Clinical Trial Unit (CRU) Development

The need for an experienced Investigator and Clinical Trial Staff

An experienced Investigator and clinical trial site staff are crucial to the success of any clinical trial study. Although there are many experienced clinical trial investigator and clinical trial site, there are also first timer, and less experienced one. Some might already have previous clinical trial experience, but might be lacking of Phase 1 first in human trial or never become a lead site which comes with additional responsibilities.

Finding the perfect Investigator and site that ticked all the boxes can often be challenging as sponsor now need to compete with other sponsors. Quite often sponsors might find the right Investigator and site but they just needed a bit of support because of capacity or experience issue.

Obatica’s Clinical Trial Unit Experience

With experiences at large hospital based clinical trial sites, Obatica is able to evaluate, train, develop, and mentor a newly established or less experience CRU to enable it to participate and excel in a study. From developing tested SOPs, one to one mentoring of Investigator or clinical trial coordinators. We are able to support in the review of budget, ethics submission, regulatory submissions, and many other clinical trial support and management activities.

Obatica has many experience with end to end clinical trial site related activities such as site selection, protocol review, site initiation visit, site audit, management of adverse event, regulatory and ethics reporting, and study close out. Obatica has also supported in the training and guidance of less experience Investigators wanting to do complex clinical trial such as first in human phase 1 studies.

Clinical Trial Unit (CRU) Assessment and Audit

Obatica has developed a comprehensive clinical trial unit (CRU) assessment and audit framework that can map the strengths and are of improvement on a particular unit. The assessment can also suggest a suitable program to improve the unit to the intended level that management desires. The process will start with a friendly visit by our team to the CRU and then subsequent meetings can be planned. The entire process usually takes around 3 weeks.

Contact us for a confidential discussion.