Site Monitoring

Liliya BiletskaWe are pleased and proud to have a team of fully trained and experienced Clinical Research Professionals who can monitor your study to the highest standards and ensure the fast flow of clean top-quality data.

Training is given and maintained, with appropriate refreshers and updates, in ICH-GCP guidelines, local regulations, FDA Regulations and the EU Clinical Trial Directive as well as the latest EU Regulation (No 536/2014).

Many of our team have come from medical backgrounds, enabling them to work with clinical sites on complex trials. We always employ CRAs who are excellent communicators, firm but fair with interpersonal, communication and management skills necessary to work closely and in harmony with clinical site staff.

Whether it be traditional paper CRFs or electronic data capture (EDC) our monitors are experienced in working with various platforms.  We have experience monitoring all trial Phases: 1 – IV.

At Clinical Accelerator, we all keep abreast of industry and regulatory recommendations and trends and recognise the advantages of a risk-based approach to monitoring, which we apply where appropriate.  Targeting monitoring activities where they are going to deliver the greatest benefit to the study by looking at the risks to the study represented by each site and by the type of data that are being collected helps to decide where monitoring effort would be used to greatest effect – limiting both time and cost.  In conjunction with our data management department who offer ‘simple’ and more sophisticated web-based e-solutions along with traditional paper management techniques, remote-monitoring can further increase efficiency of risk-based monitoring techniques as required.

Clinical Accelerator is known for its highly successful recruitment strategies (see Patient Enrolment) and our monitors play a key role in this by maintaining the focus and motivation of each site and encouraging both recruitment and retention of trial subjects.