the site and local country depots
• Preparation and distribution of non-drug supplies (i.e. study materials, emergency cards, pre-screening packs)
• IVRS liaison
• Lab sample tracking and reconciliation
• Decommissioning of various systems after study close-out
• Co-ordination of printing and distribution of paper copy CRFs

Clinical Trial Management systems and Tracking Tools

• Set up and maintenance of study file sharing systems and databases and management of posted documents in accordance to the applicable retention policies
• Set up and maintenance of Study Team Contact Lists through the life of the study
• Tracking and maintenance of study budgets and investigator payments
• Set up and maintenance of Clinical Trial Management Systems
• Management of user lists
• Generation of reports and exporting of data from Clinical Trial Management Systems
• Supporting recruitment planning and performance analysis

eCRF:

• Responsibility over approving eCRF access to the study team and site staff
• Ensuring correct access level has been granted and relevant training completed
• Supporting resolution of data management queries close to the DBF milestone
• Generation of data quality reports and query resolution metrics

Specialist activities

• Administrative support for eCRF access and training for study team and site staff
• Document proof-reading
• General system tracking and maintenance (finance, medical, marketing)
• Acting as experts/lead users/administrators on a variety of IT systems