Our medical writers work closely with our project managers and the lead CRA to prepare documents that meet regulatory requirements on an ongoing basis throughout the entire study process. are informed by the knowledge Our writers’ knowledge of ICH guidelines and clinical study statistics informs the content and format of clinical study reports (CSRs).
We use a two-step process for CSR writing:
- Produce ICH-compliant CSR shell before the trial is completed so the client can review, edit and approve the format in advance
- Provide the client the first draft CSR within 4 weeks of database lock
- ICH-GCP compliant CSR
- Clinical and preclinical study protocols
- Informed consent forms
- Investigator brochures
- ISS/ISE (integrated summaries of safety and efficacy)
- Manuscripts, abstracts, poster presentations and summaries
- DSMB reports
Data ManagementWe offer real-time data management capabilities to clinical sites and sponsors via 100% web-based data collection.
PharmacovigilanceOur highly experienced clinical safety professionals provide clinical and medical expertise to evaluate the safety and conduct of Phase I-IV clinical trials.
Book a meeting or send us a message to talk to one of our experts.