Streamlining clinical trialsAle Gicqueau, president and chairman of  Clinovo, a clinical data solutions company, knows what it takes to make a clinical trial efficient from start to finish.
Here, Gicqueau talks about the many benefits of Clinovo like how its cost-effective solutions help clients save time and money throughout the entirety of the clinic trial process.
Talk about how Clinovo streamlines clinical trials. How is the Clinovo approach different?
Clinovo benefits from a unique technology expertise combined with a vast clinical trial experience, relying on a team of subject matter experts. Most of the time in our industry, service providers are either technology experts with limited understanding of the clinical trial process, or full-service CROs lagging behind on latest, cutting-edge technologies. We combine the best of the two.
We differ from our competitors thanks to our self-enabling vision. Our focus lies in empowering the users through easy-to-use, drag-and-drop tools. ClinCapture removes IT dependency and allows clinical trials experts to use ClinCapture’s self-service platform to build their CRFs, deploy their studies, and start entering their patient data themselves.
Our third key differentiator comes from our capacity of leveraging open-source to provide cost-efficient technologies. We offer the same advantages as traditional, proprietary, expensive solutions at a fraction of the cost.
What features or processes offered by Clinovo are most popular with clients? Why?
ClinCapture is Clinovo’s flagship product. ClinCapture is the only free validated electronic data capture software in the life science industry. With this product, users are now able to design, create and deploy their clinical studies without any programming experience. Our CRF designer Forms Studio is our most popular feature, as it enables our users to keep full control of their studies while significantly lowering their costs.
In the last decade, we have built a network of technological partners that can also integrate with our system through open APIs, which make our ClinCapture platform more than just an EDC system but a true eClinical hub.
Finally, our open-source roots influence the way we designed the product and kept growing a relevant community that directly contributes to our platform. By joining this community, our users can directly influence our EDC product roadmap and therefore help us improve the product they are using daily.
Explain ClinCapture and how it benefits clients.
ClinCapture benefits our clients in several ways. Our open-source core brings cost-effective solutions through collaborative code that easily integrates with complimentary systems.
The highly intuitive interface shortens the learning curve for sites, with streamlined data entry processes saving significant amounts of time and limiting the amount of errors.
Along with this, our CRF and edit check builders enable our customers to build their own studies in the Cloud in a matter of weeks without having to go through a costly and time-consuming IT setup.
How does Clinovo help clients save money?
Our free standard plan is one of the aspects with which our clients save money. In addition to giving advanced features such as Forms and Rules Studio to our customers as part of this free standard offer, Clinovo also extends this model to its hosting services. Clinovo is the only EDC player offering a fully validated 21 CFR part 11 compliant hosting environment free of charge. ClinCapture is also one of the only EDC systems to be WHOdrug certified and also to integrate a randomization module in its software.
The do-it-yourself tools featured in the EDC system prevent clients from requiring additional professional services, often cost-prohibitive for smaller companies. In addition to this, our streamlined clinical data entry process allows our clients to save significant amounts of labor time.
What are some advantages of using Clinovo services versus in-house clinical trial management?
Clinovo is proponent of empowering our clients to do the work themselves, by removing any upfront cost and making the build process extremely simple, therefore eliminating any barrier to entries.
However, Clinovo is a trusted, reliable partner to outsource the work instead of doing it in-house. Clinovo acts as an extended team when the sponsor company lacks the bandwidth to build its databases. Clinovo has a local team as well as a large network of Contract Research Organizations (CROs) very well versed with the ClinCapture platform, which can build databases in a very fast manner. Also, Clinovo is able to perform clinical data management and biostatistics, which require a very specific, unique skillset, not always available for smaller companies.
What trends are happening currently with data capture? What trends are happening in other arenas relevant to clinical trial planning?
The Electronic Data Capture industry is currently experiencing some major changes. EDC is clearly becoming a commodity; more and more companies are moving away from paper-based clinical studies to scaled EDC systems.
Along with that, the Cloud environment has obviously disrupted the market. End users are now able to access their studies from anywhere at any time. The increase in the management of higher amounts of data is very challenging for life science companies that use data capture.
In parallel, the EDC products themselves are evolving. Life science companies aim at building adaptive clinical trials along with risk-based monitoring. This is why more and more EDC companies are trying to provide eClinical software integration along with their standard offer to fit with the customers’ requirements.
Why is it challenging to integrate patient data from EMRs, and how does Clinovo handle this?
Integrating patient data from Electronic Medical Records is a very challenging task for numerous reasons. Physician practices, for example, have a very low adoption rate when it comes to EMRs. The biggest problem, however, comes from the interoperability between EMR and EDC. The tools provided from vendors to extract data from EMRs are clearly lacking.
Moreover, the lack of standardized payload and method of delivering from different EMRs to the EDC systems enhances that issue. It is therefore very difficult to deal with clinical study subjects that aren’t part of the same health system and, therefore, the same EMR.
Once that step is overcome, a deficiency sustains in the methods for identifying the same patient in between EMR and EDC systems without even mentioning the inability to map and translate some EMR data sets into case report forms (CRF) of the EDC systems.
These challenges are definitely worth taking into account, but the costs of duplicate entry and the associated errors are higher than the costs of establishing the interfaces to the external systems. We, at Clinovo, are definitely interested in the use cases of the industry players and welcome any dialogue or feedback on this very exciting challenge.
How has technology helped change the world of clinical trials and the collection of medical data?
The world of clinical trials has been through several intense turnovers during the past decade. One of the main improvements concerns the collection of medical data. With the technologies used today, the data quality has definitely been ameliorated. Edit checks and controls are now able to spot mistakes earlier in the process and also at a larger scale than ever before.
Technology also improved the safety level by allowing manipulation and analysis of significantly larger amounts of datapoints. Computational predictive analyses help the industry players to refine patient candidacy as well as patient safety.
The application of new generation clinical trials analytics, such as visual, self-service, and interactive dashboards, will improve the overall operation of clinical trials. These tools not only advance retroactive tracking of results, but further enable proactive decision-making by spotting patient safety issues earlier and faster.
In addition to this, Cloud technologies have drastically changed the way smaller companies address innovative science and patient treatment by allowing access to advanced and sophisticated solutions (higher quality of data and therefore higher FDA success rate) that were only accessible to the large pharmaceutical companies in the past.
Please share anything else you would like to say about Clinovo.
Clinovo will be holding an Online Demonstration of our ClinCapture Builder on March 26th at 10:00am PST. This demonstration will showcase how to use our intuitive drag and drop CRF builder to build and deploy your study faster as well as how to add any number of complex edit checks to your CRFs. With our new ClinCapture builder, clinical trial professionals can create their study in minutes, build and deploy their CRFs in a matter of days, and manage all their studies from one central location. Register Here. We’re looking forward to seeing you there!
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Last Updated on March 14, 2015