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Medical Devices

Medical Devices

 

Your reliable partner in clinical research

 

Winicker Norimed GmbH is a reliable partner in the field of clinical research with medical devices. With the highest quality of service, we plan and conduct clinical investigations with medical devices in accordance with the relevant national regulations and international standards (ISO 14155).

 

Our team of qualified specialists draws on years of experience in the medical device industry. The main focus of our work has been placed on Germany and Europe.

 

Through our long-term cooperation in various projects, we were able to establish a profound network of clinical partners and experts. Use our professional network to guarantee the successful conduct and finalization of your project!

 

Our services for Medical Device studies:

 

Clinical Strategy Planning

Clinical Strategy Planning

 

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 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

Submissions

Submissions

 

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
  • Consulting on and preparation of interim reports as well as clinical investigation reports (including Safety Reports) for EC/CA submission

Project Management

Project Management

 

After your clinical study design has been finalized and submitted to the CA / EC, we continue to support your clinical investigation in the area of project management.

 

To ensure a reliable and valid data collection, our project managers and experts for medical device studies supervise your projects with the utmost care.

 

We provide you with the following services:

 

  • Project controlling, including budget and milestone management
  • Contract management
  • Study-specific training of all parties involved
  • Maintenance of the Trial Master File including preparation of site files
  • Organization and conduct of investigator meetings
  • Coordinating point of contact for the investigation sites and their team
  • Communication with the respective competent authorities and ethics committee

Monitoring

Monitoring

 

We provide you with further measures of quality assurance for your project by performing clinical monitoring. Our team of CRAS is specialized in monitoring clinical investigations with medical devices.

 

Our services in monitoring:

 

  • On-site visits: (in accordance with ISO 14155)
    • qualification visits
    • initiation visits
    • monitoring visits (risk-based)
    • close-out visits
  • Remote Monitoring
  • Training of the investigational sites for individual studies, tailored to the specific regulatory requirements of medical device clinical investigations
  • Supporting investigational sites with safety reporting, and support with the management of queries
  • Support of the participating investigation sites with the preparation for audits and inspections

Data Management & Biostatistics

Data Management & Biostatistics

 

Our team at Winicker Norimed has many years of experience in data management and biostatistics. Our data managers, coders and biometricians will take ownership of your needs to ensure a valid  statistical analysis

 

Our experts will positively engage in your project. We will work closely together with you to make sure that the focus of our work is directed towards achieving your project-specific goals.

 

We provide you with the following services:

 

  • Statistical consulting
  • Statistical analysis plan
  • Randomization
  • Database development in accordance with CDISC standard
  • Electronic and paper-based CRF design
  • Data entry, validation and data cleaning (including Audit Trail)
  • Coding (according to standard codebooks, MedDRA and WHO-DD or according to sponsor-specific codebooks)
  • Statistical analysis (on the basis of SAS)
  • Interim analysis
  • Analysis for Data and Safety Monitoring Boards (DSMB)
  • Metaanalysis

Medical Writing

Medical Writing

 

Besides thorough planning, a clearly written clinical investigation plan (CIP) is the premise for a successful conduct of your medical device project. One of the last steps to ensure an equally successful completion of your project is the preparation of a comprehensive clinical investigation report (CIR). Apart from being mandatory for CA/EC submission , the CIR is also essential for the presentation of your data in the context of the CE-conformity assessment or the recertification procedure.

 

We provide you with the following services:

 

  • Clinical investigations plans according to ISO14155 and MEDDEV
  • Interim reports for submission to ethical committees and competent authorities
  • Clinical investigation reports in accordance with ISO14155 and all its relevant attachments
  • Safety reports (both final reports and regular reports as required)
  • Posters, abstracts
  • Publication manuscripts

 

Vigilance

Vigilance

 

The medical device industry is an innovation-oriented and rapidly developing field that is subject to continually increasing regulatory requirements. These requirements differ significantly from those in the pharmaceutical industry and affect the medical device vigilance in particular.

