Essential Automation for Faster and More Accurate Trials

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investigatorFIRST – the only automated essential document exchange deployed by global pharmaceutical companies.

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 10 years.

Today the largest pharmaceutical firms in the world use InvestigatorFIRST 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.

Metrics

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

Live Document Transactions

Production Trial Sites

Production Trials

Products

investigatorFIRST / Count on investigatorFIRST to handle your clinical document exchange with investigator sites at study startup and during conduct. investigatorFIRST automatically handles distribution of pre-configured document packages to investigator sites 24 x 7 x 365 without the need for human intervention, providing an unparalleled level of efficiency and compliance.

investigatorFIRST + cSafety / For your critical safety documents, use the cSafety module to handle global distribution to your investigator sites and ensure the highest level of compliance. Integrate with Argus or ARISg for a fully automated pipeline.

Deploy the full suite to meet all of your clinical and safety needs for your investigational 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.

Frequently Asked Questions About eTMF Automation

How can we truly go paperless if trial sites prefer wet signatures?


The short answer is that you don’t have to force sites to go paperless. We have found that tens of thousands of users at sites using our InvestigatorFIRST software were thrilled to go paperless, including eSignature, once they logged in to the portal and saw that it supported both wet signature and eSignature.

There is always a bit of cultural change required when technology advances. But in this case our customers learned sites become the biggest advocates once they experience how much time can be saved by moving away from wet signatures. However, when sites do execute wet signatures, our software sends that document with it’s wet signature into a special QC check. Once the wet signature is approved, that document and it’s wet signature continue to move along as a paperless document.

Do you have any stats on how long it takes for a document in your system to go from site collaboration and collection to eTMF?

During paper based trials, essential documents can take 40 to 60 days from scan until final QC check, prior to adding them to your eTMF system. Our InvestigatorFIRST solution eliminates all the paper based steps, including printing, signing, scanning, and scan inspections. That means when a document is distributed by our system, depending on whether or not it needs a signature, the document is ready for a final QC immediately or upon eSignature a few days later. This process includes the documents collected from the Sites. The eTMF can receive documents immediately after a single QC review. Timeliness and contemporaneousness become the default status of your eTMF.

How much time does a CRA need to spend in your system to review the site binder during a monitoring visit?

Because InvestigatorFIRST is automated and paperless, completeness is decoupled from site monitoring visits. There is never a reason to check the binder at a site because the binder can no longer be out of order, it wont be missing an artifact, and it can’t contain an outdated document. Site Binders are always in a state of completeness.

If a site needs to sign or acknowledge anything, the sponsor is already aware of the missing signature or acknowledgement without a site visit. And the site is aware of their incomplete task because it is the first thing they see when they login. For these reasons, CRAs can spend time at the sites doing more productive things than reviewing paper binders.

Does your system send out a lot of emails to sites? Don’t paperless systems send out way too many reminders upon reminders?

Our customers usually set up investigatorFIRST to send once per week digest emails that contain clickable links to any actions that need to be taken care of. This strategy not only solves the issue of getting too much email, but it also gives sites a chance to get their work done without getting reminders from a system that doesn’t know whether the site already took care of a task. When we launched “Digest” messaging in version 6 of the InvestigatorFIRST, our site user productivity increased, and task cycle time dropped. It is a good balance between harping on users and helping users complete their work.

Study Startup has a lot of sub-processes. How does your software deal deal with the complexity of distributing and collecting the variety of startup documents?

A recent ACRP article on study startup said it best, “a large chunk of start-up effort is spent on coordinating the essential document compilation, review and reconciliation steps required for various submission packages”. Automating startup essential document workflow is complicated because there are 8 different essential workflows in every study and a study startup package contains at least 4 of them.

This is exactly where InvestigatorFIRST provides maximum benefit and efficiency. Our purpose built workflows are automated and they require no configuration as they route correctly, right out of the box. From trial start to trial finish, InvestigatorFIRST eliminates the study startup paper ISF, and manages a paperless compilation and automated distribution of the package as it tracks the package status in real-time until completed.

How can we effectively track and approve the Informed Consent that is being edited by the site prior to site startup?

The collaboration workflow built into the Study Collaboration Portal enables the site to edit the Informed Consent provided by the sponsor and send it back to the sponsor for approval. The sponsor can provide feedback or approve the document. Once the document is approved, it is locked and cannot be edited. The site can then submit the document for IRB/EC approval, provide IRB/EC feedback to sponsor and finally upload the IRB/EC approval letter back to InvestigatorFIRST. All versions of the Informed Consent along with changes made at every stage are maintained in an audit trail.

How do you handle the Closeout document collection process?

During the closeout process, all study files are reconciled with the Trial Master File. This used to be a painstaking and time-consuming process. However, InvestigatorFIRST has completely automated this process by designing a system that keeps essential documents validated at all times and transferred to the eTMF for QC in real-time. However, any missing document, such as study team licenses, CV’s, laboratory documentation, etc. will be available as an open task for the site to complete.

The CRA can simply monitor everything remotely during the trial to ensure the site completes all required documentation in a timely manner, long before closeout. Once a site’s role in the trial is complete, the sponsor has the ability, in one click, to archive all documents and communication provided to the site during the conduct of the study and provide that archive to the site. All documents and correspondence are automatically converted to PDF for long term retention by the site.

Why should I consider InnovoCommerce over [fill-in-the-blank]?

We don’t mess around when it comes to designing and building great software. We have been delivering enterprise scale software for drug safety, device complaint handling and clinical trials since 1995. Our team envisioned the Argus Safety product  in 1996 and launched it to the world in 1998. (At a time when there were many other companies already offering software for adverse event handling.)

Today, InvestigatorFIRST is the only commercial software to deliver end-to-end automation of regulatory document distribution and exchange from study startup to study close out. Our customers are years ahead of their competition by using our product.

You can count on us to deliver a scalable enterprise solution to your trial document challenge, You don’t have to build your own. Contact us for a demonstration today.

Can you validate our installation?

Sure can! We can provide a spectrum of go-live support from supplying baseline validation templates to designing and executing your validation scripts for you. Every deployment starts with a set of project templates and other standard artifacts like administration guides, validation guides, and a functional design specification. Then we work with customers through pilots to identify gaps and find what they need to get the system up and running. Check our deployment models below.

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.

Technology

Our InvestigatorFIRST 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.

InvestigatorFIRST 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, investigatorFIRST 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.

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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