Clinical Trial Support
Q: What extent of support can SRC provide a small company who wants to conduct a clinical trial?
A: SRC has a team of experts, who can provide the complete range of services to conduct small clinical trials, including writing protocols, informed consent forms clinical study reports and monitoring of the site during the study. SRC can also provide management of all interactions and submissions to IRBs and the FDA, required for the clinical study.
Manuscripts and Medical Writing
Q: We are considering publication of our clinical trial results. What support can SRC provide?
A: SRC includes a team of experienced medical writers, who have authored over 100 manuscripts over the past 10 years. We can create the manuscript from scratch, and include full literature searches and reviews so the manuscript is complete and cutting edge.
Q: What support can SRC provide in regard to clinical study reports?
A: SRC can write the complete CSR, compliant with ICH guidelines. We normally start with tables, listings and graphs, and can take it from there. Experienced medical writers are assigned to your team, and stay with the project.
Q: We have an outline for a clinical study protocol, and want to confirm it will be accepted by FDA. Can SRC help us with this?
A: SRC would provide a review of the protocol to confirm compliance with the regulations, and then manage interactions with FDA to confirm acceptance. Recommendations might include a PreIND meeting with FDA, to confirm acceptability of the clinical study protocol, as well as other planned elements of the project.