 

We provide you with the following services:

 

  • Screening of data from clinical investigations with medical devices
    • Case Processing for cases reported in medical device studies, incl. conduct of Follow-up procedure
    • Medical Review
  • Support with incident processing in close collaboration with your medical device safety officer
    • Processing of Line Listings (in accordance with MEDDEV 2 7/3, also for European competent authorities)
  • Entry of safety data into the sponsors’ databases or relevant (national) reporting forms
  • Translation of case-specific documents English-German / German-English (e.g. hospital letters, doctor’s letters)
  • Reconciliations
  • Support with the preparation of Safety Reports

Quality Assurance & Audits

Quality Assurance & Audits

 

Quality assurance through internal audits is essential for a compliant conduct of your clinical investigations with medical devices.

 

Our independent and experienced team of experts at Winicker Norimed is specialized in quality assurance in medical device clinical investigations. We conduct audits in accordance with current regulatory requirements at investigation sites on your behalf or at your premises.

 

Our well-established quality assurance measures help you to develop countermeasures for risk mitigation, to optimize work processes and to prepare your project for inspections.

 

We provide you with the following services:

 

  • Consulting on SOPs and QM-relevant organizational structures
  • Conduct of internal audits at the Sponsor’s premises and the investigation sites as part of routine quality assurance programme and as preparation for potential regulatory inspections
  • Recommendation of CAPA-measures in case of findings

 

Medical Consulting

Medical Consulting

 

Scientific and medical consulting as well as training are essential for your successful planning and conduct of your study.

 

We offer our consulting services and training based on up-to-date scientific standards for a wide range of medical topics. Out team of medical doctors and experts in clinical investigations with medical devices advices and trains your project team continuously and during all project phases.

 

We provide you with the following services:

 

  • Medical and scientific consultation of the departments
  • Consultation on scientific and clinical questions of investigators and their study teams and during the field phase
  • Development of the Medical Review Plan
  • Medical evaluation of adverse events
  • Preparation of medical queries and monitoring of the query process
  • Medical training for study personel (internal and external)

Trainings

Trainings

 

Prior to participation in a clinical investigation according to MPG, the ethical committees and competent authorities demand a certified qualification in “Good Clinical Practice” (ISO-GCP according to ISO 14155) as well as in the current national regulations (MPG, MPKPV, MPSV).

 

We help you to meet these requirements!

 

Winicker Norimed provides you with trainings on Good Clinical Practice in clinical investigations with medical devices.

 

We provide you with the following services:

 

Information about our training programs and registration

You can find more information about our training programs as well as training registration in our training area (this site is only available in German).

Clinical Strategy Planning

Clinical Strategy Planning

 

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 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

Submissions

Submissions

 

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
  • Consulting on and preparation of interim reports as well as clinical investigation reports (including Safety Reports) for EC/CA submission

Project Management

Project Management

 

After your clinical study design has been finalized and submitted to the CA / EC, we continue to support your clinical investigation in the area of project management.

 

To ensure a reliable and valid data collection, our project managers and experts for medical device studies supervise your projects with the utmost care.

 

We provide you with the following services:

 

  • Project controlling, including budget and milestone management
  • Contract management
  • Study-specific training of all parties involved
  • Maintenance of the Trial Master File including preparation of site files
  • Organization and conduct of investigator meetings
  • Coordinating point of contact for the investigation sites and their team
  • Communication with the respective competent authorities and ethics committee

Monitoring

Monitoring

 

We provide you with further measures of quality assurance for your project by performing clinical monitoring. Our team of CRAS is specialized in monitoring clinical investigations with medical devices.

 

Our services in monitoring:

 

  • On-site visits: (in accordance with ISO 14155)
    • qualification visits
    • initiation visits
    • monitoring visits (risk-based)
    • close-out visits
  • Remote Monitoring
  • Training of the investigational sites for individual studies, tailored to the specific regulatory requirements of medical device clinical investigations
  • Supporting investigational sites with safety reporting, and support with the management of queries
  • Support of the participating investigation sites with the preparation for audits and inspections

Data Management & Biostatistics

Data Management & Biostatistics

 

Our team at Winicker Norimed has many years of experience in data management and biostatistics. Our data managers, coders and biometricians will take ownership of your needs to ensure a valid  statistical analysis

 

Our experts will positively engage in your project. We will work closely together with you to make sure that the focus of our work is directed towards achieving your project-specific goals.

