Medical Consultant

The contractor will receive all necessary documents, guidelines, accesses, and information required to deliver the service in advance by BI. The service will be provided independently by the contractor, based on the contractor’s expertise and experience, which consists of the following tasks:

Professional consulting regarding the creation of decision logic:

- Identification of critical patient parameters necessary for the definition of treatment recommendation based on medically relevant patient information and data available in the EHRs

- Definition of decision logics (IF/THEN rules) for treatment recommendations based on the chosen guidelines and prescribing information, reporting and communicating those to the development team who will implement those rules as central algorithms of Exandra

- Documenting the rationale for the defined rules and providing it to BI

- Designing the strategy for rule definition for borderline/ambiguous cases and documenting the rationale behind the defined rules

- Defining the individual rules interact (priorities, hit policy)

- Defining additional medically relevant medical user information to be included in the tool

- Documenting the sources/references of information included in the tool

- Identification of potential clinical risks and their mitigations during the lifecycle of the software

Validation of decision logic:

- Consulting regarding the definition of a protocol and analysis plan for the validation of accuracy, safety, and performance of the software for the current software and its updated versions (when new guidelines are published)

- Definition of patient test cases for the validation study

- Validation of the defined decision logic with several experts/societies to reduce bias and improve accuracy

- Professional consulting regarding the local KOL network to be involved in the evidence-generation activities, including the clinical validation

- Professional consulting in the definition of key performance indicators/ outcome measures for the validation process based on the contractor's expertise.

- Providing materials for the Medical Legal Review (MLR) approval process for the prototype / SaMD product which aims to evaluate the system’s content from the medical accuracy and legal standpoint before launch. This task will include a compilation of screenshots of all the features of the application, logic rationale, validation results, and related materials to present the tool to the MLR board

Iterate and Learn:

- Professional consulting regarding the local clinical practice guidelines and the German healthcare system

- Keeping track of updates in the scientific literature and adverse events databases of similar products (guidelines, product monographs, and local regulatory changes) assesses whether the tool is safe, performs as intended, and that it is up-to-date.

- Providing professional consulting with peer-reviewed publications and other scientific activities owed by the Evidence Team (e.g., literature research)

- Provide professional consulting with the development of clinical evaluation plan and report before and after the market phase

- Communicating with the local country teams, experts, and societies

- Communicating with the UX team and oversight of research activities from the medical standpoint

- Analysis of medical feedback from users to identify product updates and improvements, and document required changes

- Communicating in project-specific meetings with the technical team regarding improvement/refinement/extension of the decision support algorithm/logic, responding to medical queries from the technical team