cvEDC

Electronic Data Capture web application
1

Easy

The Clinovate Electronic Data Capture Application is an easy-to-use electronic platform to run studies and clinical trials. You can combine it effortlessly with other tools to have your study online fast and equipped with widespread functionality that assures data validity.

cvEDC makes all the difference, as it is built and designed to meet the needs of medical personnel. Because it is completely built on the CDISC ODM Model, the data sets can be imported and exported very easily.

With our intuitive form creation tool, you can easily create the study process with all events and all forms online together as a team. Extensive data import and export options make it easy for you to reuse study templates that have already been created.

2

Assured

We work within the confines of ISO9001 and ISO27001 requirements, and meet the stringent technical requirements of the FDA 21 CRF Part 11 and ICH GCP (Good Clinical Practice).

Our products collect audit trails of electronic data, signing of data, the reason for changes, rights and role management. All cvEDC trials come with a test-driven life cycle management creation process, which includes a thorough risk management protocol.

Each step and every change request undergoes a documented test-driven process in a test surrounding. After positive testing, the changes are transferred to the production environment following stringent testing.

3

Responsive

All Clinovate products are developed in a way to assure the best possible user experience. We primarily achieve this because we know our peer group perfectly - as we are part of this group. Secondly, we are making the platform accessible and usable from any device as long as it has browser access and an internet connection.

Forms and workflows within our software are also tested towards a logical set-up to ensure simple access to requested data and information.

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cvEDC features

Our edc comes with a wide range of functions out of the box. Every trial is equipped with a dashboard that keeps you updated throughout the running phase of your trail. Standard reports help you to keep track with developments. Automated Pharmacovigilance reports collects data and helps to report incidents save and fast.

Study & Form designer

Create your study design, all workflows, rules and forms with our intuitve online tool. You can control the whole process yourself. We help, where every you need a hand. Extensive options for importing and exporting data sets help you to use existing code lists, variables or translations.

ODM Compatible

An ODM (Operational Data Module) is a clinical data management system standard. This forms the baseline of our Case Report Forms (CRFs). Where there are large capacities of heterogeneous, linked data the CDISC ODM data model forms the scaffolding required to initially capture, and subsequently and re-use data. Data saved in this format can be integrated into our system from existing trials, as well as forwarded into other systems of data capture, where necessary.

Tailored Design

Assuring the visual identity of your EDC:

As every trial is unique, so is the interface which it is built upon. From the visits, questions, forms, layout and even colour scheme, all of the features of cvEDC are entirely customizable. Even after the interface is in production, users can move around features in which suit them best, according to their needs. We assure that users have the best possible experience in managing their clinical data.

Monitoring

Our EDC system offers you extensive monitoring options for verifying the source data. No matter if you want to check samples or 100%.

Target Data Views

See the trees from the forest!

Data from clinical trials is extensive, with the inclusion of demographic data, clinical history, and trial outcomes present for every patient – in trials which can contain thousands of patients. We strive to make all of this data as clear and searchable as possible. Patients can be assorted according to any variable which might define them, including multiple factor searches – giving view only to a specific demographic which may be of interest to you and your research. Additionally, all of our trial events, forms and queries are also based on intuitive designs and patterns which make sense in the context of immense data capture.

Input / Output

cvEDC is capable of incorporating any data you may be carrying across from a previous trial, or from your clinic. Data can be input quickly from any of the standard formats of clinical data management (such as CVS and excel formats) All of the data which is input into the trial can be exported into a variety of formats for your research requirements, including all standards, such as CSV and Excel, as well as software specific formats for SPSS and STATA.

External Resources

External, regularly updated lists from well known sources:

A feature we provide within our system is the possibility of integrating existing clinical terminology databases to support the collection of trial data. Lots of medical issues – such as comorbidities of patients in your trial – can come from well-known and regularly maintained databases, such as ICD 10. Drugs and concomitant medications can come from MedDRA or Rote Liste. We aim to improve the quality of data collected, whilst making it easier for participating centres to input the correct variables where required. Therefore all of the data in these databases is searchable and indexed – and can autocomplete.

Responsivness

cvEDC is entirely browser-based and can be viewed on any device with a browser. There is no installation required, no administrative access necessary for the use of cvEDC on network computers - just log in and work. The interface is responsive and works in a way which assures maximum readability and usability on any device – irrelevant of the screen size.

Feasibility
Feasibility

cvFeasibility - Increase success!

Use cvFEASIBILITY to choose the best fits for your clinical trail, save time and effort to significantly increase the output of your project.

Our application enables CROs and Sponsors to create feasibility studies that automate all the steps of bringing information together.

Set your inclusion criteria for participating and performing centres prior to contracting and onboarding, saving your project time-consuming and costly recruiter downtime and the occurrence of incomplete documentation.

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Sentinel

cvSentinel - Save time and effort!

ClinHEOR is our data plattform for cvSentinel, a description data-driven collection server-client solution, that automatically transfers defined data sets of study patients from local medical documentations to our central system.

Source data with different data type, content, scope or unit are automatically prepared in such a way that they are comparable and usable for statistics within the study. These data types can be medicines (coded by the PZN pharmaceutical central number), diagnoses (coded by ICD-10 codes), laboratory values and others.

The software meets the requirements of patient data security, FDA regulations and Good Clinical Practice rules and works with the latest security features to protect data synchronisation and access. The data can be used within our cvEDC.

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Identity

cvIdentity - Have control!

Our cvIdentity Server is a solution for managing user roles, rights and access for web applications. It provides a web portal and programmable API to manage these configurations. Management within a system provides complete visibility and customisation of user functions and access, with each user function customised accordingly.

Each registration process is clearly and simply structured, with step-by-step instructions to guide the new user through the process and make onboarding easy. Users can be members of different studies and projects, in different roles and with different rights.

With cvIdentity, your team members can supervise studies, plan a new study, perform feasibilties and chat and share documents with the whole team.

About Us

Clinovate NET™ ®
is a medical IT Company run by medical doctors and programmers to combine medicine and IT.

We offer web appliactions for medical trials, feasibility studies, live outcame data and idenitity mangement.

Contact

Pettenkoferstr. 30, Ground Floor
Munich, 80336

(+49) 89 59997474
(+49) 700 CLINOVATE