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Privacy Policy

 

1. An overview of data protection

General

The following gives a simple overview of what happens to your personal information when you visit our website. Personal information is any data with which you could be personally identified. Detailed information on the subject of data protection can be found in our privacy policy found below.

Data collection on our website

Who is responsible for the data collection on this website?

The data collected on this website are processed by the website operator. The operator's contact details can be found in the website's required legal notice.

How do we collect your data?

Some data are collected when you provide it to us. This could, for example, be data you enter on a contact form.

Other data are collected automatically by our IT systems when you visit the website. These data are primarily technical data such as the browser and operating system you are using or when you accessed the page. These data are collected automatically as soon as you enter our website.

What do we use your data for?

Part of the data is collected to ensure the proper functioning of the website. Other data can be used to analyze how visitors use the site.

What rights do you have regarding your data?

You always have the right to request information about your stored data, its origin, its recipients, and the purpose of its collection at no charge. You also have the right to request that it be corrected, blocked, or deleted. You can contact us at any time using the address given in the legal notice if you have further questions about the issue of privacy and data protection. You may also, of course, file a complaint with the competent regulatory authorities.

2. General information and mandatory information

Data protection

The operators of this website take the protection of your personal data very seriously. We treat your personal data as confidential and in accordance with the statutory data protection regulations and this privacy policy.

If you use this website, various pieces of personal data will be collected. Personal information is any data with which you could be personally identified. This privacy policy explains what information we collect and what we use it for. It also explains how and for what purpose this happens.

Please note that data transmitted via the internet (e.g. via email communication) may be subject to security breaches. Complete protection of your data from third-party access is not possible.

Notice concerning the party responsible for this website

The party responsible for processing data on this website is:

CRI GmbH
Arnulfstraße 19
80335 Munich

Directors: Elisabeth Freund, Dr. Thomas Fetsch

Telephone: +49 89 9901649-0
Email: info@cri-muc.de

The responsible party is the natural or legal person who alone or jointly with others decides on the purposes and means of processing personal data (names, email addresses, etc.).

Revocation of your consent to the processing of your data

Many data processing operations are only possible with your express consent. You may revoke your consent at any time with future effect. An informal email making this request is sufficient. The data processed before we receive your request may still be legally processed.

Right to file complaints with regulatory authorities

If there has been a breach of data protection legislation, the person affected may file a complaint with the competent regulatory authorities. The competent regulatory authority for matters related to data protection legislation is the data protection officer of the German state in which our company is headquartered. A list of data protection officers and their contact details can be found at the following link: https://www.bfdi.bund.de/DE/Infothek/Anschriften_Links/anschriften_links-node.html.


Right to data portability

You have the right to have data which we process based on your consent or in fulfillment of a contract automatically delivered to yourself or to a third party in a standard, machine-readable format. If you require the direct transfer of data to another responsible party, this will only be done to the extent technically feasible.

SSL or TLS encryption

This site uses SSL or TLS encryption for security reasons and for the protection of the transmission of confidential content, such as the inquiries you send to us as the site operator. You can recognize an encrypted connection in your browser's address line when it changes from "http://" to "https://" and the lock icon is displayed in your browser's address bar.

If SSL or TLS encryption is activated, the data you transfer to us cannot be read by third parties.

Information, blocking, deletion

As permitted by law, you have the right to be provided at any time with information free of charge about any of your personal data that is stored as well as its origin, the recipient and the purpose for which it has been processed. You also have the right to have this data corrected, blocked or deleted. You can contact us at any time using the address given in our legal notice if you have further questions on the topic of personal data.

Opposition to promotional emails

We hereby expressly prohibit the use of contact data published in the context of website legal notice requirements with regard to sending promotional and informational materials not expressly requested. The website operator reserves the right to take specific legal action if unsolicited advertising material, such as email spam, is received.

3. Data protection officer

Statutory data protection officer

We have appointed a data protection officer for our company.

Jochen Lutz, Radix GmbH, Lerchenauer Str. 277, 80995 Munich

Telephone: +49 89 990 1649 771
Email: dataprotection@cri-muc.eu

4. Data collection on our website

Cookies

Some of our web pages use cookies. Cookies do not harm your computer and do not contain any viruses. Cookies help make our website more user-friendly, efficient, and secure. Cookies are small text files that are stored on your computer and saved by your browser.

Most of the cookies we use are so-called "session cookies." They are automatically deleted after your visit. Other cookies remain in your device's memory until you delete them. These cookies make it possible to recognize your browser when you next visit the site.

You can configure your browser to inform you about the use of cookies so that you can decide on a case-by-case basis whether to accept or reject a cookie. Alternatively, your browser can be configured to automatically accept cookies under certain conditions or to always reject them, or to automatically delete cookies when closing your browser. Disabling cookies may limit the functionality of this website.

