Marion Wendt

I completed additional training as a Clinical Research Associate in 1993 and the gained hands-on experience with a CRO and sponsor.
Since June 1997 I work as a freelance Senior Clinical Research Associate.

Through my involvement in several multicentre and multinational pharmaceutical studies (phases I-IV) as well as post–marketing studies within the therapeutic areas AIDS, Allergology, Cardiology, Dermatology, Diabetology, Endocrinology, Gastroenterology, Gynaecology, Hyperhidrosis, Immunology, Infectious diseases, Neurology, Nutrition, Obesity, Oncology, Ophthalmology, Orthopedy, Pain, Pneumonology, Psychiatry, Reproduction and Transplantation I am familiar with independent work “around clinical trials”.
Clinical trials of medical devices are also part of my experience.

I have fluent English and I am used to being flexible at home country and abroad. Working inhouse at sponsor is also a welcome assignment.

For further and detailed information about me please contact me directly. I will gladly provide you with further documents.

 I offer you the following activities:

• Budget planning and tracking
• Review protocol versus CRF as well as CRF creation
• Creation of patient information and informed consent
• Creation of study-specific documents
• Investigator recruitment
• Selection of trial sites
• Site qualification visits
• Support in ethics submission
• Notification of investigational sites to the competent authorities
• Conduct site initiations
• Monitoring (on-site and remote)
• Co-Monitoring and QC Co-Monitoring
• Coaching as well as mentoring of trial sites and CRAs
• Site closure visits
• Project Management
• Query resolution
• Trial Master File review at sponsor
• Organizing and realisation of investigator meetings
• Preparation of audits/inspections as well as participation and follow-up

 … and much more.

I conduct my activities according to the applicable regulations and recommendations (such as AMG, GCP Regulation, ICH GCP, MPG and ISO 14155) as well as the SOP`s of my clients.

Please contact me at cra@marionwendt.de or click contact,so that together we can discuss and plan your personal needs.

Responsible for the operation of this website

Marion Wendt
Senior CRA
Fichtenweg 22 a
46446 Emmerich am Rhein, Germany
Phone +49 (0) 2822 977417
Fax +49 (0) 2822 977418
E-Mail cra@marionwendt.de

VAT Reg No

DE187743741

Design

FIRMAZWEI GmbH

Dispute Settlement

For out-of-court settlement of consumer disputes, the European Union has set up an online platform ("OS platform") to contact. The platform can be found at https://ec.europa.eu/consumers/odr/.

Liability Notice

Despite careful compilation of the information prepared for this site, we grant no liability for its completeness and/or accuracy.
We have no influence on the content of third party offers, to which marionwendt.de may link and grant no liability.

Linkdisclaimer

This website may contain links to third party websites ("external links"). When connecting the external links for the first time, we check the external content to determine whether any legal violations exist. If no legal violations are evident, we will allow a corresponding link. We have no influence on the current and future design as well as content or offers of the linked pages. We therefore expressly distance ourselves from all contents of all linked pages, that have been changed, after the link has been set. This statement applies to all, within the own internet offer, set links and references. For illegal, incorrect or incomplete contents and in particular for damages resulting from the use or non-use of such kind of presented information the provider of the page, to which reference was made, is liable. With knowledge of legal offenses external links will be deleted immediately. Please advise us if necessary.

Copyright

The content and works, created by the site operators, on this site are liable to German copyright law. The duplication, processing, distribution and any kind of exploitation outside the limits of copyright require the written consent of the respective author or creator. Downloads and copies of this site are permitted for private and non-commercial use only. As far as the contents on this side were not created by the operator, the copyrights of third parties are considered. Should you still be aware of a copyright infringement, we ask for a corresponding note. Upon notification of violations we will remove such content immediately.
This website may not be displayed by third parties in frames or iframes without our written permission.

Advertising

The use of contact data published by third parties as part of the imprint obligation for the purpose of sending unsolicited advertising and information materials is hereby expressly excluded, unless the operator has given his written consent in advance or there is already a business relationship. The operator of the pages expressly reserves the right to take legal action in the event of unsolicited promotional information, such as spam e-mails.

PRIVACY NOTICE

Responsible in the sense of the data protection laws, in particular the EU General Data Protection Regulation (GDPR), is: Marion Wendt, Fichtenweg 22a in 46446 Emmerich am Rhein, Germany.

