A dedicated medical writing team at Scitus, not only prepares study protocols in line with the sponsor’s requirements and applicable regulatory guidance, but also suggests appropriate study designs with scientific reasoning to ensure generation of quality data. The medical team also coordinates with the ethics committee for necessary approvals.
Medical Writing
Service Highlights
- Well experienced team of medical writers with expertise in various therapeutic areas
- BA/BE studies are conducted in extremely controlled environments and all activities are strictly driven through SOPs
- Expertise in delivering the project on time with a turn around time of 45 days from the initiation till the final report.
- Studies conducted are approved by the Independent ethical committees, and all the procedures in clinical and bioanalytical divisions are SOPs driven, in accordance with current GCP, GLP standards and applicable regulatory requirements.
Documents prepared
- Protocol, Informed Consent Form (ICF) and Case Report Form (CRF) for pharmacokinetic/clinical endpoint studies
- Clinical Report, Bioanalytical Report, Method Validation Report and Statistical Report
- Integrated Study Report in eCTD format with hyperlinking & bookmarking
- CDISC report and FDA summary tables for ANDA submissions
- CD-ROM copy and hard copy of reports and associated study data
- BENOC application submission documents on need basis
