PointCross - Pre-Clinical Study Lifecycle and Data Management Solutions for Multi-Party Enterprises

PC-LDM™ - Pre-Clinical Study Lifecycle and Data Management Solutions for Multi-Party Enterprises

PointCross’ Pre-Clinical Study Lifecycle and Data Management (PC-LDM™) solutions represent a group of related solutions within its larger IDDS (Integrated Drug Development Suite) offering. The PC-LDM solution stack provides Pharmaceutical and Biotechnology companies with a single, secure environment within which the lifecycle of all pre-clinical studies can be orchestrated within the confines of an individual company, or across the extended enterprise including CROs and other partners.

PointCross’ PC-LDM offering is built on Orchestra™, a scalable, secure SOA platform that provides core capabilities 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.

PC-LDM also allows companies to securely interact with relevant Regulatory Agencies around their pre-clinical study submissions. It can also be used by CROs to manage interfaces with their clients. PC-LDM is available either as a SaaS (Software-as-a-Service) model, or can be deployed within the enterprise.
Key features of the PC-LDM solution stack include:

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
Genotoxicity and others

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 driven by the underlying Orchestra ontology engine (see figure below). This Semantic Data Exchanger allows data and other information – both legacy as well as from on-going studies - to be contextualized within Orchestra.

Click here to enlarge

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
Analysis toolkits with graphing and tabular views, as well as data exchange (into statistical or other data mining packages), and slice & dice capabilities
PC-LDM can be configured as a stage-gated maturation process for all pre-clinical studies including:
- Define – 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.
- Pre-Submission Preparations – where study findings, annotations and applicable datasets are prepared in accordance with regulatory filings; and where pre-submission team reviews can be undertaken and decisions logged.
- Submission – where interactions with relevant Agencies with challenge-response questionnaires and workflows are facilitated in an ultra secure data room environment.
Provides a Universal Data Exchange (UDE) toolkit 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 again using Orchestra’s Semantic Data Exchanger. This involves mapping of the internal ODMs to other required data models, and extraction/export of relevant data/annotations and findings into the required formats, together with audit traceable logs.
- UDE also allows publication of relevant information to other related IDDS processes as well as PointCross’ CRO-BOS (CRO Business Operating System).
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). This is a standard feature of the Orchestra platform.
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.
Business Information Framework (BIF) facilities across the entire lifecycle using the Orchestra platform with in-built support for communications, data and content management. The BIF facilities include the ability to structure and represent studies contextually, and to create and re-use corporate templates tied to the study type.
Secure search facilities across the lifecycle using Orchestra’s Codetta technology – these facilities provide rapid character matching, contextual linkages (to locate related information), expertise (in terms of people involved with the relevant or related studies), and content (data, analysis outputs, findings, and submitted packages).

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