IDDS-Study Management System for Pre-Clinical Studies
PointCross’ Study Management manages business processes for maturing studies, extracts and uses data from existing systems, and provides search, security and compliance related capabilities for structured and unstructured information. It is part of the larger Integrated Drug Development (IDDS) suite. IDDS-SMS is available for both pre-clinical studies, and can be configured for clinical trials.
IDDS-SMS 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 defining, executing, analyzing and interpreting pre-clinical studies.
A light version of IDDS-SMS, PointCross SEND-IT™, is also available for sponsors and CROs involved who wish to extract data from existing data acquisition systems, validate datasets against the SEND standard, and visualize datasets for regulatory submissions of non-clinical data.
The full IDDS-SMS solution is typically configured for managing the lifecycle and data associated with pre-clinical studies (including legacy systems). It provides sponsor companies with a single, secure environment within which the lifecycle of all pre-clinical studies can be orchestrated within their firewalls, or across the extended enterprise including CROs and other partners. IDDS-SMS for pre-clinical studies can also be used by CROs to manage interfaces with their clients.
Key features of IDDS-SMS for pre-clinical studies include:
- The ToxVision analysis toolkit with graphing and tabular views, as well as data exchange (into statistical or other data mining packages), and slice & dice capabilities
- Unified Business Information facilities across the entire lifecycle using the Orchestra platform with in-built support for communications (emails, meeting notes), data and content management.
- 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 studies. Links to related experts are also available.
- Comprehensive internal XML-based Operational Data Models (ODMs) maintained using Orchestra's ontology engine with multiple taxonomies for all types of pre-clinical studies including:
- General toxicity
- Carcinogenicity
- Reproductive studies
- Other types of non-clinical studies
- Ability to capture and manage all data in vendor neutral XML format
- Ability to dynamically add any number of additional ODMs into the solution stack on the fly; each of these can be further defined and extended to include evolving scientist and study requirements
- 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
- Ability to accept and validate structured pre-clinical data from any external source
- All external data structures are mapped to the internal ODMs using semantic mapping technology and exchange services. This Semantic Data Exchanger (SDE) allows data and other information - both legacy as well as from on-going studies - to be contextualized within Orchestra.
- Provides optional interfaces, Web and/or SMTP (email) data capture and related workflow services to allow study data to be extracted and collected from other applications, internal or external to the organization
- IDDS-SMS for pre-clinical studies can be configured as a stage-gated maturation process. The following are typical phases in this process:
- Define Protocols - where studies are defined in terms of study protocols, applicable GLPs, systems, as well as programmatics (cost, schedule and resources/expertise).
- Execute - where studies are executed with pre-specified or routine reporting/study data updates including deviations, exceptions and other relevant study information.
- Analyze - where studies are analyzed and interpreted; where key decisions regarding inclusion or exclusion of parts of, or entire datasets, are captured together with annotation capabilities; and where reports and supporting statistical analysis are tied into the overall study package.
- Report - where study findings, annotations and applicable datasets are prepared in accordance with standard company reporting templates;
- Ability to publish study findings, analysis, reports and relevant datasets into multiple formats for Agency or other regulatory filings, or into other industry applications for analysis.
- Various regulatory Agency required formats for study submissions are supported
- Additional output formats can be defined and configured using Orchestra's Semantic Data Exchanger.
- Information Security - in terms of authorized access strictly on a role-driven need-to-know basis, storage and transmittal (from Pharma company to CROs, vice-versa, as well as between Pharma companies and regulatory Agencies or other third party providers).
- Audit traceability with event tracking and logging, and data/time/user stamps across the entire lifecycle from inception, through transmittals in various formats, their conversion into standard ODMs, validations, exclusions, basis for analysis and interpretation, and into submissions.
- IDDS-SMS 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-SMS is available either as a SaaS (Software-as-a-Service) model, or can be deployed within the enterprise.
Schedule a time to meet with a representative
