Makers of investigatorFIRST - the only commercial off the shelf clinical and safety document exchange system actively deployed by multiple global pharmaceutical companies.
Founded in 2008 by industry veterans from the Oracle Argus and CSC FirstPoint teams, InnovoCommerce has had a laser focus on delivering an industry leading clinical and safety document exchange system for the world's largest pharmaceutical companies.
Our mission is to help sponsors execute clinical trials with greater efficiency, transparency, and compliance while also making it easier to engage investigators and ease their burden of managing trial documents in fulfilling their compliance obligations to the sponsor and regulatory authorities.
Many of our competitors focus on BPO and professional services -- a philosophy of using more bodies to try to address the workload. Some of our competitors sell re-purposed products that ultimately result in process idiosyncrasies. Yet others sell concepts that haven't been proven in production. Our focus is on technology, engineering, and product first; our goal is to help our customers do more with less by delivering superior software that has been proven in production with hundreds of global trials.
investigatorFIRST is the only commercial off the shelf product actively deployed by multiple global pharmaceutical companies -- representing the world's largest -- to manage millions of clinical and safety document transactions with clinical investigator sites. Hundreds of documents are distributed through our system every day and tens of thousands of documents are transacted each month. Perhaps more significantly, according to CenterWatch site surveys, our customers are consistently ranked in the top 5 for investigator relationship quality.
Schedule a demo today to see how we help sponsors achieve greater site satisfaction, stronger investigator relationships, effortless site and sponsor compliance, and improved clinical trial efficiency.
The system is active and in production with users around the world transacting thousands of documents per day!
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.
Automated, taxonomy-driven document distribution engine running 24x7x365
Proven safety and clinical process mappings designed to expedite work streams.
Seamless, configuration-based integration to back-end eTMF systems such as Veeva, FirstDoc, and Wingspan
View document status by site, safety document status across programs, trials, countries, and more
All actions are audited and traceable, ensuring high levels of compliance.
Easily package and export all site documents into a single electronic file for download and archival
Integrated distribution of training content and tracking of training completion
Integrated terms and conditions to capture user acceptance of enterprise, global, and regional policies
Supports management of key trial content such as news, FAQs, country resources, key contacts
Captured in-flight, in real-time and allows enterprise wide view of process metrics and discovery of bottlenecks
Deliver the relevant content to users' inboxes without bombarding them with too much noise.
Use the built in store, Amazon S3, Microsoft Azure Storage, or Box Enterprise as your backing store for your documents.
21 CFR Part 11 compliant electronic signatures allow investigators to sign documents without the hassle of scanning.
Configurable rendering of all content to PDF for archival and transfer to your eTMF.
Integrates seamlessly with enterprise single sign on solutions such as Exostar and Office 365.
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.
How is investigatorFIRST different from an eTMF? Can I use my eTMF instead?
Think of your eTMF like an ATM and investigatorFIRST like a point-of-sale device. Sure, you can go to the ATM and take out cash every time you need to make a transaction, but it's far more convenient to use those funds by proxy at a point-of-sale with your credit or debit card. You can accumulate multiple transactions and then reconcile them as a record at the end of the billing cycle. Similarly, investigatorFIRST is designed to enable more fluid and transactional interactions with your investigational sites before the final record is pushed to eTMF; investigatorFIRST is a front-end proxy to your eTMF in the same way that a point-of-sale device and a credit card is a front-end proxy to your bank funds.
How does investigatorFIRST help investigator sites meet sponsor compliance goals?
Because this system has been used widely in production by multiple TransCelerate members over several years, we can confidently say that we've learned a lesson or two on how investigators use the system. We've combed years of web server logs to understand usage patterns. We've gathered feedback from our customers. We work closely with customers to understand user pain points.
What we've learned is that, in fact, investigators don't want to use the system; this is the same finding reached by a CTTI survey in 2016. Investigators are rightfully focused on their patients and managing their staff. One of the top challenges "one-and-done" investigators reported was a lack of time. We've designed the system with this in mind to make it more convenient for investigators to get just what they need via digest emails.
These periodic notifications keep investigators up to date on the latest documents and news without requiring them to log into the system unless there's an urgent task. Reminders are automatically generated and included in the digests as well. It's a delicate balance between overwhelming the investigators and trying to keep them engaged; we think we've found just the right balance.
This is just one example of how we are constantly compiling industry guidance and user feedback and investing that intellectual capital back into the software.
