- Postmarketing research is becoming increasingly important for maintaining drug approval, achieving appropriate reimbursement, and optimized clinical access.
- Trilogy can provide tailored consulting and writing of high-quality documents for your complete postmarketing program, including post-approval safety studies (PASS) and associated submission dossiers.
- We can assess and advise you on the types of studies that will generate the documents needed to meet your postmarketing goals, and provide you with all the documents necessary from programme start to submission to reimbursement bodies such as NICE or IQWIG, as well as to journals and congresses.
- We have the experience to effectively communicate about innovative study designs, complicated statistics, and reporting associated with postmarketing clinical data, offering you the best chance of success for your programme.
Our experience includes:
- Postmarketing development plans
- Phase 4 (late phase) clinical trial documents
- Comparative effectiveness research documents
- Observational study documents
- Quality of Life (QOL) research documents
- Health technology assessment (HTA) reports
- Reimbursement dossiers
- Health economics related documents
- Patient registries related documents