- Pharmacovigilance documents such as Periodic Safety Update Reports
- ICH GCP compliant Clinical Study Reports (CSR); Phases I to IV, including CSR Synopses for public disclosure
- Clinical and non-clinical sections of the Common Technical Document including overviews and summaries for US and EU Regulatory Authorities
- Study Protocols
- Investigator Brochures
- Patient information documents including Patient Brochures and Informed Consent
- Patient Safety Narratives
- Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a Contract Research Organization (CRO)
In addition to these services, CodeArc can support clients in the traditional study service model. We have processes in place to ensure strong communication and a proactive approach to improvement of the team that is involved at the study, program, and sponsor level.
CodeArc also has extensive experience working with other CROs, vendors, and study teams to support clinical, safety, and marketing programs. These partnerships allow CodeArc to support a full service CRO approach. This includes employees with experience across many therapeutic areas, and across Phase I, Phase II/III and Phase IV/ Post-marketing studies.
