Study Start Up

Study Start-up & Site Activation

• Oversee and manage all aspects of study start-up, including regulatory submissions,

ethics committee approvals, and site activation.

• Develop and implement start-up strategies to accelerate site initiation and first patient

enrollment.

• Ensure timely preparation, submission, and tracking of essential documents, including

clinical trial agreements, investigator site files, and informed consent forms.

• Collaborate with clinical operations, investigators, and site teams to address start-up

challenges and regulatory requirements.

• Coordinate with legal teams for contract negotiations and budget approvals with study

sites.