docuvera: Global LABELING
Docuvera Global Labeling reduces risk and optimizes productivity.
Life Sciences companies consume a huge amount of resource and time managing labeling content contained in Core Data Sheets (CDSs), Package Inserts (PIs), and
Summaries of Product Characteristics (SmPCs). Content is often replicated in numerous labeling documents for varying drug indications, dosages and strengths. This results in a huge volume of highly complex labeling that can only
be overcome with complex processes and people. The issues are compounded by strict and evolving rules for the submission of labeling content to global regulatory entities.
Download this data sheet to see where Docuvera fits into your Labeling process.
docuvera: medical information
Rapidly design, build and deliver medical information across all communication channels using Docuvera.
As a global deliverable of Medical Affairs, medical information is used to disseminate trusted clinical and scientific information on drugs and medical devices to Healthcare Professionals (HCP), patients and government regulatory entities. Medical information is distributed through multiple content outputs such as standard responses, FAQs, dossiers and presentation/ speaker decks across a spectrum of delivery channels. The accuracy of these information products is crucial to ensure message consistency and regulatory compliance. Changing regulatory standards and geographic localization challenges introduce significant risk, errors and threats of omission to content that historically can only be addressed by complex authoring processes.
docuvera: FOR REGULATED DOCUMENTS
A single platform to author, review, approve, translate, reuse and publish components of content to regulated documents.
The pharmaceutical industry is dependent on regulated documents to ensure compliance in a highly regulated environment. As regulations change, become more complex and diverse, so do demands on the business to ensure compliance. This makes the development and maintenance of required, regulated documents increasingly difficult. This reality has the potential to expose pharmaceutical companies to a higher risk of compliance failure.
Docuvera Clinical improves quality and compliance of clinical operations
Clinical trial documents are complex, yet their creation represents a series of essential steps in bringing products to market. Numerous documents are created to support a clinical trial and content is frequently reused across the set of pre-clinical and clinical documents. Long clinical development cycles, regulatory and ethics requirements and the high cost of rework ensures that clinical documentation is the focus of heavy scrutiny. However, the traditional approach to authoring and managing clinical information via a document metaphor does nothing to reduce the burden on authors or facilitate reuse of information across documents.
docuvera: Aggregate Reporting
Docuvera for Aggregate Reporting and Safety Writing improves quality and consistency of pharmacovigilance documentation across all stages of the product lifecycle
Ongoing pharmacovigilance is essential to the development of safe medicines, required to introduce them into the market and ensures their survival in the market once approved. However, because authoring and management of aggregate reports represents one of the most time and resource intensive pharmacovigilance regulatory requirements, pharmaceutical companies are exceedingly interested in technology solutions that help to alleviate this burden. Unfortunately, the traditional approach to authoring and managing aggregate reports via a document metaphor does nothing to reduce the burden on authors or facilitate reuse of information across safety documents.