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Submissions

Clinical Trials Phase II - IVNon-interventional StudiesMedical DevicesNutritional Supplements

Submissions – Clinical Trials Phase II – IV

 

Submissions of clinical trials to competent authorities (CA) and ethics committees (EC) are time-sensitive, time-consuming and cost-intensive. Our team of experts has profound knowledge regarding the national and international requirements for the CA/EC submissions.

 

Our experienced team at Winicker Norimed will support you with submissions to competent authorities and ethics committees in Germany and the European area.

 

We’re a full-service contract research organization and offer you a wide range of services. We provide you with the help you need to make your project a success: from individual consultations on submission procedures up to the complete performance of your planned submissions.

 

We provide you with the following services:

 

  • Preparation of the documents relevant for submissions to ethics committees (according to GCP-V) or competent authorities (BfArM, PEI, BfS)
  • Obtaining essential documents from the investigational sites
  • Submission of your clinical trial to the competent authorities and ethical committees
  • Notifying the relevant local authorities about your project

Your contacts for Submissions – Clinical Trials Phase II – IV

Sabine Dürnhöfer

Sabine Dürnhöfer

Dipl.-Biol.
Sabine.Duernhoefer@ winicker-norimed.com
+49 (0) 911 / 9 26 80 8730

Dr. Markus Hillgärtner

Dr. Markus Hillgärtner

Markus.Hillgaertner@ winicker-norimed.com
+49 (0) 911 / 9 26 80 8767

Submissions – Non-interventional Studies

 

Submissions of non-interventional studies to ethics committees and notifying the National Association of Statutory Health Insurance Physicians (kassenärztliche Bundesvereinigungen) as well as the National Association of Statutory Health Insurance Funds (KBV/GKV) are a prerequisite for study start.

 

Trust in our extensive experience in preparing the documents and submission to ethics committees and authorities.

 

We provide you with the following services:

 

  • Preparation of the documents relevant for submissions to ethics committees
  • Initial notification of the NIS according to 67(6) AMG to the competent authorities (BfArM/PEI)
  • Submission to ethic committees
  • Notifying the the National Association of Statutory Health Insurance Physicians as well as the National Association of Statutory Health Insurance Funds (KBV/PKV)
  • Follow-up notification and final notification to the KBV/PKV within the context of remuneration

Your contact for Submissions – Non-interventional Studies

Karin Blankenhorn

Karin Blankenhorn

Dipl.-Biol. 
Karin.Blankenhorn@winicker-norimed.com
+49 (0) 911 / 9 26 80 8932

Submissions – Medical Devices

 

Clinical investigations with medical devices are subject to strict regulatory requirements. Submissions of clinical trials to competent authorities (CA) and ethics committees (EC) are time-sensitive, time-consuming and cost-intensive. This requires thorough preparation and planning as well as profound experience in dealing with all parties involved.

 

Our experienced team at Winicker Norimed will support you with submissions to competent authorities and ethics committees in Germany and the European area.

 

We’re a full-service contract research organization and offer you a wide range of services. We provide you with the help you need to make your project a success: from individual consultations on submission procedures up to the complete performance of your planned submissions.

 

We provide you with the following services:

 

  • Preparation of the documents relevant for submissions to ethics committees or competent authorities
  • Obtaining essential documents from the investigational sites
  • Submission (and deregistration) of medical device studies to the competent authorities and ethical commissions in Germany and Europe

Your contact for Submissions – Medical Devices

medizinprodukte@winicker-norimed.com
+49 (0) 911 / 9 26 80 0

Submissions – Nutritional Supplements

 

As clinical investigations with nutritional products with health promoting properties are categorized as “free or other research projects”, it is obligatory for physicians that participate in such a clinical investigation to receive consultation by an ethical committee according to §15 BO (German professional code for physicians)

 

Registration of your study with the ethical committees.

 

We provide you with the following services:

 

  • Preparation of the documents relevant for submissions to ethics committees
  • Obtaining essential documents from the investigational sites
  • Submission (and deregistration) of clinical investigations with health-promoting properties ethical committees

Your contact for Submissions – Nutritional Supplements

Sabine Dürnhöfer

Sabine Dürnhöfer

Dipl.-Biol.
Sabine.Duernhoefer@winicker-norimed.com
+49 (0) 911 / 9 26 80 8730

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