NSF Clinical Affairs and Regulatory Services
Clinical Affairs and Medical Writing
• Creation and updating of documents and applications for clinical trials, including: • Clinical investigation and study plans. • Clinical study reports. • Case report forms (CRF). • Investigator's brochure (IB). • Patient information and informed consent forms (ICF). • Monitoring and evaluation of clinical studies, covering: • Clinical monitoring. • Clinical data management. • Statistical analysis of clinical data. • Development of strategies for post-market clinical follow-up (PMCF). • Generation of clinical data through various methods such as studies and surveys. • Creation of plans and reports for post-market clinica 01000-0. • Creation and updating of DSLID DMSD. • Creation of processes and templates specifically for the clinical affairs area. • Execution and updating of clinical evaluations according to the EU MDR (Medical Device Regulation). • Execution and updating of performance evaluations according to the EU IVDR (In Vitro Diagnostic Regulation). • Creation and updating of plans and reports for biological evaluation. • Development of Common Technical Documents (CTD) for use in the pharmaceutical industry. • Creation of topic-specific summaries derived from extensive literature searches (utilizing databases such as Pubmed, Embase, etc.) to obtain necessary preclinical and clinical data. • Clinical evaluation and verification of marketing claims. • Creation of benefit-risk assessments.
Specialized Regulatory Reports and Scientific Communication
• Creation and updating of safety and performance reports, including: • Periodic Safety Update Reports (PSUR). • Post-Market Surveillance Reports (PMSR). • Periodic Benefit-Risk Evaluation Reports (PBRER). • Creation and updating of specific summary documents: • Summary of Safety and Clinical Performance (SSCP) for medical devices. • Summary of Safety and Performance (SSP) for In Vitro Diagnostics (IVDs). • Summary of Product Characteristics (SPC/SmPC) for pharmaceuticals. • Creation of professional manuscripts for scientific publications, including posters and abstracts. • Adherence to reporting standards such as CONSORT (Consolidated Standards of Reporting Trials) and STROBE (Strengthening the Reporting of Observational Studies in Epidemiology). • Drafting of Lay Summaries, which provide a summary of study results specifically for laypersons. • Provision of training services located either at the client's location or at the NSF academy in Hamburg.
Post-Market Surveillance (PMS) and Vigilance
• Management of post-market surveillance (PMS) and Vigilanz for medical devices and medicinal products. • The necessity of a robust PMS system is emphasized to enable: • Early identification of market trends. • Pragmatic addressing of risks. • Continuous improvement of the product while in the market. • Integration of PMS data back into the company to prevent information from being "lost in translation." • Transitioning trend analysis from a "gut feeling" approach to a comprehensible, solid methodology.
Quality Management (QMS) and Technical Documentation
• Creation of high-quality technical documents in accordance with legal requirements for medical devices and pharmaceuticals. • Optimization and auditing of Quality Management Systems (QMS) according to applicable standards and regulations. • Focus on resolving interface problems within the QMS. • Preparedness for audits to ensure high performance. • Implementation of comprehensible methodology for the evaluation of suppliers, moving away from subjective assessments. • An efficient QMS is described as the foundation for: • Loyal customers. • Motivated employees. • Strong products that facilitate business growth.
Regulatory Affairs, Design, and Development
• Support with clinical studies and clinical evidence required for the approval of medical devices and medicinal products. • Infrastructure for Regulatory Affairs: • Expertise in regulatory requirements and compliance standards for medical devices and pharmaceuticals. • Infrastructure for Design & Development: • Expertise in normative and regulatory aspects of product development within medical technology.
Consulting and Diagnostic Inquiries
During the consulting process, several critical pain points are identified through targeted questions: • Delegation of Effort: Does clinical evaluation require significant effort that the client would like to delegate? • Workload Management: Is the team buried under a mountain of reports regarding safety and performance? • Planning Uncertainty: Is there uncertainty regarding the planning required to set up a clinical study? • Market Access: Requirement for solid clinical evidence to secure market access for products. • Reporting Overload: Does the writing of mandatory reports take an overhand position in the company's daily operations? • Trend Analysis methodology: Is the trend analysis based on gut feeling rather than a comprehensible methodology? • Feedback Loops: Is valuable market information from PMS data being lost when fed back into the company?