Addyson

In order to process a successful feasibility assessment the following criteria are important components.

• Investigator and clinical trial manager interest
• Number of eligible patients expected to recruit
• Concurrent trial workload, particularly at recruitment stage
• Previous experience in similar clinical studies
• Recruitment & retention in prior clinical trials
• Site personnel study experience and training
• Trial-required facilities such as laboratories and pharmacies
• Trial-specific equipment e.g. measuring and imaging apparatus
• Quality assurance processes
• Additional sponsor requirements

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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

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At each monitoring visit, according to project scope, CRA's review:

• Protocol compliance
• Case Report Form (CRF) accuracy and completeness
• Serious Adverse Event (SAE) reporting to the required bodies
• Tracking of mandatory reporting to Ethics (IRB) & Regulatory authorities
• Enrolment & suitability of participants
• Trial progress & review of strategy
• Continued acceptability of investigator and facilities
• Filing and maintenance of source documents
• Investigational Product inventory and accountability records
• Compliance of investigator's document file
• Collection of data for interim analysis

Cel lacus. Prestibulum vel lacus vitae tortor consectetuer sapien sis, lacinia sed, lacinia et, augue. Vivamus ultrices lacinia urna. Proin varius sollicitudin nunc. Vivamus condimentum, dui nec imperdiet porta, odio risus molestie nisl, nec laoreet purus sapien a massa.