Project management at Winicker Norimed
Thorough planning and steering are essential cornerstones
We design and plan your clinical studies on medicinal products in accordance with international standards (ICH-GCP), national regulations (such as the AMG [the German drug law]) and taking into consideration relevant literature. For medical devices, we work in accordance with international standards (product specific ISO standard, ISO-14155 etc.) and national regulations (e.g. MPG [German Medical Devices Act], MPKPV (Ordinance on Clinical Trials with Medical Devices) and MPSV (Safety Plan for Medical Devices).
Intensive planning and management is crucial for successful and cost-efficient study conduct.
Our team of experienced project managers supports you by evaluating your project’s feasibility. After meticulous planning, we can then also help with efficient project management.
Our team of experts possesses in-depth know-how on national and international requirements and regulations and will support you with submissions to Ethics Committees and competent authorities in Germany and throughout Europe. Our specialists adhere to local and international standards as well as AMG and GCP requirements and report to all relevant committees and authorities such as the BfArM (the German Federal Institute for Drugs and Medical Devices), PEI (Paul Ehrlich Institute), BfS (German Federal Office for Radiation Protection), National Association of Statutory Health Insurance Physicians etc.
Our range of services
In planning and management
Clinical strategy planning
- Consultation on study design
- Conduct of feasibility studies
- Statistical consulting and sample size calculation
- Preparation of study-specific documents, including the study protocol or obersvational plan, informed consent forms and the case report forms (paper CRF or eCRF)
- Planning of quality assurance measures (monitoring, audits and preparation for inspections)
- Support in the preparation of the Investigator’s Brochure
- Identification and selection of suitable study sites
- Obtaining essential documents from the involved sites and creation of the required application documents for submission to the Ethics Committees and competent authorities
- Notifying the relevant local authoritities about your project
Project management
- 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 study sites and their team
- Communication with the respective Ethics Committees and competent authorities
- Creation of periodic status reports
Winicker Norimed GmbH
Deutschherrnstraße 15-19, 90429 Nuremberg
Phone: +49 (0) 911 / 9 26 80 – 0
Fax: +49 (0) 911 / 9 26 80 – 8839
E-Mail: wn@winicker-norimed.com