cvSENTINEL

Live outcome data from medical records
1

WHAT

The ClinHEOR Software-as-a-Service is an application for the pseudonymised or anonymised collection and centralisation of datasets from local databases of universities, clinical centres and practicing physicians (e.g. practices, MVZs or practicing physicians with medical information systems) for feeding in real time, live outcome studies and for answering scientific questions from health services research.

The advantage of data recognition in datasets lies in answering your research questions in real time while complying with German data protection laws. Based on a data description, our cvSentinel searches out the data from the local system and offers a description of this data to the server. As soon as the patient's case-related declaration of consent is available, this data can be transferred within a study, for example. The transfer saves time and avoids transmission errors.

Depending on the question, one-time anonymous evaluations or pseudonymous long-time histories can be documented.

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HOW

A list of the data categories searched for can be deposited with the ClinHEOR service. cvSentinel downloads the data specific to this description to the local system, identifies local records, collects and clusters them and synchronises the meta-information with our main database. Changes to the local data, known as the delta, can be reconciled by the local system with the central database at specified times.

The transmission of the delta follows the principle of data economy, so that the data sets to be transmitted remain small.

All connections are encrypted and cryptographically secured. Data can only be merged after the keys and the cryptographic algorithm have been successfully checked.

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WHY

Live data is essential for a growing number of scientific questions about patient treatment and medication. cvSentinel, with its central database ClinHEOR, provides results from source data for studies to provide the basis for answering these questions. Our service is conducted in full compliance with data security regulations and under the protection of independent ethics committees, while fully respecting individual privacy. If the medical data in itself could be used to draw conclusions about individuals, this data will not be used.

Especially against the backdrop of demographic change, secure technologies for the transfer of data and their integration into existing systems in medicine are increasingly coming into the focus of scientists.

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Facilitating / Usability Functions

Sentinel:

Handling all of the data collected by the Clinovate Sentinel can be overwhelming. With this in mind, we developed the user interface to allow easy selection and viewing of data which is of relevance to your hypothesis and study. In addition to this, the data you select is visually summarized, facilitating a quick overview of data comparison, or trend monitoring.

Data Export

Any format you may require:

Data can be export from our system to be used for statistical analysis and review. How you would like this data is entirely up to you – and we offer a wide variety of formats to export it to help meet your needs of data analysis. In assisting you to accomplish this, we can export the data not only in various formats, but also have it pre-segregated according to parameters such as centres, patient variables, or any other reasonable request.

Customizable Data Colections

You set the parameters; we present you with the data:

Sifting through the big amount of demographic and clinical data collected from everyday clinical practice is time-consuming. Clinovate streamlines this process by providing you with an array of filters and customizable parameters which permit you to fine-tune the sample you require for your study. Say you require data regarding the use of a particular medication within a particular demographic of patients – same as if you were to run a clinical trial. Data from a specific patient demographic can be requested according to parameters you set out, such as medication, diagnosis, gender, location - any clinical or demographic feature. The data is collected by our sentinel from all participating clinical practices, and is processed within our database to ensure we adhere to strict data privacy policies – no personal or identifiable information is exchanged in the process. Once processed, you receive your initial dataset. We say initial, as our sentinel further processes the ‘delta’ of the readout – meaning you receive all updates from existing patients, as well as the addition of any new patients. These updates happen nightly - with changes ready for you the next day. There is a variety of datasets you can receive, be it from a single readout of data from a time point, or a regularly updated dataset which you can use in the real-time review of data. We do this, whilst adhering to strict data privacy policies, assuring that the personal information of individuals is always adequately protected.

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Unobtrusive Processing

Data collection, without the additional input:

For out participating private practices, sentinel service collects data without interfering with your daily work. There are no additional forms to fill out, not data requests, not even pop-ups or confirmations that the data is being read out. Our sentinel is an add-on service to your existing clinical management software. We do not collect all of the data from your servers or database – instead, the way our process functions by reviewing existing and new data requests from researchers, and forwarding these requests to our Sentinel. cvSentinel merely reviews the data you have within your database and reads out the data which ticks all of the boxes of the data requests. In addition to this, cvSentinel also reviews the changes (or delta) of the existing request and updates users with real-time data from your private practice or clinic.

Automatic Unit Conversions

Output to any unit you require:

Various institutes and users will input data into their system in accordance with their daily practice. From one clinic to another, these vary. We have addressed this by assuring that all data is converted into a universal unit – which can further be exported into whichever unit you may require for your needs. The automatic conversion of units serves as a further feature in our unobtrusive processing, as no changes are required in the normal daily input of clinical data. It is irrelevant for us if you use ml/l instead of PMM, or pmol/L instead of ng/dL. Our automatic data conversion converts data into the required unit in the desired output. In doing this, we ease the use of data requested on the receiving end of cvSentinel – allowing for your research to be conducted without any additional conversion tools for lab results from any number of labs using any variety of units.

Job Definitions

Job Planner Module:

All necessary jobs done by sentinel software can be precisely planned. This precise planning assures that jobs do not interfere with any other critical system services – cvSentinel operates as a separate entity in clinical management and data collection. All of the functions of the sentinel, including gathering data, integration, transport, and the daily reporting service, are all defined and customized with every job – these definitions are required only once, and no further input is needed to have complete functionality of cvSentinel.

Mail Functions

Real time updates, sent to you:

As sentinel collects data in real time, we can provide real-time notifications regarding the data. This can be when a particular value is reached within the cohort, or when a particular number of patients have been achieved. All of these functions can be opted-in, or opted-out on your administrative page – you choose which information is relevant to you.

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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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.

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EDC

cvEDC - At your fingertips!

Clinovate NET's cvEDC (Electronic Data Capture) is a web application for capturing and managing clinical data for all research needs of your various interventional and non-interventional trials.

Our solution is fully customisable to your needs and provides a user-friendly, browser-based, responsive interface to easily and securely document, protect and process your data. While remaining highly flexible, we adhere to FDA CFR Part 11 and GCP guidelines. We adapt the visual and functional design to your needs to give you optimal results.

We offer you all services from the entire value chain until the completion of your clinical trials. At any point in time, you decide where you want to involve us and let us do the work for you.

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