IDDS-RS - Regulatory Submissions
PointCross’ Regulatory Submissions solution manages the lifecycle of communications, documents and data for regulatory processes and compliance. It is part of our larger Integrated Drug Development (IDDS) suite.
IDDS-RS benefits companies by contextually organizing information, breaking down traditional information silos, mitigating risk, and reducing the time and effort required to prepare and submit regulatory packages. It allows companies and their compliance/legal personnel to rapidly discover and sequester all information pertinent to regulatory matters allowing audit and eDiscovery responses to be streamlined.
IDDS-RS is typically configured as a stage-gated process for the capture, preparation, review and submission of data and document packages related to regulatory compliance processes for drugs, biologics, and medical devices. IDDS-RS spans the entire lifecycle of submissions – for traditional drugs, this includes discovery, early development, clinical trials, and post-marketing studies, pharmacovigilance and ongoing facility monitoring and manufacturing process controls. Similar facilities are available for regulatory submissions related to biologics and medical devices.
IDDS-RS provides all the contextual communications (emails, meeting notes, and blogs), search, security and compliance facilities required by people responsible for orchestrating regulatory submissions. It also interoperates with existing corporate systems.
IDDS-RS is built on Orchestra™, a scalable, secure platform that unifies information and services that employees need, as they consult and work with their colleagues, outsourced service providers, and other stakeholders in the course of managing regulatory submissions.
Key features of IDDS-RS include:
- Configurable stage-gated maturation process for the preparation, review and submission of regulatory processes
- Unified Business Information facilities across the entire lifecycle using the Orchestra platform with in-built support for communications (emails, meeting notes, blogs), data and content management
- Capture study protocols, reports, analysis datasets, findings, annotations and applicable datasets in accordance with standard templates for Agency submissions (e.g., eCTD or other templates required by EMEA, Japanese Ministry of Health and other country-specific agencies)
- All information within IDDS-RS is accessible on strict role-based need-to-know role basis, and subject to strict audit traceable controls in accordance with specific regulatory compliance and internal corporate governance requirements
- Data exchange facilities with document management systems, data management systems (including LIMS and databases), and statistical applications
- Interfaces, Web and/or SMTP (email) data capture and related workflow services to allow documents and data to be extracted and collected from other applications, internal or external to the organization, with complete audit traceability. Interfaces to exchange information with CROs or other strategic suppliers are also managed
- Secure search facilities across the lifecycle using Orchestra’s Codetta technology – these facilities provide meta-data search, content search, semantic search and structured queries within and across regulatory matters. The ontology engine within Orchestra preserves relationships to related matters - for instance, all the submissions related to a particular drug over its entire lifecycle. Links to related experts and scientists are also available
- Comprehensive XML-based Operational Data Models (ODMs) maintained using Orchestra’s ontology engine
- Ability to capture and manage all data in vendor neutral XML format, and publish to CDISC or HL7 standards, as well as other agency required formats
- Ability to support industry/Agency/Standards Body Controlled Vocabularies using linkage capabilities among multiple terms (synonyms) that exist across different taxonomies and/or “folksonomies” that exist and evolve within organizations
- Information Security – in terms of authorized access strictly on a role-driven need-to-know basis for the capture, storage and transmittal of information
- Audit traceability with event tracking and logging, and data/time/user stamps across the entire regulatory lifecycle
- IDDS-RD is delivered through online web interfaces, SharePoint portals, Outlook/Office 2007/2003, and mobile devices – all with the same controls for search, security and compliance.
- IDDS-RS is available either as a SaaS (Software-as-a-Service) model, or can be deployed within the enterprise.
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