Clinical Trial Administration
Professional, Timely and Organised Clinical Trial Support
Illingworth Research Group (Illingworth) can administer all elements of a clinical trial in a professional, timely and organised manner. We pride ourselves on attention to detail and have a wealth of experience supporting small pharma, as well as managing the demands of larger pharma. All our CTAs (Clinical Trial Associates) work to ensure the compliance of our clients’ clinical trials with Illingworth Research or sponsor company SOPs, ICH-GCP and local regulatory requirements.
We have the capability to administer traditional Trial Master File (TMF) or utilise Montrium's Electronic TMF’s (eTMF) system. You can feel reassured whichever style of TMF best suits your trial Illingworth has the appropriate traditional and electronic protections to keep your data as secure as possible.
Why Illingworth's CTA's
Illingworth fully acknowledge and appreciate the vital role of a Clinical Trial Administrator (CTA) within your clinical trial. We view our CTA’s as a vital central-hub in the successful and smooth running of any clinical trial.
Our CTA’s have the support of experienced PM’s (Project Managers) and CRA’s (Clinical Research Associates) which ensure reliable and valid information. The unique element of Illingworth’s offering is the ability to provide a full CRO service alongside our Research Nursing and Medical Photography niche services.
The Role of an Illingworth CTA
The role of CTA covers many areas within a clinical trial and its wider organisation and maintenance. Some of these are explained below, which are true of CTA’s of Illingworth
- Coordination of study meetings, liaising with the sponsor and PM regularly.
- Coordinating ethics and regulatory applications – our CTA’s become specialists in the finest details of their studies managing submission deadlines, attachments and the relevant contacts at each stage of the approval process.
- Design and establishment of a Trial Master File (TMF) or Electronic TMF (eTMF) more recently. This includes the collection, maintenance and tracking of vital documents.
- Management of all email correspondence and appropriate mailboxes, usually requiring our CTA’s to monitor multiple inboxes.
- CTA’s assist in establishing Investigator Site Files (ISFs) as well as maintaining and updating these vital files.
- Tracking of documentation, developing and distributing documents. If a new protocol or change were to be required, this requires fresh signatures and redistribution to all sites.
- Finally, our CTA’s generally manage the coordination of documents for archiving.