Cookies which are necessary to allow electronic communications or to provide certain functions you wish to use (such as the shopping cart) are stored pursuant to Art. 6 paragraph 1, letter f of DSGVO. The website operator has a legitimate interest in the storage of cookies to ensure an optimized service provided free of technical errors. If other cookies (such as those used to analyze your surfing behavior) are also stored, they will be treated separately in this privacy policy.

Server log files

The website provider automatically collects and stores information that your browser automatically transmits to us in "server log files". These are:

·       Browser type and browser version

·       Operating system used

·       Referrer URL

·       Host name of the accessing computer

·       Time of the server request

·       IP address

 

These data will not be combined with data from other sources.

The basis for data processing is Art. 6 (1) (f) DSGVO, which allows the processing of data to fulfill a contract or for measures preliminary to a contract.

5. Plugins and tools

Google Maps

This site uses the Google Maps map service via an API. It is operated by Google Inc., 1600 Amphitheatre Parkway, Mountain View, CA 94043, USA.

To use Google Maps, it is necessary to save your IP address. This information is generally transmitted to a Google server in the USA and stored there. The provider of this site has no influence on this data transfer.

The use of Google Maps is in the interest of making our website appealing and to facilitate the location of places specified by us on the website. This constitutes a justified interest pursuant to Art. 6 (1) (f) DSGVO.

Further information about handling user data, can be found in the data protection declaration of Google at https://www.google.de/intl/de/policies/privacy/.

 

Use of jQuery

Our website uses the javascript library jQuery, which optimizes loading speeds. In this respect, program libraries are accessed from Google servers and the CDN (Content delivery network) is used by Google. If you previously used jQuery on another page of the Google CDN, your browser will revert to the cached copy. If this is not the case, downloading is required, whereby data is sent from your browser to Google!Inc. "("Google"). Your data will be transferred to the USA. You can find out more under: https://developers.google.com/speed/libraries/#jquery as well as under the data protection regulations of google.de.

 

Source: eRecht24

 

 

news-arrowNews
NOAH – AFNET 6 Study has started

Another big trial, the NOAH – AFNET 6 study, sponsored by the non-profit research network AFNET e.V. has started. By the end of June the first patient has been included. In total 3400 patients will be enrolled into this international phase IIIb study in about 230 sites in 15 European countries.

The main purpose of the NOAH - AFNET 6 study is to demonstrate that oral anticoagulation with the NOAC edoxaban is superior to current therapy (antiplatelet therapy or no therapy depending on cardiovascular risk) to prevent stroke, systemic embolism, or cardiovascular death in patients with atrial high rate episodes (=AHRE) but without atrial fibrillation and at least two stroke risk factors.

CRI is the full service lead CRO for this project and will provide all necessary services ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes also all regulatory issues, handling of contracts, data management services as well as monitoring, safety and site reimbursement.

19.06.2015 – Enrolment of the 2000th patient for EAST

By mid-June the 2000th patient has been enrolled in the EAST – AFNET 4 trial. The investigator initiated clinical trial ‘Early treatment of atrial fibrillation for stoke prevention trial’ (EAST) is currently conducted in 11 European countries with more than 100 participating study sites and compares to different therapeutic strategies for the treatment of atrial fibrillation. The trial investigates whether the course of disease of patients with recently diagnosed atrial fibrillation can be influenced in a positive manner due to early rhythm control therapy in comparison to usual care therapy. Controlled clinical trials published to date could not provide evidence that patients benefit from an early rhythm control therapy whereby rhythm control measures were applied quite late.

April 2015 SERVE-HF Study

SERVE-HF study: follow up was completed successful in April 2015. Now the final assessment period is ongoing. Firs results of preliminary analyses are available. Please visit: http://www.resmed.com/servehffaqs/index.html

01.03.2015 AXAFA-AFNET 5 Study started

International phase IV trial on the topic of catheter ablation of atrial fibrillation and anticoagulation with NOACs. About 60 study sites in Europe and the Unites States will include and follow up on about 630 Patients until mid-2017. Sponsor is the non-profit research network AFNET e.V.

CRI is the full service lead CRO for this project and will provide all necessary services in cooperation with an US based partner CRO, ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes handling of contracts, data management services as well as monitoring, safety and site reimbursement.

http://www.kompetenznetz-vorhofflimmern.de/en/axafa-trial-examines-noac-apixaban-during-af-catheter-ablation

June 2014: SERVE-HF „Major Substudy“ ends one year after end of recruitment

Slightly over a year after the end of recruitment for the SERVE-HF study the data collection for the “Major Substudy” (Substudy on the mechanistic plausibility of the clinical benefits of adaptive servo-ventilation) has come to a close. The required number of follow-ups with the accompanying imaging techniques has even been surpassed by far. The follow up of all patients in SERVE-HF will continue until mid-2015 and analysis of the data will have to wait until after this time point. First published results are expected in the fall of 2015.

