Getting a study up and running is always a challenge.
It becomes even more difficult at peak holiday periods when many of those whom you rely on to help smooth the process are on vacation.
A critical part of any study start-up is a successful Ethics Submission. At Addyson Monitoring we understand the need for fast, but also accurate, submissions.
We also appreciate that a key component of a successful application is a Patient Information Sheet and Consent form that is tailored to suit the needs of your protocol but, at the same time, complies with both ICH GCP and the increasingly complex requirements of the UK National Research Ethics Committee system.
We provide a comprehensive service in writing NRES Ethic submissions to final draft and also producing protocol tailored information sheets and consent forms written to NRES version 3.2 May 2007.
When many projects are in the start up phase the difficulties to meet sponsor requirements and timelines can be greatly reduced by using our services.
- Reduce the pressure on full time staff
- Provide experienced staff dedicated to working in this field
- Expedite the compilation of your application
- Produce a submission acceptable to local regulatory authorities
- Facilitate a timely completion to achieve faster protocol approval
- Ensuring high standards of scientific and medical representation, to meet the requirements of the relevant competent authorities
We work closely with you at all times to determine your exact requirements and offer a fast turnaround to meet your timelines.
Our services include:
- High quality preparation of NRES NHS Research Ethics Committee application form. Version 5.3 to final draft.
- Bespoke protocol tailored information sheets and consent forms written to NRES version 3.2 May 2007 compliant with ICH GCP
- Study specific GP letters