Medical Writing & RA Services
We have experienced and highly trained in-house medical writing professionals responsible for preparing the study documents in line with regulatory guidance and with the sponsor’s requirements.
- Feasibility assessment
- Protocol and its amendments
- Informed consent documents
- Case report form
- Investigator’s brochure
- Patient diary
- Clinical study reports
- Common Technical Document (CTD) for EU and US Regulatory Authorities
At KHBR, we have a dedicated team that focuses on the clients regulatory requirements, that needs to be fulfilled before a clinical study is initiated. We work together to assist our sponsors with complex regulatory issues, pathways, regular tracking of the application status along with changing requirements to ensure study related approvals are in place, in a timely manner.