How does investigatorFIRST help my organization meet internal compliance goals?
Through a combination of automation and powerful reporting capabilities, we are able to help customers achieve high levels of compliance with low overhead compared to leveraging a BPO/hybrid solution, for example.
Our graph-based, taxonomy-driven distribution engine means that investigators get the right document, at the right time automatically and consistently. Enterprise metrics and operational reports ensure that study teams and global pharamcovigilance operations are always on top of the workstream. CTMS integration ensures that when sites and users are activated in CTMS, they get the documents they need, just-in-time. We don't make our money selling you more bodies; we make our money by selling you superior software.
What's this business about "graph-based" mean?
As far as we're aware, investigatorFIRST is the first clinical and safety document exchange system built on top of a graph-native database. Why a graph? When you think about a taxonomy of Programs-Trials-Sites-Countries, this is a natural graph structure; in fact, it is traditional relational databases that force a contortion of this taxonomy in other systems since this graph has to be normalized into a tabular structure.
Our graph based architecture ensures that site staff are connected to just the right content so they can effortlessly fulfill their trial obligations to the sponsor or CRO.
With a graph based taxonomy, we can easily and natrually traverse the database from many different points of entry to ask different questions.
How is investigatorFIRST priced?
InnovoCommerce works with customers to find the pricing model that works best to deliver value while ensuring customers can receive the highest quality support. Customers typically pay for an enterprise license and an annual support subscription. Email us today to schedule a demo or inquire about pricing.
How often is investigatorFIRST updated?
We release major builds 3 times a year and customers can choose their own upgrade pace. InnovoCommerce is committed to innovating and incorporating feedback from our customers and users into our product roadmap to continuously deliver better software. This may be odd coming from a vendor, but this is not our product; InnovoCommerce didn't invent this software. This product is the result of a collaboration with our customers to solve real business problems and it has been successfully deployed globally by TransCelerate members for several years now. This real world experience is reflected in the details and richness of capabilities and we continue to work closely with our customers to evolve the product, fill gaps, and improve with each release.
What's the difference between investigatorFIRST and Box or Intralinks?
In one word: efficiency. Box and Intralinks allow you to create repositories and workspaces, but do not offer the same level of automation of document distributions that investigatorFIRST offers. The core of investigatorFIRST is a graph-based taxonomy paired with a distribution engine that's designed specifically for clinical and safety document distributions. Constructs like Programs, Trials, Trial Sites, and their relationships are first class entities in investigatorFIRST but must be transposed onto first class entities in Box or Intralinks like folders and workspaces. Think of it this way: you can use a general purpose chef's knife to cut bread, but a bread knife is specifically engineered for the task of slicing bread cleanly and efficiently; Box and Intralinks are general purpose tools that you must conform to highly specialized clinical and safety workloads.
If you are already using Box or Intralinks, investigatorFIRST can layer on top of those repositories and automate distribution of files into targets in those repositories and workspaces. This reduces the manual effort and increases compliance by reducing the turnaround time and error rate.
investigatorFIRST also offers out-of-the-box reports which matter to your operational staff on a day-to-day basis as well as enterprise-wide metrics on acknowledgement rates, distribution rates, and other key data points.
Why should I consider InnovoCommerce over [fill-in-the-blank]?
We are the first and 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.
InnovoCommerce offers multiple modes of deployment to fit your budget and regulatory needs.
Technology is our advantage
Unlike traditional systems used for document exchange built on legacy hierarchical structures, investigatorFIRST is built on top of a highly connected graph database capable of modeling billions of nodes and relationships.
Our unique architecture and functional design minimizes duplication of documents to reduce the amount of storage you need to provision to support your global operations 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.
investigatorFIRST is designed from the ground up to meet the needs of the world's largest pharmaceutical companies at enterprise scale.
Pharmaceutical Community Benefits from Enhanced Security, Productivity, and Customer Experience IRVINE, CA – InnovoCommerce, makers of the only clinical and safety document exchange system deployed by multiple global pharmaceutical companies, today announces a partnership with Exostar, the leading provider of identity management solutions for the life sciences industry. The relationship brings the convenience and security […]
InnovoCommerce is exhibiting at DIA’s Conference on June 24-28 at the Boston Convention & Exhibition Center in Boston, MA. Stop by our booth to learn more about our cloud-based eClinical collaboration solutions for global clinical trials and compliance. Visit http://www.diaglobal.org/flagship/dia-2018 for more details.