Study start up is one of the most critical and challenging phases of any clinical program. A poorly planned start puts your program behind schedule before a single patient has been enrolled. This phase is frequently the most labor intensive due to the high level of activity in a compressed time period. Short-term supplemental resource support during this period may be the solution to a successful start.

Kaizen understands the importance of this phase to your programs success and can offer the level of resources, both in experience, numbers and duration of assignment, you need to move your program through start up and into operational phase.

Our start up services and staff can assist in some or all of the following activities:

• Design, implement and analyze a study specific feasibility assessment to assist in site selection, distribution and predictive enrollment rates
• Work with identified sites to: Secure required IRB approvals as well as negotiate budgets and secure contracts with investigators, institutions and third party vendors
• Our training group can provide project specific training for the investigative site staff and monitoring staff
• Kaizen can also execute planning and conduct of the Kick off meeting or work in conjunction with your meeting planner as needed

As with all our services offerings at Kaizen, you may choose this as a stand-alone service. Please contact us to discuss your project start up needs with our experts.

• Feasibility assessments
• Identification and recruitment of qualified investigative sites
• Site/facility qualification visit
• Review and negotiation of investigator budgets
• Review investigator contracts
• Collection, review and tracking of regulatory documents
• Initiation visit