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Clinical Trials Phase II – IV

Clinical Trials Phase II – IV

 

Our team of qualified specialists at Winicker Norimed plans and manages clinical trials phase II –IV for pharmaceutical companies, biotech companies, universities and research institutes. We plan your study with the highest quality of service and in accordance with the relevant national regulations and international standards.

 

As contract research institute with seat in Germany, the main focus of your work has been placed on national projects. Through our long-term cooperative projects, we were able to continuously expand our network on international clinical partners and experts and are thus able to support you with your international studies as coordinating CRO. We are your reliable partner throughout each project stage.

 

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

 

Our Services for Clinical Trials Phase II – IV:

Clinical Strategy Planning

Clinical Strategy Planning

 

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

Submissions

Submissions

 

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
  • 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, we continue to support your clinical trial with efficient project management.

 

Our experienced and highly-qualified project managers are very engaged, they supervise your projects with the utmost care.

 

We provide you with the following services:

 

  • Project controlling, including budget controlling and milestone management
  • Contract management
  • Study-specific training of all parties involved
  • Maintenance of the Trial Master File
  • 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 at Winicker Norimed provide you with further measures of quality assurance for your project by performing clinical monitoring

 

Apart from our in-house CRAs, we have a large number of qualified freelancer CRAs at our disposal. This allows us to operate highly cost-oriented and flexible.

 

We provide you with the following services:

 

  • On-site monitoring
    • qualifications visits
    • initiation visits
    • monitoring visits (risk-based)
    • close-out visits
  • Remote Monitoring
  • Training of the investigational sites for specific study requirements
  • Site management
  • Supporting investigational sites with safety reporting, and support with the management of queries
  • Support of the study sites in 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)
  • Event coding (according to standard codebooks, MedDRA and WHO-DD)
  • Statistical analysis (on the basis of SAS)
  • Interim Analysis
  • Analysis for Data and Safety Monitoring Boards (DSMB)
  • Metaanalysis

Medical Writing

Medical Writing

 

Our team of experienced medical writers has profound experience in the preparation of clinical study protocols, clinical study reports, submission documents, abstracts, posters, publications and further scientific information materials. Moreover, we generate risk management plans, periodic safety update reports etc. (safety writing). In close cooperation with our specialized departments, we achieve the highest quality of services.

 

Do not hesitate to contact us, if you have further requests in medical writing.

 

We provide you with the following services:

 

  • Clinical study protocols, reports and other regulatory documents
    • Clinical Study Protocols (CSPs) according to ICH-E6
    • Clinical Study Reports (CSRs) according to ICH-E3
    • Clinical Overview (Module 2.5), Summary of Clinical Efficacy (Module 2.7.3), Summary of Clinical Safety (Module 2.7.4) in CTD format according to ICH-M4
    • Investigator’s Brochure (IB)
    • Clinical parts of the Investigational Medicinal Product Dossiers (IMPD) according to EC Directive 2001/20/EC
  • Safety writing
    • Risk Management Plans (RMPs)
    • Development Safety Update Reports (DSURs)
    • Periodic Safety Update Reports (PSURs)
  • Publication manuscripts, abstracts & posters
    • Publication manuscripts in German or English language in accordance with international guidelines as well as 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 safety surveillance of your pharmaceutical product are extensive and require profound know how.

 

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 clinical trials for safety relevant aspects
  • Preparation and Processing of Individual Case Safety Reports (ICSR) including Follow-up
  • Medical Reviews
  • 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), the Developement Safety Update Reports (DSUR), monthly Safety Reports, the Risk Management Plan (RMP)

Quality Assurance

Quality Assurance

 

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

 

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

 

Our auditors 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 investigational sites
  • Recommendation of CAPA-measures in case of findings

Medical Consulting

Medical Consulting

 

Scientific and medical consulting as well as medical 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. Our team of medical doctors and experts advices and trains your project team continuously to your needs.

