Due to the implementation of the EU Clinical Trials Directive 2001/20/EC the need for a valid application to NHS Research Ethics Committees (REC) is of even greater importance. The single most important change to this quality-driven mechanism for assuring the ethics of the conduct of your clinical trial is the introduction of strict timelines for review, and decision. A maximum of 60 days review-period for the majority of trials (there are a few exceptions) stamps a dramatic administrative burden on everyone involved in the process. Our experience in this field is second to none. The Phlexglobal CTA Team has been at the forefront of the changes to REC submissions since their conception and is expertly positioned to offer guidance and assistance in this critical sector. We can act as consultants to your own submission or, better still, we can take the whole project off your hands and be responsible for the submission, and approval, whatever the scale of the clinical trial.

Handpicked CTAs who specialise in REC work, working within the Sponsor Company or from our office, will set up and maintain an efficient focal point for the co-ordination and processing of submissions. Enjoying the role of REC Co-ordinators, either full time, or part time, our CTAs will co-ordinate and track submissions, eliminate common errors that cause delay, maintain vital proactive communication, collate and distribute all relevant documentation and notify all interested parties of decisions in an agreed timely manner. Our experienced CTAs are able to predict when issues regarding deadline goals might arise and an agreed warning system is always set in place between the CTA and the Sponsor Company contact.

All CTA (REC-Co-ordinators) will have appropriate, proven, training in the field of REC Submission. Any part of the service can be utilised, in part or in full, at very competitive rates, for example,

• Complete all forms and co-ordinate the submission throughout,
• Assist in education and training of first time applications,
• Focus on the timelines and proactively initiate prompts and reminders,
• Assure quality with regard to version control, sequencing, and tracking changes,
• Ensure consistency checks for amendments and across multiple submissions,
• Finalise essential documentation for the TMF.

This is a tried and tested service that has proven to be cost effective and efficient

Contact Karen Roy at Phlexglobal today (01494 720420, kroy@phlexglobal.com) for more information.