Documentation specific to your trial’s needs.
TD2 provides a full suite of scientific and regulatory writing to address your program’s needs. Our team of medical writers and therapeutic experts work with you to develop documents in compliance with GCP and ICH guidelines. In addition to technical writing for all IND modules, we develop clinical trial protocols, Informed Consent Forms (ICF), Investigator’s Brochures (IB), Clinical Study Reports (CSR), as well as abstracts, manuscripts and more.
- Abstract and manuscript completion
- Drug development plans
- Investigator brochures
- Protocol synopses, full protocols and protocol amendments
- Informed Consent Form (ICF)
- Clinical study reports
- Interim data summaries
- FDA pre-IND meeting request and briefing packages
- Investigational new drug application (IND) (technical writing for all IND Modules 1-5)
- Abstracts and manuscripts