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.

Synchrogenix™ Writer 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
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Anticipate challenges
Proven record of success with safety-related documents

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
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Tech-enabled Patient Narratives

通过应用我们的专业和技术支持的服务交付,为您的安全报告提供助力。减少完成大型叙述项目的时间,同时提供一致性。

  • Our experts engage Synchrogenix™ Writer’s narrative builder features to efficiently manage thousands of narratives to full completion, including review, in a fraction of the time
  • 可以使用预数据库锁定数据开发/测试模板,无需使用后数据库锁定数据进行额外操作
  • 加快遍历叙述集的速度并提高质量和一致性
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Tech-enabled Patient Narratives
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