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Clinical Strategy Planning

Clinical Trials Phase II - IVNon-interventional StudiesMedical DevicesNutritional Supplements

Clinical Strategy Planning – Clinical Trials Phase II – IV

 

Thorough planning of your clinical trial is essential for a successful and cost-efficient study conduct.

 

Use our extensive experience to ensure optimal strategy planning of your clinical trial!

 

Our project managers can support you by reviewing the overall strategy, clinical practice and clinical acceptance of your project as well as its compliance with ethical standards.

 

We provide you with the following services:

 

  • Consultation on study design, including the evaluation of your project regarding it’s feasibility and the current national and international regulations
  • Conduct of feasibility studies
  • Clinical strategy planning and conceptual design for clinical trials in accordance with international standards ( ICH-GCP.), national laws ( AMG) as well as relevant literature
  • Preparation of study specific documents, including the clinical investigation plan (according to ICH-E6), patient information, informed consent and the case report forms (electronic and/or paper-based)
  • Support regarding the preparation of the Investigator’s Brochure
  • Planning clinical quality assurance measures (e.g. monitoring, audits and inspection preparation)
  • Identification and selection of qualified investigators

 

Your contacts for Clinical Strategy Planning – 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

Clinical Strategy Planning – Non-interventional Studies

 

Thorough planning of your non-interventional study is essential for a successfully and cost-efficient study conduct

 

Use our extensive experience to ensure optimal strategy planning of your non-interventional study!

 

Our project managers can support you by reviewing the overall strategy and clinical acceptance of your project as well as its compliance with ethical standards.

 

We provide you with the following services:

 

  • Consultation on study design
  • Conduct of feasibility studies
  • Statistical advice and sample size estimation
  • Preparation of study specific documents, including the study protocol, patient information, informed consent and the case report forms (electronic and/or paper-based)
  • Planning clinical quality assurance measures (e.g. monitoring, audits)
  • Selection of participating physicians

Your contact for Clinical Strategy Planning – Non-interventional Studies

Karin Blankenhorn

Karin Blankenhorn

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

Clinical Strategy Planning – Medical Devices

 

Thorough planning and conduct of your clinical investigation is essential to launch your medical device successfully and cost-efficiently.

 

Use our extensive experience to ensure optimal strategy planning of your medical device projects!

 

Our project managers can support you by reviewing the technical realization, clinical practice and clinical acceptance of your project as well as its compliance with ethical standards.

 

We provide you with the following services:

 

  • Consultation on study design, including the evaluation of your project regarding the compliance with the current national and international regulations (e.g. §§20-23a MPG, §23b MPG)
  • The preparation of an overall design for your clinical investigations in the context of the CE-Conformity Assessment Procedure or the Recertification Procedure
  • Clinical strategy planning and conceptual design for clinical projects in accordance with international standards (product-specific ISO standards, ISO-14155, etc.), national regulations (e.g. MPG, MPKPV, MPSV) as well as relevant literature
  • Preparation of study specific documents, including the clinical investigation plan, patient information, informed consent and the case report forms (electronic and/or paper-based)
  • Support regarding the preparation of the Investigator’s Brochure (in accordance with Annex B of ISO 14155)
  • Planning clinical quality assurance measures (e.g. monitoring, audits and inspection preparation)
  • Identification and selection of qualified investigators

Your contact for Clinical Strategy Planning – Medical Devices

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

Clinical Strategy Planning – Nutritional Supplements

 

Thorough planning of your study with nutritional products with health promoting properties is essential for a successfully and cost-efficient study conduct.
Use our extensive experience to ensure optimal strategy planning of your projects.

 

Our project managers can support you by reviewing the overall strategy and clinical acceptance of your project as well as its compliance with ethical standards.

 

We provide you with the following services:

 

  • Distinction between dietary supplements and pharmaceutical products
  • Consultation on study design, including the evaluation of your project regarding its feasibility and the current national and international regulations.
  • Conduct of feasibility studies
  • The preparation of an overall design for your projects in accordance with the relevant national and international regulations as well as with the relevant literature.
  • Preparation of study specific documents, including the clinical investigation plan, patient information, informed consent and the case report forms (electronic and/or paper-based)
  • Planning of quality assurance measures (monitoring, audits)

Your contact for Clinical Strategy Planning – Nutritional Supplements

Sabine Dürnhöfer

Sabine Dürnhöfer

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

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