We provide regulatory services throughout your investigational product´s development. Among our ongoing regulatory services our human subject protection specialists manage your clinical trial´s informed consent process by developing the informed consent and assent forms according to 45 CFR 46, 21 CFR 50, and ICH regulations, and by coordinating your IRB/IEC review and approval. Our medical writers work with the protocol team to develop your study protocol based on your, or TRI´s template. In addition to assisting you in drafting the protocol - defining the procedures to be used, describing the assessments that will be conducted to gather data, and defining the statistical and clinical analyses that will be performed - we also write and review protocol amendments. Finally, our regulatory team prepares periodic and final clinical study reports per ICH guidance.
- Clinical Development Phase I-IV
- Informed Consents and appropriate translations
- Clinical Study Reports