CRO Services

Our Project Managers have extensive experience with managing global multicenter trials in various therapeutic areas. We work in a collaborative approach with sponsors to deliver study milestones within the required budget.

Project Management services include:

• Study planning and development of core documents (CMP, PMP, CP)

• Coordination of IRB submissions

• Site contract preparation and negotiation

• CRA supervision and mentoring

• Risk mitigation

• Study timelines delivery

Our Clinical Research Associates have in depth knowledge of industry regulations, and have been recognized to exceeds sponsors’ expectations. They work closely with the sites where they have built strong and trusted relationships across Canada.

Clinical monitoring services include:

• Site Qualification, Initiation, Interim Monitoring, Close-out visits

• Site support and guidance

• Essential documents review

• Ensuring study is conducted in compliance with protocol

Our scientific team have over 10 years of experience in the industry. Our scientific consulting and medical writing services include the development and review of:

• Phase I–IV protocols

• Manuscripts and papers

• Presentation posters and abstracts

Our scientific affairs team will prepare and coordinate regulatory submissions to Health Canada and to central IRB/ECs. Our services include filing and preparation of:

• CTAs/ITAs

• CTA-As and Notifications

• IRB/EC documents