Case Study: CER Writing Support: Clinical Evaluation of Clinical Decision Support Software

Background – Client Needs:

A leading pharmaceutical company required support for authoring EU MDR compliant Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER) and Post-Market Clinical Follow-up (PMCF) Plan for initial CE-marking of a Class IIa medical device software (MDSW).

The software is intended for use by Healthcare Provider (HCPs) in clinical practice to assist in monitoring the risk of progression from relapsing-remitting multiple sclerosis (RRMS) to secondary progressive multiple sclerosis (SPMS), thereby facilitating physician–patient interaction and aiding in clinical decision-making related to disease progression.

Project Initiation & Key Objectives:

The scope of the work for Celegence involved creating end-to-end EU-MDR compliant clinical evaluation documents and addressing Notified Body (NB) observations on the documents submitted for review.

Celegence Solution & Approach:

Celegence team provided medical writing and regulatory consultation services through the entire process of NB review.

This included:

  • Comprehensive literature review for the medical device and the State-of-the-Art
  • Evaluation of non-clinical and clinical data generated and held by the manufacturer
  • Real-world evidence from adverse event databases
  • Robust analysis of the safety, performance, and benefit-risk profile of the devices to demonstrate conformity to General Safety and Performance Requirements outlined in the EU MDR.

Project Achievements

Celegence addressed two rounds of observations and provided detailed responses to queries from the NB. The customer appreciated the support provided by Celegence and the adaptability of the team.

Project Outcomes

The Celegence’s end-to end document writing process and involving right stake holders lead to high quality clinical documentation achieving:

  • >98% quality & timeline delivery performance despite tight timelines
  • Improved regulatory complaint documents based on guidance of Celegence’s regulatory experts

Key to success of this partnership was a highly adaptable team of writers who worked in tandem with the client’s team and experts who understood the gaps in the documents queries from the NB reviewers.

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