RAPID STUDY START-UP
Based on our experience in crisis-response settings, we’ve developed a key set of activities and resources that enable us to meet compressed trial start-up timelines.
We follow a core set of steps to achieve rapid study start-up:
Leverage our proven toolbox of resources for rapid study start-up.
Designed to support the entire study timeline, our resources have been developed and tested over our long history of conducting studies in challenging settings. These resources have been developed to aid with study start-up and conduct for sites with limited research experience.
Templates and examples of contracts that span the typical study needs, including procuring supplies, consulting, laboratory services and more
Templates and examples of SOPs for studies of all types, including clinical trials, epidemiological studies and behavioral studies
Comprehensive lists of activities that should be completed during the study planning, start-up and conduct phases
Templates and examples for monitoring, data management, statistical analysis, lab conduct and safety
Resources that assist with registering an in-country NGO, establishing a bank account, initiating payroll processes, procuring supplies and promptly paying vendors
Contracts
Standard operating procedures (SOPs)
Checklists of key activities
Plans
Lists of organizational resources
contracts
Templates and examples of contracts that span the typical study needs, including procuring supplies, consulting, laboratory services and more
Rapid Project Launch (RPL)
We’ve developed key resources, an expanded project team and a process to review all aspects of starting a new study.
Resources
- Checklists of key activities to be completed
- Lists of organizational resources to assist with registering an in-country NGO, establishing a bank account, initiating payroll processes, procuring supplies and promptly paying vendors
Project team
- Clinical project managers
- Contracts and grants specialists
- Finance managers
- Human resources representatives
- Procurement personnel
- Senior management
Daily meeting
- Prioritize tasks
- Anticipate potential problems
- Take action to overcome any barriers
Meeting compressed trial start-up schedules
In the Sierra Leone trial to introduce a vaccine against Ebola (STRIVE), the study team succeeded in reaching first patient, first visit (FP/FV) six weeks after arrival in Sierra Leone.
Deployed first members of the project team to Sierra Leone 10 days after the letter of authorization; hired and trained local project management and data entry staff
Deployed the first CRAs to Sierra Leone
Hired 28 local staff
Provided GCP and study-specific training to more than 300 newly hired study staff
Team established cold chain and began supporting trial vaccination sites as they opened
Opened first vaccination site in the Western Rural district and enrolled the trial’s first patient, just over six weeks after the start-up team arrived in Sierra Leone
Opened three more vaccination sites: two in May and one in June
Learn more about our specific experience through our case studies:
Case Study
Phase II Trial of a Chikungunya Vaccine in the Caribbean
The study team maintained a 91% retention rate in a study of a Chikungunya virus (CHIKV) vaccine, despite study disruptions due to natural disasters, including Hurricane Maria, and political unrest near the sites in five Caribbean countries in a CHIKV endemic region.
Case Study
Rapid Study Start-Up for the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)
Within a challenging, resource-limited setting, the project team succeeded in reaching FP/FV six weeks after arrival in Sierra Leone and 99.998% accuracy of the planned-to-execute budget.
