Company Information

Company Name:

Contact Person:

Title:

Email:

Phone Number:

Location (City/Country):

Study/Project Overview

Therapeutic Area:

Study Phase:

Study Title:

Brief Study Summary:

Approximate Study Start Date:

Approximate Study Closeout Date:

Services Required (Select all that apply):

1. Study Start-up*

Study Start-Up Coordination
Vendor Selection & Oversight
Site Selection & Activation
Regulatory Submission Support
Project Management
Site Monitoring Strategy
CRO Oversight

2. Study Maintenance*

Study oversight for all sites and countries
Manage reports from CRAs and operational teams
Ongoing vendor management
CRO Oversight
Conduct Study Team Meetings
Engagement with KOLs, Steering Committee, DMCs
Manage protocol deviations and issues
Resolve Daily Operational Issues
Provide weekly summary reports to management

3. Study Closeout*

TMF reconciliation
Investigational Product reconciliation
Patient data reports reconciliation
Site/vendor contracts and budgets reconciliation
Site closeout
Submission of regulatory reports
Support for CSR development

4. Full Support

Complete End to End Management

Study Design Details:

Number of Countries:

Number of Sites:

Estimated Randomizations:

Duration of Study:

CRO Outsourced Study:

Number of Vendors:

Target Timeline or Milestones:

Protocol Finalization:

First Site Activated:

First Patient Screened:

First Patient Randomized:

Last Patient Screened:

Last Patient Randomized:

Last Patient Last Treatment:

Database Lock for Primary Endpoint:

Additional Comments or Unique Needs:

Intended Date of Engagement / Hire:

Contract Term:

Scope: