Achieve compliance with one integrated team for all your safety and PV document needs
Fragmented teams and hand-offs through your product’s lifecycle can result in errors that lead to significant risk of non-compliance of regulatory process requirements and patient safety.
Confidently achieve safety-related document compliance with a seamless integrated team powered by technology. Synchrogenix’s safety and pharmacovigilance experts deliver project management, data analysis, medical writing, and medical review capabilities around-the-clock.
Our team supports safety-related document authoring throughout the entire safety lifecycle for major global agencies. This includes patient safety narratives, eCTD documents (2.7.4, ISS), aggregate reports, risk management plans, cumulative safety analysis, literature searches, global value dossiers, and signal evaluations.
CoAuthor introduces technology-enabled authoring into the patient narrative writing process.
Anticipate challenges
Synchrogenix’s safety and pharmacovigilance experts combine deep expertise with responsive, customer-centric processes to assure patient safety and report compliance.
- In-depth regulatory knowledge enables streamlined, yet thorough compliance to regulations and guidelines
- Flexibility to meet changing requirements and tight timelines
- Proactive management of project timelines
Proven record of success with safety-related documents
Our team authors all safety-related documents required throughout the drug development lifecycle, including patient safety narratives, eCTD documents (2.7.4, ISS), cumulative safety analysis, literature searches, global value dossiers, and PV documents:
- Development Safety Update Reports (DSURs)
- IND Annual Reports
- Risk Management Plans (RMPs)
- Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs/PADERs)
- Addendum to Clinical Overview
- Signal assessment reports
- Safety analysis document/reports
- Patient Safety Narratives
- CCDS
- Benefit-Risk Analysis
Tech-enabled Patient Narratives
Power your safety reporting by applying our experts and technology-enabled service delivery. Reduce time to completion of large narrative projects while providing consistency.
- Our experts engage CoAuthor’s narrative builder features to efficiently manage thousands of narratives to full completion, including review, in a fraction of the time
- Templates can be developed/tested with pre-Database Lock data with no additional work required using post-Database Lock data
- Gain speed, quality, and consistency across your narrative set
