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Non-interventional Studies

Non-interventional Studies

 

Gaining information about medicinal products after their market authorization is becoming increasingly important.

 

We at Winicker Norimed plan and conduct non-interventional studies of your already authorized medicinal product with the highest quality.

 

Through a flexible project design, a thorough planning phase and customer-oriented solutions, we match our services to your needs and requirements.

 

You can trust our team of experts with the effective and efficient conduct of your NIS.

 

Depending on your requirements, we manage the following types of NIS:

 

  • Observational Studies
  • Post Authorisation Safety and Efficacy Studies (PASS / PAES)
  • Patient Reported Outcome Studies
  • Registries
  • Pharmacy-Based Observational Studies
  • Retrospective Data Collection
  • Epidemiological Studies

Our services for non-interventional Studies

Clinical Strategy Planning

Clinical Strategy Planning

 

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

Submissions

Submissions

 

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 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

Project Management

Project Management

 

After careful planning of your project we continue to support your study with successful project management.

 

Our experienced project managers 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
  • Coordinating point of contact for the  participating physicians and their team
  • Remuneration of participating study sites
  • Preparation of regular status reports

Monitoring

Monitoring

 

Quality assurance measures are gaining more and more importance in the area of non-interventional studies. Almost all studies are subject to monitoring whereby the extent of this quality assurance measure strongly depends on the study requirements and thus varies for each individual NIS

 

We consult you on the selection of suitable quality assurance measures and conduct the monitoring of your study for you.

 

Our CRAs are trained specifically for the monitoring requirement of non-interventional studies.

 

We provide you with the following services:

 

  • Iinitiation visits, monitoring visits (risk-based) and close-out visits
  • Remote Monitoring
  • Training of study staff on study requirements and safety reporting
  • Site management during throughout all study phases
  • Supporting investigation sites with safety reporting

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 and make sure that the evaluation of your clinical data is consistent and accurate.

 

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
  • Database development in accordance with CDISC standard
  • Electronic and paper-based CRF design
  • Data entry, validation and data cleaning (including Audit Trail)
  • Event coding (according to standard codebooks, MedDRA and WHO-DD)
  • Statistical analysis (on the basis of SAS)
  • Interim analysis

Medical Writing

Medical Writing

 

As a result of the increased requirements for non-interventional studies, the quality of study documents, such as observational plan and study report, is of utmost importance.

 

Our experienced medical writing team will take ownership of your needs!
Our range of medical writing services:

 

    • Observational plans
      • Non-interventional studies including post-authorization efficacy studies (PAES)
      • Post-authorization safety studies (PASS) according to EMA/623947/2012
    • Study reports
      • Study reports based on clinical study reports (CSRs) according to ICH-E3
      • PASS reports according to EMA/48663/2013
    • Publication manuscripts, abstracts & posters
      • Publication manuscripts in German or English in accordance with international guidelines as well as the specific author‘s guidelines
      • Organization of the peer review process
      • Abstracts and posters (in hard copy or electronically) according to the congress specifications
      • On-line submission

 

Pharmacovigilance

Pharmacovigilance

 

The regulatory requirements for the systematic surveillance and safety of your pharmaceutical product are extensive and require profound specialist expertise.

 

Our interdisciplinary team of experts combines experience with continuous training in the current regulatory requirements. We support you with the monitoring of your pharmaceutical product in compliance with all safety requirements.

 

We provide you with the following services:

 

  • Screening of data from non-interventional studies (NIS) and other data collections for safety relevant aspects
  • Medical Review
  • Preparation and Processing of  Individual Case Safety Reports (ICSR) including  Follow-ups
  • Entry of safety data into the sponsors’ databases
  • Electronic reporting of case reports to the relevant authorities
  • Translation of case-specific documents English-German / German-English (e.g. hospital letters, doctor’s letters)
  • Reconciliations
  • Preparation of the Periodic Safety Update Report (PSUR), monthly Safety Reports, the Risk Management Plan (RMP)

Quality Assurance & Audits

Quality Assurance & Audits

 

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

 

We provide you with the following services:

 

  • Consulting on SOPs and QM-relevant organizational structures
  • Conduct of internal audits in the context of the regular quality assurance measures
  • Recommendation of CAPA-measures in case of findings
  • Consulting on the corrections of internal and external finding

Medical Consulting

Medical Consulting

 

Scientific and medical consulting 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 advices and trains your project team continuously and during all project phases.

 

We provide you with the following services:

 

  • Medical and scientific consultation on study planning
  • Medical and scientific consultation departments
  • Consultation on scientific and clinical questions of investigators and their study teams
  • 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

Trainings

Trainings

 

Due to NIS growing complexity, thoroughly trained site personnel is more and more important for a successful conduct of your study.

 

We currently offer various curricular training programs that have achieved a high measure of acceptance not only with our clients but have also been accredited by some Medical Associations in  Germany (Landesärztekammern).

 

Non interventional studies (NIS) – training for physicians and site personnel (1 day)

 

  • The goal of our NIS training is to provide you with profound knowledge and practical skills for the conduct of non-interventional studies in accordance with all current guidelines and legal regulations.
  • Our training has been accredited by the Medical Association of Bavaria (Bayerische Landesärztekammer). 6 Continuing Medical Education points (CME) have been assigned so far.

