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Scientific Strategy & Clinical Writing: Literature to Final Report

Consulting
Unique Identifier: 9a41c8f9-5e9e-41de-a283-583f35c27c95

Service Description

Who Can Benefit: - Clinical Researchers: For strengthening study designs and hypotheses with a comprehensive understanding of existing literature. - Medical Product Developers: To advance the development of innovative medical solutions by integrating scientific research insights. - Academics and Healthcare Professionals: For engaging in scholarly dissemination of research, raising the profile and recognition of their work.

Key Features: - Systematic Literature Research: Conducts comprehensive, literature searches to establish the scientific foundation for clinical investigation plans, regulatory submissions, and product positioning. - Clinical Investigation Plan (CIP) Development: Authors complete, ISO 14155-compliant study plans including objectives, design, endpoints, visit schedules, and statistical considerations. - Data Management Planning: Develops detailed DMPs covering database design, data collection procedures, validation rules, coding dictionaries, and quality assurance workflows. - Biostatistical Analysis: Provides full statistical support from sample size calculation and analysis plan development through to confirmatory analysis, subgroup evaluations, and results interpretation. - Clinical Investigation Report (CIR): Produces comprehensive final study reports documenting methods, results, and conclusions in accordance with ISO 14155 and regulatory expectations. - Scientific Dissemination & Publication: Supports or leads the preparation of peer-reviewed manuscripts, conference abstracts, and strategic dissemination planning. - Product Development Guidance: Translates scientific evidence into actionable recommendations for medical product design, differentiation, and clinical positioning.

Possible Applications: - MDR Clinical Evaluation Support: Conducting systematic literature reviews and writing clinical evaluation reports (CER) to fulfill MDR Annex XIV requirements for medical device certification. - Planning Investigator-Initiated Trials: Developing robust CIPs and DMPs for academic research groups conducting clinical studies on novel sensor technologies or digital health solutions. - Regulatory Submission Documentation: Producing the complete documentation package (CIP, SAP, DMP, CIR) required for notified body review or competent authority submissions. - Biostatistical Consulting for MedTech Startups: Providing sample size calculations, endpoint selection guidance, and analysis strategies for companies designing their first clinical study. - Multi-Center Study Coordination: Harmonizing documentation, data management, and statistical reporting across multiple investigational sites. - Scientific Visibility for Industry Partners: Transforming proprietary study results into high-impact publications, raising the scientific profile of commercial innovations. - Grant Proposal Support: Strengthening research funding applications with solid literature foundations, well-designed study concepts, and credible statistical frameworks.

Who We Are: The Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS) has established the Center for Sensor Technology and Digital Medicine (CEMDIS) in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through innovative sensor technology and digital solutions. This center focuses on integrating innovative medical technologies such as wearables and robotic systems to support medical diagnostics, patient monitoring and evaluating patient-specific therapies by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the development, integration, and validation of novel health technologies, providing companies opportunities for technological advancements. For more information, visit the Fraunhofer IIS website.

Keywords: MDR Clinical Evaluation clinical trial preparation Literature Research Scientific Dissemination Clinical Writing
Offerings: Technological Solutions & Documentation Business (market readiness, monitoring, feasibility, etc.) Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Ethics & Regulatory Affairs (ethics board approval, legal requirements, ...) Scientific & Medical Communication Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support) Development of conformity evaluation standards, protocols & tools Clinical Investigation Support (coordination, design, feasibility, documentation,compliance, operations support, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)
Provider Country Germany
Published Email dhs-studien@iis.fraunhofer.de

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs - Research Questions / Hypothesis - Product or Technology Documentation / Intended Use / Use Case Description - Study Design Parameters - Targeted Regulatory Pathway - Existing Literature and/or Prior Work - Sponsor Requirements for Medical Study
Service Outputs - Structured Literature Review / State-of-the-Art Report - Clinical Investigation Plan (CIP) - Data Management Plan (DMP) - Biostatistical Analysis Plan & Execution - Clinical Investigation Report (CIR) - Publication-Ready Manuscript - Dissemination Strategy - Product Development Recommendations
Dependencies & Restrictions - Sponsor Responsibilites: The customer / SME is required to be the sponsor of the clinical study. - Detailed Documentation of IP: Without detailed and complete documentation the required regulatory conform documentation can not be drafted.
Comments - The service covers the full documentation lifecycle of a clinical investigation – from initial literature research through study planning, data management, statistical analysis, and final reporting to scientific publication. - Documents are developed in compliance with ISO 14155, MDR Annex XV, and ICH-GCP as applicable, ensuring regulatory acceptance by notified bodies and competent authorities. - Biostatistics capabilities include sample size calculations, confirmatory and exploratory analyses, interim analyses, missing data handling, and subgroup evaluations using established tools (Python). - The Data Management Plan can be directly implemented on the DPM-Research eCRF platform (see eCRF Platform Service), creating a seamless link between planning and execution. - The service can be engaged modularly (e.g., CIP only, biostatistics only, literature review only) or as a full-package engagement spanning the entire study documentation from start to finish. - Co-authorship with CEMDIS scientists can strengthen publication credibility through the Fraunhofer affiliation. - For multi-center studies, the team can support harmonized documentation across sites while maintaining a single coherent reporting framework.

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