Essential Automation for Faster and More Accurate Clinical Trials

We are the creators of the:

Study Collaboration Portal™ (SCP)

SCP is Powerful and Paperless

1. Setup your study documents in SCP

2. Plug in the SCP to your eTMF

3. Selects trial sites and begin Site Initiation

Fast Site Initiation and Startup

1. Sponsor sends SSU Packages to new Sites

2. Sponsor and Site collaborate on documents

3. Site submits package to IRB /EC for approval, and then returns signed docs

Automatic SUSAR Distribution

1. SUSARs originate in your Global Safety System

2. SCP determines which sites are studying the drug

3. SCP sends a SUSAR to every Site and validates their receipt

Manage Protocol Amendments

1. Versions are automatically controlled. Old versions are not available

2. Automated essential workflow collects site receipt and eSignature

3. IRB/EC Approval automatically tracked when required

One Click Site Closeout

1. Sponsor can close a sites with one click, creating a PDF for site

2. Exports all version of essential documents, communications, etc.

3. All site related study files are auto reconciled throughout the study.

Automated eTMF Transfers

1. SCP connects to any Metadata driven eTMF mapping setup

2. Exports all version of essential documents, communications, etc.

3. Reduce current eTMF transfers from 60 days to 5 days.

SCP is deployed globally at top pharmaceutical companies

Start up a study in 30 minutes

Distribute SUSARs with one click

Manage completeness in real time

Add a new Site in 3 minutes or less

Give your CRA’s more time every day

Retire a site with the click of your mouse

The only secure document exchange that automates eTMF workflow from sponsor to site

Metrics

Sponsors and Sites all over the world are using Study Collaboration Portal to automate the flow of essential documents from Startup to Closeout!

Live Document Transactions

Production Trial Sites

Production Trials

Features

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Document Distribution

Automated, taxonomy-driven document distribution engine running 24x7x365

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eTMF Integration

Seamless, configuration-based integration to back-end eTMF systems such as Veeva, FirstDoc, and Wingspan

Auditing and Compliance

All actions are audited and traceable, ensuring high levels of compliance.

Training

Integrated distribution of training content and tracking of training completion

Trial Content Management

Supports management of key trial content such as news, FAQs, country resources, key contacts

Digest Email Notifications

Deliver the relevant content to users’ inboxes without bombarding them with too much noise.

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Electronic Signatures

Deliver the relevant content to users’ inboxes without bombarding them with too much noise.

Single Sign On

Integrates seamlessly with enterprise single sign on solutions such as Exostar and Office 365.

Purpose-Built Workflows

Proven safety and clinical process mappings designed to expedite work streams.

Comprehensive Reporting

Seamless, configuration-based integration to back-end eTMF systems such as Veeva, FirstDoc, and Wingspan

eISF Export

Easily package and export all site documents into a single electronic file for download and archival

Terms and Conditions

Integrated terms and conditions to capture user acceptance of enterprise, global, and regional policies

Enterprise Metrics

Captured in-flight, in real-time and allows enterprise wide view of process metrics and discovery of bottlenecks

Modular Architecture

Use the built in store, Amazon S3, Microsoft Azure Storage, or Box Enterprise as your backing store for your documents.

PDF Renditions

Configurable rendering of all content to PDF for archival and transfer to your eTMF.

Safety Report Distribution

Instantly publish safety reports globally and electronically track acknowledgements.

Find out about how these features help your clinical and safety operations align with industry best practices and guidance.

Deploy

InnovoCommerce offers multiple modes of deployment to fit your budget and regulatory needs.

Public Cloud

Run our software in a Virtual Private Cloud (VPC) in Amazon AWS or Microsoft Azure. InnovoCommerce can directly manage your environment or work with third party cloud managed services providers to get you up and running with minimal commitment.

Private Cloud

InnovoCommerce and our hosting partner will deliver a turn-key, compliant, validated, fully managed environment and deploy for you in a private cloud. Hybrid options allow you to store your documents with encryption in Amazon S3, Microsoft Azure Storage, or Box Enterprise to reduce your storage needs.

On Premise

You deploy the software on your private cloud or your infrastructure. You apply your security policies, leverage your existing IT teams, and existing environments. InnovoCommerce provides licenses, validation guidelines, documentation, and Hypercare Support to ensure a successful deployment and smooth operations.

Product Leadership

  • Secure and compliant, full automation of essential document exchange between sponsor and sites throughout the study lifecycle, Startup to Closeout, enabling Paperless Investigator Trial Master File (iTMF)

 

  • Cloud based technology and compliance controls ensure investigator control a d ownership of identity and electronic site binder  (EMA/ICH compliant)

 

  • Investigator and Site focused collaborative interface enables maximum site satisfaction

 

  • Realtime QC on site document collection process and eTMF integration

Technology Leadership

Our Study Collaboration Portal software is built on a graph based taxonomy, we can easily and naturally traverse the database from many different points of entry to ask different questions. This design makes our software lighting fast regardless of the task you are performing.

Study Collaboration Portal is designed from the ground up to meet the needs of the world’s largest pharmaceutical companies at an enterprise scale.

Unlike legacy systems used for document exchange or solutions built on legacy hierarchical structures, Study Collaboration Portal is built on a highly connected graph database capable of modeling billions of nodes and relationships.

Our unique architecture and functional design minimize duplication of documents to reduce the amount of storage you need to provide execute global trials while still meeting regulatory requirements. With the option of using Amazon S3, Microsoft Azure Storage, or Box Enterprise in place of the built-in document storage provider, you can achieve high scalability and high availability with minimal friction.

This allows unparalleled performance and the ability to meet the unique use cases in clinical and safety document exchange.

About

Established by the same team that launched Argus Safety in 1998, InnovoCommerce has been delivering industry-leading solutions in life sciences for more than 20 years.

Today the largest pharmaceutical firms in the world use Study Collaboration Portal to speed up and improve the accuracy of clinical trials. Organizations like Boehringer Ingelheim and Novo Nordisk are achieving paperless and fully automated eTMF workflow by offering our Study Collaboration Portal to thousands of their clinical trial sites.

There are so many reasons to connect our products to your clinical trials:

– Proven performance in full production across thousands of clinical trials, worldwide

– The only software solution that automates the 8 essential workflows required for a paperless, regulatory compliant eTMF automation solution.

– Scalable document distribution to support automation of millions of document exchanges between sponsors, sites, investigators, review boards and ethics committees.

– A safety letter distribution module designed to help organizations achieve greater compliance and transparency

– 21 CFR Part 11 compliant electronic signatures and signature manifestations

– Automatic electronic Investigator Site File (eISF) export

– Integration with eTMF repositories including FirstDoc/Documentum, Wingspan, and Veeva Vault

– Modular integration with Amazon S3, Azure Storage, or Box Enterprise for document storage

– Integrated training capabilities to enable ease of onboarding

We invite you to schedule a demonstration or our products and learn how we can help you achieve greater site satisfaction, stronger investigator relationships, effortless site and sponsor compliance, and improved clinical trial efficiency.

Contact Us

Get in touch with us to schedule a demo for your organization.

1 Technology Dr. / Suite #J725 / Irvine, CA 92618 USA

949-398-6550

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