 

We provide you with the following services:

 

  • Medical consulting 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 personnel (internal and external)

Trainings

Trainings

 

Thoroughly trained site personnel is essential for a successful conduct of your study.

 

We offer trainings for physicians, study nurses and study assistants as well as other parties working in the pharmaceutical industry.

 

Our training has been certified with 20 points by the German Medical Association

 

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 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

Submissions

Submissions

 

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
  • 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, we continue to support your clinical trial with efficient project management.

 

Our experienced and highly-qualified project managers are very engaged, they supervise your projects with the utmost care.

 

We provide you with the following services:

 

  • Project controlling, including budget controlling and milestone management
  • Contract management
  • Study-specific training of all parties involved
  • Maintenance of the Trial Master File
  • 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 at Winicker Norimed provide you with further measures of quality assurance for your project by performing clinical monitoring

 

Apart from our in-house CRAs, we have a large number of qualified freelancer CRAs at our disposal. This allows us to operate highly cost-oriented and flexible.

 

We provide you with the following services:

 

  • On-site monitoring
    • qualifications visits
    • initiation visits
    • monitoring visits (risk-based)
    • close-out visits
  • Remote Monitoring
  • Training of the investigational sites for specific study requirements
  • Site management
  • Supporting investigational sites with safety reporting, and support with the management of queries
  • Support of the study sites in 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)
  • Event coding (according to standard codebooks, MedDRA and WHO-DD)
  • Statistical analysis (on the basis of SAS)
  • Interim Analysis
  • Analysis for Data and Safety Monitoring Boards (DSMB)
  • Metaanalysis

Medical Writing

Medical Writing

 

Our team of experienced medical writers has profound experience in the preparation of clinical study protocols, clinical study reports, submission documents, abstracts, posters, publications and further scientific information materials. Moreover, we generate risk management plans, periodic safety update reports etc. (safety writing). In close cooperation with our specialized departments, we achieve the highest quality of services.

 

Do not hesitate to contact us, if you have further requests in medical writing.

 

We provide you with the following services:

 

  • Clinical study protocols, reports and other regulatory documents
    • Clinical Study Protocols (CSPs) according to ICH-E6
    • Clinical Study Reports (CSRs) according to ICH-E3
    • Clinical Overview (Module 2.5), Summary of Clinical Efficacy (Module 2.7.3), Summary of Clinical Safety (Module 2.7.4) in CTD format according to ICH-M4
    • Investigator’s Brochure (IB)
    • Clinical parts of the Investigational Medicinal Product Dossiers (IMPD) according to EC Directive 2001/20/EC
  • Safety writing
    • Risk Management Plans (RMPs)
    • Development Safety Update Reports (DSURs)
    • Periodic Safety Update Reports (PSURs)
  • Publication manuscripts, abstracts & posters
    • Publication manuscripts in German or English language in accordance with international guidelines as well as 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 safety surveillance of your pharmaceutical product are extensive and require profound know how.

 

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 clinical trials for safety relevant aspects
  • Preparation and Processing of Individual Case Safety Reports (ICSR) including Follow-up
  • Medical Reviews
  • 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), the Developement Safety Update Reports (DSUR), monthly Safety Reports, the Risk Management Plan (RMP)

Quality Assurance

Quality Assurance

 

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

 

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

 

Our auditors 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 investigational sites
  • Recommendation of CAPA-measures in case of findings

Medical Consulting

Medical Consulting

 

Scientific and medical consulting as well as medical 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. Our team of medical doctors and experts advices and trains your project team continuously to your needs.

 

We provide you with the following services:

 

  • Medical consulting 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 personnel (internal and external)

Trainings

Trainings

 

Thoroughly trained site personnel is essential for a successful conduct of your study.

 

We offer trainings for physicians, study nurses and study assistants as well as other parties working in the pharmaceutical industry.

 

Our training has been certified with 20 points by the German Medical Association

 

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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