Services Provided 

• Trial operationalization - Prepare, execute, and manage trial operations from beginning to end and everything in between to get your study ready to enroll participants. Including but not limited to site activation, screening and recruitment, budget and contract, regulatory, and more. 

• Protocol review - Assess protocols for compliance with regulatory/GCP requirements. 

• Budgets and contracts - Swiftly and efficiently negotiate competitive study budgets and process contracts with study sponsors.

• Source document creation - Create well-designed source documents including electronic case report forms (eCRFs) to capture the data needed for the study.

• Recruitment and retention - Assist with identifying approaches to participant recruitment, retention & engagement. Develop recruitment plans, recruitment materials, and retention materials.

• Regulatory Documents - Prepare, submit, and manage regulatory paperwork including protocol signature pages, 1572s, and financial disclosure forms. 

• Consent Documents - Prepare and develop study informed consent documents including assent forms. 

• IRB submissions - Prepare, submit, and manage IRB submissions including initial and maintenance submissions such as changes, continuing reviews, reportable events, and closure. 

• Study Coordination - Manage clinical trials from beginning to end including identify, screen, and recruit participants, obtain informed consent, administer participant questionnaires, collect and prepare study documentation, ensure protocols and procedures are followed, and more.  Coordinate communication between researchers, collaborators,  sponsors, and participants.

• Monitoring - Provide study monitoring to ensure the rights of participants are protected,  study data is accurate and complete, and the study is compliant with the protocol, Good Clinical Practice (GCP), and relevant regulatory requirements.