25.04.2014 Start of Clinical register to rare microangiopathy (CESAR)

Rare diseases can generally only be detected and observed in larger clinical registers. This also applies to the diagnosis of rare thrombotic microangiopathies. The goal of this epidemiological study is to find out the frequency with which bacterial infections or bleeding disorders are the cause and whether other clinical factors may be of aid for the differential diagnosis. We expect to document about 300 patients until April 2016.

24.01.2014 Start of Europe-wide clinical registers for portable defibrillator vest (WCD) (WEARIT II Europe)

It is being studied under regular treatment conditions, whether the WCD may temporarily protect potentially vulnerable patients. This is, for example, necessary after acute myocardial infarction when the pumping function of the heart is severely limited and, consequently, life-threatening cardiac arrhythmias can occur. On the other hand, the spontaneous recovery of heart failure is possible.The register 700 patients will be documented and tracked until January 2017.

CRI is the full service lead CRO for this project and will provide all necessary services, ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes handling of contracts, data management services as well as monitoring, safety and site reimbursement.

04.11.2013 – 1000. Patient randomised for EAST

In the beginning of November 2013 the 1000. patient was randomised in the AFNET-EAST trial. The EAST study („Early treatment of atrial fibrillation for stroke prevention trial”) is ongoing in 11 European countries and compares two different therapeutic strategies for atrial fibrillation.

EAST demonstrates that independent, investigator initiated studies are essential to gain scientifically relevant knowledge in the clinical research.

Many issues of medical treatment like those studied in EAST would not be investigated in commercial trials.

Again the team of CRI demonstrates its great expertise in design, set-up and  implementation of international “Investigator-Initiated-Trials” (IITs).

31.05.2013 –international SERVE-HF reaches recruitment target

Recruitment for the study “Treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive servoventilation in patients with heart failure” (SERVE-HF)” was completed on 31.05.2013.

The follow-up period for the 1.325 randomized patients from 10 European countries will be two years.

The CRI Team has mastered the challenge to coordinate two different medical fields (sleep medicine and cardiology) in a parallel randomized trial despite many procedural and logistical challenges.

Experts eagerly await the result of the study.

18.02.2013 - EAST

Today the 600 patient is included in our EAST study. The study is already running in 8 European countries.

26.04.2012 – 1,000th patient in SERVE-HF

Today, the 1000th patient was included into our SERVE-HF study. This controlled clinical endpoint study aims to find out whether patients with central sleep apnea and associated heart failure benefit from a adaptive servo ventilation at home in the long term. Approx. 250 study sites in 9 European countries and Australia are participating in SERVE-HF. 

CRI is the full-service lead CRO and has partnered with an Australian CRO to provide all required services to the project; these include the design of the study protocol and e-CRFs, all regulatory proceedings, management of contracts with study centers and other involved parties, project- and data management as well as monitoring, safety, handling of fees and production of the final report

20.03.2012 - Second GCP audit

Another major international study project in which CRI acts as a full service CRO, was audited on behalf of the sponsor. Objective of the audit was to assess whether the established processes  comply with the requirements of ICH GCP and applicable legal requirements. We are pleased with the positive evaluation  and the progress of the study.

24. – 27.01.2012 – First GCP audit

Just under 10 months after the opening of the institute, CRI has passed its first GCP audit well. A large international sponsor engaged an independent auditor to evaluate their CRI-conducted project, as well as all relevant procedures at CRI – there was no major complaint. We are pleased with this outcome and feel encouraged to continue on our way.

01.09.2011 – CRI moves into its new office in the Renaissance House in Munich

After a long search and extensive alterations, CRI has now moved into its new office. The Renaissance House offers a pleasant surrounding combined with modern infrastructure – and excellent connections to the Central Railway Station as well as all to city trains (“S-Bahnen”). Located on the 5th floor, we enjoy an unrestricted view over much of Munich and look straight at the Alps – a panoramic vista that clears the mind for innovative tasks.

28.07.2011 - FPI in EAST

With the participation of 200 study sites across 11 countries, this controlled clinical endpoint study aims to find out, wether patients with atrial fibrillation will benefit from an early rhythm-sustraining treatment in the long term.

Sponsor is the non-profit research network AFNET e.V.
CRI is the full service lead CRO for this project and will provide all necessary services, ranging from the preparation of the study protocol and eCRF to the completion of the final report; this includes handling of contracts, data management services as well as monitoring, safety and site reimbursement.

01.04.2011 – CRI starts its activities at the Regus Business Cente

The Clinical Research Institute with its initially small team has started its operations. The first project contracts have been signed or will be signed soon. To ensure that the Institute will be able to conduct international projects comprehensively and according to industry standards in the near future, it is planned to rapidly grow the CRI team.