PRODUCTS

InnovoCommerce eClinical products help Life Science companies manage documents, data and collaborative processes in an FDA-compliant manner. Our product framework, innovoPOINT®, leverages the Microsoft® SharePoint® platform and helps organizations deftly adapt in a rapidly changing regulatory landscape while continuing to meet core line-of-business needs. In short, any Life Science firm or other business under compliance regulation will benefit from innovoPOINT®.

innovoPOINT® Clinical and Investigator Portal

As clinical research becomes increasingly complex, global and costly, organizations are seeking portal solutions that can be deployed in an agile, quality-driven and cost-effective manner to achieve a high return on investment (ROI). innovoPOINT is the world’s leading clinical and investigator portal built with Microsoft SharePoint technology. The product helps improve clinical operational compliance, boost productivity and clinical efficiency and significantly lower costs in the clinical study process. And innovoPOINT is built for rapid deployment and validation. Competitive solutions can take over two years to be deployed; a full implementation of innovoPOINT can often be achieved in in six months or less. Consequently innovoPOINT is unmatched if clinical organizations seek rapid results to realize return on investment. The innovoPOINT solution includes:

System Administration

	Automated clinical trial provisioning with out-of-the-box portal site templates, sub-site templates, document libraries, metadata, lists and workflows
	Self-service management of passwords and user account requests
	New user creation with guided workflow
	Highly scalable external user identity database management
	Ability to invite potential investigators to the portal to enter their basic information and site details
	Administrative super user system monitoring, usage and audit trail reporting

Training

	Centralized repository for all general training content as well as trial-specific training content
	Multiple training content formats supported (i.e. Office formats, HTML, XML, etc.)
	Support of various relevant standards (i.e. SCORM, etc.)
	Configurable training workflows and alerts
	Certificates of Completion provided for each training module completed successfully by the user
	Training overview reports and audit trail with trainee, date, time, training name and status

Secure Document Exchange

	Configurable, granular security with secure encrypted transport
	Best practices clinical document exchange taxonomies
	Study Start Up document exchange packages
	Configurable security, workflow and distribution rules
	Electronic signatures
	Site and study document status tracking and reporting
	Full audit trail (participant name, role, date and time stamp, activity in the system, i.e. read and understood and electronic signature record)

Safety Document Distribution

	Secure, controlled central repository for published safety content including IND, ADR, SUSAR and SAE safety reports
	Configurable notification automation upon new safety document posting
	Ability for investigators with the appropriate rights to securely upload SAE report in real time for immediate CRO or sponsor consumption
	Configurable security, workflow and distribution rules with “read and understood” prompts
	Full audit trail (participant name, role, date and time stamp, activity in the system)

Site Feasibility and Qualification

	CRO- maintained investigator list in centralized database
	Customizable questionnaire to collect basic investigator data
	Ability to invite potential investigators to the portal to enter their basic information and site details
	Electronic feasibility questionnaire to perform prospective investigator screening against protocol requirements
	Optional analysis of feasibility responses
	Sponsor-controlled investigator and study management

Site Monitoring

	Creation and tracking of site issue logs
	Workload/assignment of sponsor CRA or CRO monitoring resources to sites across multiple studies
	Site visit report generation and follow-up letters
	Configurable range of standard trip report templates (i.e. pre-initiation, study, closeout, etc.)
	Auto-created trip reports via data fields

innovoPOINT dm® Regulated Content Management with Clinical Focus

Life Science firms increasingly consider the SharePoint® platform a valuable means to collaborate and to manage and control key documents and information. Existing content management systems are overly expensive, not easily deployed, and often difficult for the business user to navigate. InnvoCommerce’s innovoPOINT framework helps Life Science firms eliminate these challenges. The innovoPOINT framework is used in the following areas:
 

innovoPOINT for R&D
innovoPOINT for Quality
innovoPOINT for Clinical Documents and eTMF foundation
innovoPOINT for Product Promotional Management
innovoPOINT Corporate Compliance
innovoPOINT Contracts Management

ALEA™ Integrated Response Technology (IRT)

ALEA IRT screens, randomizes and manages study medications to cover the most critical clinical trial functions. Proper enrollment and drug management can have the greatest impact on study performance, project timing and final deliverables. To achieve this, the ALEA IRT System provides you with ready-made eClinical Applications that require no custom code. ALEA IRT lets you configure each application to the specific parameters of your clinical trial. This results in a significant reduction in project setup time, test script complexity, and the turnover date for user acceptance testing.
The ALEA IRT System is most appreciated by clinical teams needing to reduce costs by leveraging trial standards and reusing ALEA’s built-in component reuse functionality on future trials. The ALEA IRT System is bundled with plug-and-play components to give you the most flexible IRT solution in the industry. The ALEA system was developed utilizing Microsoft’s standard .Net technology stack and ports seamlessly to the Microsoft SharePoint-based innovoPOINT.

Collaborative Decision Making:

Life Science enterprises currently do not have collaborative systems that bring together Development, Medical Affairs, Finance, Legal, Business Development, and Marketing to facilitate and foster collaboration and data sharing when the enterprise considers whether to develop, license, or acquire new compounds and devices. Point solutions are in place; unfortunately they often help maintain information silos. By leveraging SharePoint and the innovoPOINT framework, Life Science companies can introduce a guided, yet intuitive, collaborative decision making process to facilitate new product development and portfolio management. The innovoPOINT framework is used in the following Collaborative Decision Making areas:

innovoPOINT for New Product Development
innovoPOINT Portfolio Management