How can we help you?

The study sponsor isn’t allowed to see any identifying patient data – how does Climedo deal with this?

Climedo offers the possibility to define granular and role based access controls. This includes the option to prevent specific users (like sponsors) from accessing identifying patient data.

Does the Climedo system work with firewalls?

Climedo is a web-based application, and in most environments will not be affected by local firewalls. If you are concerned about Climedo's compatibility with your local firewall, please contact the Climedo Support team at info@climedo.de.  

How are data protection and privacy implemented and where is the data hosted?

Climedo is a cloud-based system which uses server suppliers with all servers based in Frankfurt, Germany. All servers are ISO-certified, and databases are saved on multiple separate servers. Climedo is GDPR-compliant and has been penetration-tested by multiple private companies and IT security authorities (BSI) of the German Federal Government. All data is hosted in a cloud. Different study centers and monitors can access the same study. Our databases (patients, studies) are hosted on different servers. These are all located separately in Frankfurt am Main. Our data protection concept is GXP and GDPR compliant.

How does Climedo ensure the security of its solutions?

Security is of utmost importance at Climedo Health. Climedo's AWS servers are officially certified in the field of Information Security (ISO 27001 – Standards for Information Security Assurance), the standard that describes how Information Security should be organised in a process-based manner in the context of the general business risks for the organization. Besides using only servers in highly certified security data centers, Climedo implements a strategy of strong data separation, state-of-the-art encryption schemes accompanied by company-wide standard operating procedures that allow us to provide a level of data privacy and data security that complies not only with our own high standards in terms of data integrity, availability and confidentiality, but of course also all legal as well as ethical requisites.

What assistance does Climedo offer with regard to the EU MDR (Medical Device Regulation)?

Together with our external consulting partners, we offer one-day and multi-day workshops on topics such as EU MDR, incentivizing product users, PMS and PMCF, etc. Our target groups are Regulatory Affairs and Clinical Affairs managers of manufacturers as well as product users and Key Opinion Leaders (KOL). You can find free downloads about the EU MDR here.

What's the difference between a product study and medical study?

A medical study would be a pharmaceutical study, for example. For a product study, you need to have entered a specific product into the system's study registry.

Can Climedo also be used for clinical evaluations and what is the difference between clinical studies and surveys?

Clinical evaluation is carried out as part of PMS and is the overarching term. Not every clinical evaluation requires a study or survey. Climedo would then be a part of the clinical evaluation.

What advantages does Climedo Health offer companies?

Our customers praise the simple and intuitive user interface, which helps to reduce the workload of physicians and to involve them more closely. All collected data can be viewed at the push of a button Climedo is certified according to the highest data protection and security standards; all data is hosted in Germany.

What does Climedo Health offer?

Climedo offers an EDC (Electronic Data Capture) which facilitates clinical data capture as part of studies and PMS / PMCF activities and connects all those involved (doctors, patients, manufacturers) via a common platform.

Is customer support included in the costs?

Our customer support is available by phone and email during normal business hours. Depending on your support needs, there are different packages (bronze, silver and gold) – please get in touch with us for more information.

Is there a set-up fee for the instance?

Yes, there is usually a one-time fee for setting up the Climedo instance which depends on the scope of service.

Are there costs for each project?

Yes, but there are also package prices. For an individual pricing quote, get in touch with our team!

Is there a minimum contract duration and what are the payment and cancellation periods?

Normally the minimum contract duration is one year; however, we can offer an initial short pilot project for testing before the annual contract starts. Payment takes place yearly in advance. Cancellation is possible three months before the end of the contract.

Are the questionnaires related to the costs?

No, you can include any number of questionnaires per survey. This does not affect the overall costs.

Is it necessary to purchase a single license for each user?

No, it is not necessary to purchase a single license for each software user. You only pay per study or survey and can have any number of licenses and users in the system.

How much does it cost to use Climedo?

For each project, we charge a monthly SaaS fee and a one-time set-up fee. You will pay per active study or survey and per month, with as many users as you like. For further details, please visit our Pricing and Packages.

What kind of knowledge base does Climedo offer within its software?

As part of our knowledge base, we offer an interactive user guiding tool to dynamically guide the user through the software, eLearning materials, help videos and a regular product newsletter about new features.

How long does it take to learn Climedo's software?

In most cases, it takes about three to five hours to become familiar with Climedo's solutions and to be able to set up initial studies or surveys independently.

Which computer skills are required in order to use Climedo?

To use Climedo's software solutions, only basic computer skills are required, such as the use of an internet browser. No programming knowledge is needed whatsoever.

Can we also answer questions about the product without contacting customer support directly?

Yes, thanks to our detailed manual and our eLearning materials (such as manuals, user guiding and videos), many questions can be answered independently of our customer support.

What support does Climedo provide for changes or user requests (e.g. access data management)?

For any questions related to changes or user requests, users can contact us via email at any time. It is possible to get a "full-service" support or even a "self-service" use. Our first level support is also offered for study centers.

What support does Climedo provide for onboarding?

As part of its support services, Climedo offers web demos with training character. These usually take place three to five times, depending on how many different user groups are involved.

How is Climedo validated?

The Climedo system is audited according to relevant standards and guidelines such as ICH GCP, GAMP5, FDA 21 CFR Part 11 and EU GMP Annex 11. Our software development process follows an agile implementation of the V-model and the GAMP5 guidelines and is validated afterwards. Our SOPs are audited by external auditors and found to be good. Validations of individual projects are carried out through User Acceptance Tests (UATs). These tests are performed together with the customer and are accepted by the customer. Climedo had the last vendor audit in 2019 for a customer in the pharmaceutical industry that confirmed this.

Is Climedo a validated system?

Yes, we have followed the GAMP5 standards for the validation of the Climedo system to the best of our knowledge. The software supports our clients in getting compliant with FDA 21 CFR Part 11, Good Clinical Practice (IHC-GCP) and EU-GMP Annex 11.

Is Climedo compliant with 21 CFR Part 11?

Climedo was successfully audited according to 21 CFR Part 11 in 2019 and other standards.