Writing a protocol for clinical research is an arduous process that requires a lot of time and effort. A protocol is described by Health Canada as a document that describes the objectives, design, methodology, statistical considerations and organization of a clinical trial. It is also a required document needed for Regional Ethics Board approval. dicentra’s team of regulatory experts have extensive experience with preparing clinical protocols and can help you design and develop the best possible protocol for your clinical trial
Services offered:
- New protocol development
- Informed consent document preparation
- Manage Clinical Trial Applications
- Manage submissions for IEC / IRB approval
- Assist with preparation and approval of protocol amendments
- Regulatory & Quality review
- Medical Writing
Contact us to learn more about our protocol development services