Competence Area

Clinical Affairs

Developing and implementing clinical strategies is the starting point for every go-to-market strategy. Pre-market submission is a critical corner stone in every product strategy. Throughout the pre-market stage lots of different departments, processes and documentation needs to be aligned. A very time consuming and resource intense task.   

lexoro’s Intelligent-Automation tools help to accelerate this phase. We can automate time consuming tasks and integrate data from multiple sources into pre-defined application forms.

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Benefits of Intelligent Automation in Clinical Affairs

lexoro can support your Clinical Affairs team along all relevant tasks and responsibilities. We offer end-to-end support in the area of clinical trials and related studies. We free you from routine work and give you tools to monitor and manage the full project cycle.

  • Automate the generation of regulatory documents (SOPs, CER)
  • Automate the process of investigational device exemption (IDE)
  • Automate the generation of study protocols
  • Automate the process of data gathering, data cleaning and case report form generation (CRF)
  • Pre-Classify study reviews 
  • Automate the literature review process
  • Generate dossiers and single study reports on research findings
  • Generate Marketing dossiers
  • Automate the generation of the Clinical Study Report (CSP)
  • Automation of documents for in vitro diagnostic medical devices ((EU) 2017/746)
  • Writing of clinical study reports (GCP)
  • Automation of medical writing (ISO 14155)
  • Automation of the evaluation of the biocompatibility of medical devices (ISO 10993)
  • Automation of Clinical Evaluation Plans (CEP)
  • Automation of Clinical Evaluation Reports (CER)

Cost reduction

Quality increase

Relief for employees

Experts focused on their activities

Standardization of processes

Increase productivity

Get rid of routine work?

Lets talk about it. Our Solution Experts can give you further insight into Intelligent Automation options along the entire Compliance-Chain.

Let BOTs and A.I. help you in time consuming tasks and refocus your time on real quality work.

Tell us about your wildest automation wishes – and we turn them into reality!

Your contact person

Michael Fischbäck

Business Development Consultant

Sign up today for your initial Brainstorming.

Intelligent Automation along the entire Compliance-Chain

We enable all critical areas of the value chain with automated solutions. All regulatory workflows, tasks, documents and forms can be integrated into a highly automated suite. Check out your specific area of interest and get inspired by concrete use-cases we delivered to our clients in the MedTech, Pharmaceutical and Chemical industries.