Winicker Norimed GmbH

Scientific and medical consulting as well as training in the medical indications 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 of the /through our specialist 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)

Quality assurance through 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

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.

Our range of medical writing 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

Data Management & Biostatistics – Clinical Trials Phase II – IV

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

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

Project Management – Clinical Studies Phase II – IV

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

Scientific and medical consulting as well as training in the medical indications 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 of the /through our specialist 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)

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