General

Your data will be collected on the one hand, by telling us this. This may be e.g. data you enter in the contact form.
Other data are automatically collected when visiting the website through IT systems. These are especially all technical data (e.g. internet browser, operating system or time of the page view). The collection of this data occurs automatically as soon as you visit our website. These data are elevated to ensure an error-free delivery of our website. Other data can be used to analyze your user behavior.
Your personal data (e.g. title, name, address, e-mail address, telephone number) will only be processed by us in accordance with the provisions of data privacy laws. The following explanations inform you about the nature, scope and purpose of the collection, processing and use of personal data. This privacy notice applies only to our website.

Server Log Files

When you access our website, i.e. even if you do not register or otherwise provide information, information of a general nature is automatically collected. This information (server log files) includes:

• IP address
• Date and time of the server request
• Request line
• Status code
• Size of the response body
• Referrer URL
• Browser type and browser version
• User operating system

They are processed in particular for the following purposes:

• Ensuring a hassle-free connection of the website
• Ensuring the smooth use and functionality of our website
• Statistical analysis
• Detection and defense against attacks
• Evaluation of system security and stability as well as for further administrative purposes

There is no merge of this data with other data sources. We do not use your information to draw conclusions about your person. Information of this kind may be statistically evaluated by us to optimize our website and the underlying technology.

The processing is carried out in accordance with Art. 6 para. 1 lit. f GDPR based on our legitimate interest in improving the stability and functionality of our website.

Contact Form

The data you enter will be stored for the purpose of individual communication with you. This requires a valid e-mail address and your name. This serves to assign the request and the subsequent answering of the same. The specification of further data is optional.
The processing of the data entered into the contact form takes place on the basis of a legitimate interest (Art. 6 para. 1 lit. f GDPR), because by providing the contact form we would like to enable for you to make an uncomplicated contact. Your information will be stored for the purpose of processing the request and for possible follow-up questions.
If you contact us to inquire about an offer, the processing of the data entered in the contact form will be used to carry out pre-contractual measures (Art. 6 para. 1 lit. f GDPR).
The data will be deleted no later than 6 months after processing the request.
If it comes to a contractual relationship, we are subject to the legal retention periods and delete your data after these deadlines.
The provision of your personal data is voluntary. However, we can only process your request if you provide us with your name, your e-mail address and the reason for the request.

SSL Encryption

This website uses SSL encryption for security reasons and to protect the transmission of sensitive content, such as the requests you send to us as the site operator. An encrypted connection is indicated by the browser's address bar changing from "http: //" to "https: //" and the lock icon in your browser bar. If SSL encryption is enabled, the data you submit to us cannot be read by third parties.
We indicate that the data transmission in the internet (e.g. in the case of communication by e-mail) can have security gaps. A complete protection of the data from access by third parties is not possible. This applies in particular if you contact us by e-mail on your own initiative. Here, yourself are responsible for taking appropriate measures to transmit your data securely and to protect against access by unauthorized third parties.

Your Rights

You can exercise the following rights at any time under the contact details provided:

• Information about your stored data and their processing (Art. 15 GDPR)
• Correction of incorrect personal data (Art. 16 GDPR)
• Deletion of your stored data (Art. 17 GDPR)
• Limitation of data processing, if we are not yet allowed to delete your data due to legal obligations (Art. 18 GDPR)
• Objection to the processing of your data with us (Art. 21 GDPR) and data portability, provided that you have consented to the data processing or have concluded a contract with us (Art. 20 GDPR)

If you have given us your consent, you can revoke it at any time with effect for the future. For this purpose and for further questions on the subject of personal data, you can contact us at any time under the contact details specified in the imprint.
You can contact a regulatory authority at any time with a complaint, such as: e.g. to the competent supervisory authority of the federal state of your domicile or to the authority responsible for us as responsible authority. A list of the supervisory authorities (for the non-public area) with address can be found at https://www.bfdi.bund.de/DE/Infothek/Anschriften_Links/anschriften_links-node.html.

Inclusion and Validity of the Privacy Notice

By using our website, you consent to the data processing described above. This privacy notice applies only to the content of our website. The linked external content is governed by other privacy and data security regulations. Who is responsible for these offers, you will find out in the respective imprint.
Due to the further development of our website or the implementation of new technologies, it may be necessary to change this privacy notice. We reserve the right to amend this privacy policy to always comply with the current legal requirements or to implement changes to our services in the privacy policy, e.g. when introducing new services. Your new visit will then be subject to the new privacy policy.

Status: January 2024