Pre-clinical and clinical summaries and overviews
Marketing approval for your product depends on complete, consistent and compelling documentation, including detailed, integrated submission summaries and overviews. These key components of a submission should clearly and uniformly convey to regulatory reviewers how the benefits of your product outweigh the risks. Accovion’s data-driven approach can help to build a strong case for your product.
Maximize the probability of a fast marketing approval with detailed and persuasively presented submission summaries and overviews. Accovion’s Medical Writing team, in close cooperation with Biostatistics, offers integrated, succinct analyses of your product’s benefit-risk ratio across all studies in your development program. Choose Accovion as your preferred partner to create all or any portion of your product’s submission modules.
- Assess deficiencies or gaps in documentation and work with you to find acceptable solutions
- Consult with Biostatistics on optimum data presentation and possibility of pooled and meta-analysis
- Create summaries according to available data from all clinical study reports, pooled analyses and meta-analysis
- Create overviews consistent with summaries, including discussion of benefit-risk ratio across all studies
- Project management of all documentation or of the entire submission
- Electronic compilation, hyperlinking and publishing of your submission (eCTD)
- Creation of a global integrated data base (GIDB) in cooperation with Programming services
- Pooled analyses, statistical analysis plans for pooled analyses and meta-analysis in cooperation with Biostatistics services
A professional collaboration with Accovion means you’ll receive fully compliant, submission-ready documentation on time and within your budget. We can work independently to manage and produce all aspects of your submission or in cooperation with your designated team. Take advantage of Accovion’s extensive experience and resources to assist you with all of your worldwide regulatory submission needs.