- Available for consultations on study implementation/study conduct
- Study Start Up, including coordinating sponsor site selection and site initiation visits
- Preparation and submission of regulatory applications:
- Institutional Review Board materials such as IRB initial application, Informed Consent, amendments etc.
- Other regulatory submissions, as applicable to the study
- Regulatory binder creation and organization
- Development of data collection forms/source documents
- Development of standard operating procedures and study manual of operations
- Research project coordination
- Research participant recruitment and screening
- Facilitating research visits and assistance with data collection at study visits
- Sample processing & coordinating shipment of research specimens
- Facilitating study monitoring visits
- Data management, including completion of Case Report Forms (CRFs)/eCRFs, data entry, data cleaning
- Study Closeout Support
