Services
Study Support | Study Rescue | Customized Support
Clinical studies have a lot of moving pieces! From start to finish, there are many components that are needed to make your trial a success.
Too often the resources, staffing, and/or expertise are lacking and your study needs help!
We assist Sponsors and CROs with anything and everything that will lead their study to success.
Our experience is key; our drive comes from within; our passion is unmatched. We love what we do!
Study Support
Start Up | Maintenance | Close Out
Start Up
Whether you need help with feasibility or getting your first site activated, our team will work with yours to begin all start-up activities.
Your Study Startup Consultant can:
• Create project plans and site binders
• Design PSV, SIV and IMV guidances, slide decks, and annotated trip reports for CRA use
• Assist with building study timelines and providing vendor and budget oversight
• Conduct site and country feasibility assessments to identify potential sites for participation
• Plan and conduct virtual or in person Investigator Meetings
• Ensure FPFV targets are met or create timely mitigation strategies to ensure success
Let’s Discuss!
Maintenance
Do you need monitoring and ongoing oversight on an already activated study? Our team will create an effective and seamless transition plan.
Your Study Maintenance Consultant can help with:
• Recruitment and retention
• Risk management
• Vendor management
• Data management
• eTMF maintenance
• Study guidance
• Ensuring the study remains on track
Let’s Discuss!
Close Out
The study may be complete, but there are still many required tasks in the finalization process. We provide assistance with study closure activities.
Your Study Closeout Consultant can help with:
• Database locks
• Cleaning data
• Return of drugs and supplies
Let’s Discuss!
Study Rescue
Did your study fall off track?
We can help save your study! Your goal is our goal: to deliver high-quality results, on time, and within budget.
Your Study Rescue Consultant will:
• Determine where the study went wrong
• Figure out if and how the study can be corrected
• Formulate a clear action plan to move forward with the remainder of the study
Let’s Discuss!
Customized Support
Not seeing exactly what your study needs?
We are happy to customize our support based on your specific situation!
Your individualized support may include:
• Planning
• Task management (short and long term)
• Review of study procedures, plans, and/or protocol design