avaClinical
Systematic execution and updating of clinical evaluation, scientific literature reviews, state of the art description, claim management and integration with product development, risk management, and post-market surveillance
Systematic proof for clinical evidence and consistency to interfaces
Clinical evaluation is one of the most important lifecycle processes for medical devices, especially for market access in Europe: Clinical evidence ins needed for demonstration of clinical safety and performance. This includes the collection, appraised, and analyzed in sufficient quantity and quality.
Furthermore, clinical data must be continuously collected from a variety of different sources as part of regular post-market surveillance activities ( = post-market clinical follow-up) during the marketing & sales phase.
In addition to a systematic and transparent approach according to applicable regulatory requirements from the European Medical Device Regulation (MDR) and related European guidelines, the connection and dependency of clinical evaluation information with other processes is a particular challenge – inconsistencies can quickly creep in
avaClinical was introduced in 2019 as an innovative product that allows you to carry out and document a systematic clinical evaluation digitally for the first time. The proof for sufficient clinical evidence is presented in a clear and comprehensible manner, making it easier for the authors of clinical evaluation plans and reports to prepare them in compliance with regulatory requirements. Notified bodies can find required contents according to MDCG 2020-13 more quickly, which supports the creation of the Clinical Evaluation Assessment Report (CEAR).
The product includes best practice templates e.g. for the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER) based on European regulatory requirements and extensive market experience of our medical expert team gained during the last 12 years. All templates can also be customized to your needs and individual product portfolio.
Systematic collection of required Data
Single “questions” in the CEP related to the clinical safety, clinical performance, benefits or marketing claims – which require clinical evidence – are documented in form of Clinical Evaluation Subjects. Subjects can be linked to information from other processes to visualize dependencies, e.g. for product development, risk management, or marketing materials.
Also each identified data set is documented individually and linked to the Clinical Evaluation Subject. That allows in the CER an automated creation of overview tables with a clear representation of data used as evidence for a single Clinical Evaluation Subject. With this approach you always maintain a clear overview, no matter how many data records you use. Additionally, the benefit-risk assessment in the CER can be easily reused in the Risk Management Report – this way, inconsistencies do not stand a chance.
The template for the Summary of Safety and Clinical Performance (SSCP) reflects the structure of the MDCG 2019-9 guideline and clearly addresses individual questions of the clinical evaluation.
State of the Art (SOTA)
We provide specific templates and functions for SOTA information that can be systematically collected and reviewed. Acceptance criteria for medical device performance and safety parameters can be derived which can be used as input for the CEP as well as product requirements and risk management planning.
Claim Management
A major hassle for medical device manufacturers is transparently tracking and maintaining marketing claims and related evidence for a single claim. It is not a one-off process to validate claims for a product launch, for example, since claims may need to be adjusted or even removed if post-market clinical follow-up activities result in a change to the product’s benefit and risk profile. avaClinical contains dedicated features for tracking of claims and a trace to clinical and non-clinical evidence information throughout the entire product lifecycle.
Integration of IMDRF Adverse Event Coding
Within the appraisal and analysis of data sets, you can tag single data sets with IMDRF adverse event codes, which allows later the analysis of data for post-market surveillance activities and report creation.
Clinical Evaluation Process
Digitalized planning and reporting of clinical evaluation activities:
- Best Practice Templates for documents required for the clinical evaluation process based on the European Medical Device Regulation (MDR) and relevant guidelines
- Efficient document creation through reuse of existing information and automated content visualization
- Structured and transparent documented and visualization of information
- Transparent overview of evidence without having to work with additional reference managers
Process Interfaces
- Easy reuse of information e.g. from product development, risk management or post-market surveillance for clinical evaluation documentation
- Integration of clinical evaluation information in product development, risk management, and post-market surveillance processes through creation of links between single information
- Automated created of traceability reports for the visualization of dependencies between information
Literatures reviews
- Efficient collection, appraisal and analysis of publications with automated interface to Pubmed/Pubmed Central
- Application of IMDRF adverse event coding for publication evaluation
State of the Art (SOTA)
- Systematic collection and review of SOTA information, including derivation of benchmark criteria for performance and safety parameters
Claim management
- Central management of marketing claims including planning, creation of evidence and approval for use.
- Complete traceability from planned to released claims along with a trace to clinical and non-clinical data as well as relevant marketing materials