 

We provide you with the following services:

 

  • Statistical consulting
  • Statistical analysis plan
  • Randomization
  • Database development in accordance with CDISC standard
  • Electronic and paper-based CRF design
  • Data entry, validation and data cleaning (including Audit Trail)
  • Coding (according to standard codebooks, MedDRA and WHO-DD or according to sponsor-specific codebooks)
  • Statistical analysis (on the basis of SAS)
  • Interim analysis
  • Analysis for Data and Safety Monitoring Boards (DSMB)
  • Metaanalysis

Medical Writing

Medical Writing

 

Besides thorough planning, a clearly written clinical investigation plan (CIP) is the premise for a successful conduct of your medical device project. One of the last steps to ensure an equally successful completion of your project is the preparation of a comprehensive clinical investigation report (CIR). Apart from being mandatory for CA/EC submission , the CIR is also essential for the presentation of your data in the context of the CE-conformity assessment or the recertification procedure.

 

We provide you with the following services:

 

  • Clinical investigations plans according to ISO14155 and MEDDEV
  • Interim reports for submission to ethical committees and competent authorities
  • Clinical investigation reports in accordance with ISO14155 and all its relevant attachments
  • Safety reports (both final reports and regular reports as required)
  • Posters, abstracts
  • Publication manuscripts

 

Vigilance

Vigilance

 

The medical device industry is an innovation-oriented and rapidly developing field that is subject to continually increasing regulatory requirements. These requirements differ significantly from those in the pharmaceutical industry and affect the medical device vigilance in particular.

 

We provide you with the following services:

 

  • Screening of data from clinical investigations with medical devices
    • Case Processing for cases reported in medical device studies, incl. conduct of Follow-up procedure
    • Medical Review
  • Support with incident processing in close collaboration with your medical device safety officer
    • Processing of Line Listings (in accordance with MEDDEV 2 7/3, also for European competent authorities)
  • Entry of safety data into the sponsors’ databases or relevant (national) reporting forms
  • Translation of case-specific documents English-German / German-English (e.g. hospital letters, doctor’s letters)
  • Reconciliations
  • Support with the preparation of Safety Reports

Quality Assurance & Audits

Quality Assurance & Audits

 

Quality assurance through internal audits is essential for a compliant conduct of your clinical investigations with medical devices.

 

Our independent and experienced team of experts at Winicker Norimed is specialized in quality assurance in medical device clinical investigations. We conduct audits in accordance with current regulatory requirements at investigation sites on your behalf or at your premises.

 

Our well-established quality assurance measures help you to develop countermeasures for risk mitigation, to optimize work processes and to prepare your project for inspections.

 

We provide you with the following services:

 

  • Consulting on SOPs and QM-relevant organizational structures
  • Conduct of internal audits at the Sponsor’s premises and the investigation sites as part of routine quality assurance programme and as preparation for potential regulatory inspections
  • Recommendation of CAPA-measures in case of findings

 

Medical Consulting

Medical Consulting

 

Scientific and medical consulting as well as training are essential for your successful planning and conduct of your study.

 

We offer our consulting services and training based on up-to-date scientific standards for a wide range of medical topics. Out team of medical doctors and experts in clinical investigations with medical devices advices and trains your project team continuously and during all project phases.

 

We provide you with the following services:

 

  • Medical and scientific consultation of the departments
  • Consultation on scientific and clinical questions of investigators and their study teams and during the field phase
  • Development of the Medical Review Plan
  • Medical evaluation of adverse events
  • Preparation of medical queries and monitoring of the query process
  • Medical training for study personel (internal and external)

Trainings

Trainings

 

Prior to participation in a clinical investigation according to MPG, the ethical committees and competent authorities demand a certified qualification in “Good Clinical Practice” (ISO-GCP according to ISO 14155) as well as in the current national regulations (MPG, MPKPV, MPSV).

 

We help you to meet these requirements!

 

Winicker Norimed provides you with trainings on Good Clinical Practice in clinical investigations with medical devices.

 

We provide you with the following services:

 

Information about our training programs and registration

You can find more information about our training programs as well as training registration in our training area (this site is only available in German).

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