Centre of Excellence Model to Streamline Nonclinical Data Processing and Presentation in Contributor Reports

Project Summary

A global biopharmaceutical company headquartered in San Francisco wanted to advance and streamline operations for its gene therapy program, including preparations of different types of reports but not limited to developmental, analytical, contributor reports and creation of in-house standard operating procedures (SOP).

Celegence Solution & Approach:

The biopharma client chose Celegence and its Center of Excellence (CoE) working model as the use of the CoE model allowed for integrated teams to be built, creating synergies between various non-clinical project activities. CASE I: The report template evolved as the customer’s team grew and new studies were performed. During the development of the first report from scratch, Celegence and the customer uncovered issues with their data. It required a different approach to reprocess the data. To help facilitate the issue, Celegence offered to help with the data and created a processing tool. In addition, a standard was developed based on known industry standards for data table presentation. For sample re-analysis, Celegence provided an acceptable framework for reporting the original and reprocessed data sets in a single report. CASE I: The report template evolved as the customer’s team grew and new studies were performed. During the development of the first report from scratch, Celegence and the customer uncovered issues with their data. It required a different approach to reprocess the data. To help facilitate the issue, Celegence offered to help with the data and created a processing tool. In addition, a standard was developed based on known industry standards for data table presentation. For sample re-analysis, Celegence provided an acceptable framework for reporting the original and reprocessed data sets in a single report. CASE II: In another case, a third-party vendor provided the results of their lab work, partly in the form of a large number of proprietary images in an unusable format. Celegence extended the support to address the issue and promptly located proprietary tools for the initial processing of the images. Celegence developed a method for processing many of the images into report-ready files with minimal loss of resolution. This saved the customer a great deal of time preparing the images for inclusion in the report.

Highlights:

The Celegence team first understood the current processes through multiple workshops in the different operational areas. The workshop helped the team develop an analysis of current vs desired outcomes and processes.

Discussion focused on Standard Operating Procedures (SOPs), Work Instructions (WI), and IT tools for performing activities related to various processes as well as roles and responsibilities of the resources. This analysis helped identify gaps in each area and establish the optimized processes, tools and roles. Subsequently, a proof-of-concept was conducted for each process area to evaluate the effectiveness of the newly enhanced processes.