Clinical Research Organization - CRO / Clinical Affairs

We ensure the qualifications and expertise relevant for you to carry out the clinical evaluation:

  • Analysis of the degree of innovation and relevant clinical risks of your products,
  • Feasibility studies prior to product development,
  • Identification and evaluation of equivalent products (in accordance with MDCG 2020-5) – also for 510(k) procedures at the FDA,
  • Preparation of all relevant documents of a clinical evaluation: Clinical Evaluation Plan (CEP), literature search protocol, literature search report, Clinical Evaluation Report (CER),
  • Conducting the clinical evaluation in accordance with the formal requirements of the MDR and MEDDEV 2.7/1 Revision 4,
  • Scientific literature search on the planned clinical application (indication/prevalence/state of the art in therapy and diagnosis/alternative treatment options),
  • Scientific literature search on equivalent products and relevant, similar products,
  • Assessment of the relevance (PICO) and methodological quality of the clinical data obtained,
  • Recording and evaluation of post-market surveillance data (PMS),
  • Sound advice on the need for a clinical trial, development of the general clinical strategy of the clinical evaluation, tailored to your product, and
  • Analysis of the data and assessment of compliance with the essential requirements (safety, performance, benefit/risk, side effects).

Our experienced CRO consultants will organize and support you:

  • Formulation of the objectives and hypotheses of a clinical trial / study in accordance with EN ISO 14155,
  • Conducting various types of studies (First-in-Man – FIM, Investigator Initiated Trial -IIT, pilot studies, Investigational Device Exemption – IDE, pivotal studies, reimbursement studies, Post Market Clinical Follow-Up Study – PMCF, etc.),
  • Preparation of the necessary technical (minimum) documentation,
  • Definition of test location and interfaces,
  • Drafting of contracts and organization of insurance transactions,
  • Obtaining initial approval for the clinical trial,
  • Project management of the clinical trial including budget management,
  • Continuous monitoring, support and coordination of interfaces,
  • Ensuring test documentation, data management and data protection,
  • Monitoring compliance with regulatory requirements,
  • Evaluation of data from clinical trials according to statistical, biometric and other aspects,
  • Preparation or review of the audit report and
  • Medical writing including relevant data, regulatory requirements and current formats.

We provide proof of the safety and benefits of your medical device:

  • Carrying out the annual market observation activities,
  • Analysis of the clinical evaluation, the risk management file and the usability engineering file to ensure they are up to date,
  • Assessment of incidents, Field Safety Notifications (FSN), Field Safety Corrective Actions (FSCAs), complaints for relevance to your product and subsequently for your Post Market Surveillance assessment,
  • Preparation of Field Safety Notice (FSN) plan and Field Safety Corrective Action (FSCA) plan (Article 89 of the MDR),
  • Preparation and maintenance of the post-market surveillance plan in accordance with Article 84 and Annex III of the MDR,
  • Preparation and maintenance of the post-market surveillance report in accordance with Article 85 of the MDR,
  • Preparation and maintenance of the safety report (“PSUR”) in accordance with Article 86 of the MDR,
  • Preparation and maintenance of the Summary of Safety and Clinical Performance (“SSCP”) in accordance with Article 32 of the MDR,
  • Preparation and maintenance of the post-marketing clinical follow-up plan/report (“PMCF plan/report”) according to Annex XIV Part B of the MDR and according to the requirements of MDCGs 2020-7 and 2020-8,
  • Scientific literature search as a continuation of the clinical evaluation regarding new findings from the literature and in view of safety and benefit for the product to be evaluated,
  • Research on current guidelines of professional societies and safety reports in official databases on equivalent and relevant, similar products,
  • Risk assessment with regard to reported incidents and
  • Support in deciding on the necessity of post-market clinical follow-up studies.

We ensure the qualifications and expertise relevant for you to carry out the performance evaluation:

  • Analysis of the degree of innovation and relevant risks of your products,
  • Feasibility studies prior to product development,
  • Preparation of a performance evaluation plan and a strategy for market approval,
  • Performance evaluation according to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and MDGC 2022-2 including preparation of the performance evaluation report (PER),
  • Scientific literature search on the planned in-vitro diagnostic application (indication / prevalence / state of the art in therapy and diagnosis),
  • Scientific literature search on the scientific validity of the analyte and clinical performance of the product to be evaluated,
  • Scientific literature search on equivalent products and similar products,
  • Evaluation of the relevance and methodological quality of the performance data obtained,
  • Recording and evaluation of post-market surveillance data,
  • Sound advice on the need for a performance evaluation study, and
  • Analysis of the data and assessment of compliance with the essential requirements (safety, performance, benefit/risk, side effects).

We provide proof of the safety and benefits of your in-vitro diagnostics product:

  • Carrying out the annual market observation including monitoring of the schedule,
  • Analysis of the performance evaluation, the risk management file and the usability engineering file for up-to-dateness,
  • Collection, evaluation and reporting of incidents,
  • Preparation of Field Safety Notice (FSN) plan, Field Safety Corrective Action (FSCA) plan (Article 82 IVDR),
  • Post-market surveillance plan and report in accordance with Articles 79 and 80 IVDR,
  • Preparation and maintenance of the safety report (“PSUR”) Article 81 IVDR,
  • Scientific literature search as a continuation of the performance evaluation regarding new findings from the literature and in view of safety and benefits for the product to be evaluated,
  • Research on current guidelines from professional associations and information from authorities,
  • Analysis of product incidents reported to the manufacturer and of comparator products in accordance with Article 84 IVDR,
  • Market observation research via international databases,
  • Risk assessment with regard to reported incidents and
  • Support in deciding on the necessity of post-market performance follow-up studies.