We offer a range of early phase contract research organization (CRO) services executed by professionals fully dedicated to your early development program.
These services include:
- Protocol design and early phase concept and program development
- Protocol writing
- Regulatory and pre-IND/IND meeting consultation services
- Scientific consultation
- Multi-site feasibility support based upon established QA-approved site network
- Dedicated Phase I/early development project management group
- Phase 1 focused data management
- Biostatistics and statistical design planning specific to early development studies
- Pharmacokinetics
- Clinical monitoring
- Pharmacovigilance
- Site management
- Medical writing