 

 

Non interventional studies (NIS) – specialized training for monitors (1 day)

 

  • The aim of our training is to provide CRAs with profound knowledge about non-interventional studies (NIS) and tips for the practical conduct of NIS monitoring.

We pay particular attention to the fine differences in monitoring between NIS and clinical trials.

Clinical Strategy Planning

Clinical Strategy Planning

 

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

Submissions

Submissions

 

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 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

Project Management

Project Management

 

After careful planning of your project we continue to support your study with successful project management.

 

Our experienced project managers 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
  • Coordinating point of contact for the  participating physicians and their team
  • Remuneration of participating study sites
  • Preparation of regular status reports

Monitoring

Monitoring

 

Quality assurance measures are gaining more and more importance in the area of non-interventional studies. Almost all studies are subject to monitoring whereby the extent of this quality assurance measure strongly depends on the study requirements and thus varies for each individual NIS

 

We consult you on the selection of suitable quality assurance measures and conduct the monitoring of your study for you.

 

Our CRAs are trained specifically for the monitoring requirement of non-interventional studies.

 

We provide you with the following services:

 

  • Iinitiation visits, monitoring visits (risk-based) and close-out visits
  • Remote Monitoring
  • Training of study staff on study requirements and safety reporting
  • Site management during throughout all study phases
  • Supporting investigation sites with safety reporting

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 and make sure that the evaluation of your clinical data is consistent and accurate.

 

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
  • Database development in accordance with CDISC standard
  • Electronic and paper-based CRF design
  • Data entry, validation and data cleaning (including Audit Trail)
  • Event coding (according to standard codebooks, MedDRA and WHO-DD)
  • Statistical analysis (on the basis of SAS)
  • Interim analysis

Medical Writing

Medical Writing

 

As a result of the increased requirements for non-interventional studies, the quality of study documents, such as observational plan and study report, is of utmost importance.

 

Our experienced medical writing team will take ownership of your needs!
Our range of medical writing services:

 

    • Observational plans
      • Non-interventional studies including post-authorization efficacy studies (PAES)
      • Post-authorization safety studies (PASS) according to EMA/623947/2012
    • Study reports
      • Study reports based on clinical study reports (CSRs) according to ICH-E3
      • PASS reports according to EMA/48663/2013
    • Publication manuscripts, abstracts & posters
      • Publication manuscripts in German or English in accordance with international guidelines as well as the specific author‘s guidelines
      • Organization of the peer review process
      • Abstracts and posters (in hard copy or electronically) according to the congress specifications
      • On-line submission

 

Pharmacovigilance

Pharmacovigilance

 

The regulatory requirements for the systematic surveillance and safety of your pharmaceutical product are extensive and require profound specialist expertise.

 

Our interdisciplinary team of experts combines experience with continuous training in the current regulatory requirements. We support you with the monitoring of your pharmaceutical product in compliance with all safety requirements.

 

We provide you with the following services:

 

  • Screening of data from non-interventional studies (NIS) and other data collections for safety relevant aspects
  • Medical Review
  • Preparation and Processing of  Individual Case Safety Reports (ICSR) including  Follow-ups
  • Entry of safety data into the sponsors’ databases
  • Electronic reporting of case reports to the relevant authorities
  • Translation of case-specific documents English-German / German-English (e.g. hospital letters, doctor’s letters)
  • Reconciliations
  • Preparation of the Periodic Safety Update Report (PSUR), monthly Safety Reports, the Risk Management Plan (RMP)

Quality Assurance & Audits

Quality Assurance & Audits

 

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

 

We provide you with the following services:

 

  • Consulting on SOPs and QM-relevant organizational structures
  • Conduct of internal audits in the context of the regular quality assurance measures
  • Recommendation of CAPA-measures in case of findings
  • Consulting on the corrections of internal and external finding

Medical Consulting

Medical Consulting

 

Scientific and medical consulting 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 advices and trains your project team continuously and during all project phases.

 

We provide you with the following services:

 

  • Medical and scientific consultation on study planning
  • Medical and scientific consultation departments
  • Consultation on scientific and clinical questions of investigators and their study teams
  • 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

Trainings

Trainings

 

Due to NIS growing complexity, thoroughly trained site personnel is more and more important for a successful conduct of your study.

 

We currently offer various curricular training programs that have achieved a high measure of acceptance not only with our clients but have also been accredited by some Medical Associations in  Germany (Landesärztekammern).

 

Non interventional studies (NIS) – training for physicians and site personnel (1 day)

 

  • The goal of our NIS training is to provide you with profound knowledge and practical skills for the conduct of non-interventional studies in accordance with all current guidelines and legal regulations.
  • Our training has been accredited by the Medical Association of Bavaria (Bayerische Landesärztekammer). 6 Continuing Medical Education points (CME) have been assigned so far.

 

 

Non interventional studies (NIS) – specialized training for monitors (1 day)

 

  • The aim of our training is to provide CRAs with profound knowledge about non-interventional studies (NIS) and tips for the practical conduct of NIS monitoring.

We pay particular attention to the fine differences in monitoring between NIS and clinical trials.

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