ACI’s medical/regulatory writing staff has a track record that is second to none in rapidly developing lengthy technical documents in all major therapeutic categories.
Specifically for Regulatory Writing, ACI has worked on a wide range of CSRs, protocols, AE narratives, INDs, NDAs, SNDAs, BLAs, briefing documents, safety reports, CMC reports, 505 (b) (1) and (2), and other items for submission to FDA and international regulatory bodies. We also offer selected regulatory consulting services.
Meetings
Our firm offers the unique combination of logistical as well as editorial strength to ensure smooth-running programs and on-target content.
Biostatistics/Data Management
ACI offers full spectrum of services from protocol and CRF development to data entry, analysis, and final reports.
ACI has extensive experience with phase II and III trials, post-marketing studies, and post-hoc data analyses.
Digital Media
ACI offers design and implementation for websites, videos, interactive PDFs, and marketing programs.
ACI offers large company experience and capabilities, with small company service, flexibility, and costs.