Our services

Helping sponsors save time and resources.

Project Management and Monitoring

We offer Clinical Project Management and Clinical Monitoring services to commercial and non-commercial clients. We can also offer Clinical Trial Programme Management

RISK BASED APPROACHES

We are experienced in Risk assessment and applying Risk Based approaches to all aspects of clinical trials e.g. using risk-based and adaptive Monitoring, Risk Registers and Adaptive Techniques.

SPONSOR AND VENDOR OVERSIGHT

We can advise Sponsors on their Sponsor and Vendor Oversight responsibilities- a key focus area in the new ICH GCP R3 Guideline.

TRIAL MASTER FILES & ARCHIVING

We can assist with set up of Electronic Trial Master Files and Electronic Investigator Study Files, facilitating the clinical trial process and optimising resources for research teams and monitors.

We can advise on appropriate archiving solutions that provide restricted and secure storage that will remain viable throughout the extended retention periods required by regulatory authorities.

INNOVATIVE APPROACHES

We can work with clients wishing to provide innovative approaches to data collection and trial management e.g. E-Patient Reported Outcome (E-PRO) measure collection, Decentralised Trials, e-consent etc.

SOPS AND TRAINING

We can assist with set up of Clinical Operations Departments for new companies e.g. :-

• Standard Operating Procedure writing.
• Cost-effective training in all aspects of clinical trials for Investigators and Clinical Trial Personnel in Project Management, Monitoring, ICH GCP and Clinical Trial Regulations.
• Our ICH GCP R3 Training course has been recently launched - you can find more details on this below:-

ICH GCP R3 ONLINE TRAINING COURSE

Our new Trancelerate-approved ICH GCP R3 training course is available here.

Please get in touch here - hilary@carnegieclinicalresearch.co.uk if you would like further information on accessing this course. Large group discounts and personalised training options available.