Clinical CRO support
We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.
Together with our clinical CRO partners, BioReg offers cost-effective solutions and consulting services that cover all the necessary steps before, during, and following clinical investigations.
We can provide the following clinical services:
- Clinical Investigation Planning
- Biostatistical Support
- Protocol Development
- Case Report Form (CRF)
- IC (Informed Consent)
- Center Identification (Feasibility)
- Liaison with Ethics Committee & Regulatory Authorities
- Management of Clinical Investigation
- Study Monitoring
- Budget Management
- Data Management
- CRF (Hardcopy Case Report Form) or EDC (Electronic Data Capture),
- Database setup, Data Integrity, and Quality Checks, Query Management, Final Data Cleaning, Database lock
- Clinical Study Report (CSR)
- Safety Management
- Patient narratives of SAEs
- Management of Study Events
For more information, please get in touch with the BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.