Case Study: 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).
The Client Faced the Following Challenges:
The company had to overcome several challenges, such as:
Project Initiation & Key Objectives:
To address these challenges, the company sought a partner to support all their key non-clinical report writing activities. Specifically, the company wanted its partner to manage reports with high quality that comply with good document practice and applicable health and safety guidelines and authorities.
The company had several key objectives, including realizing efficient and harmonized processes; reducing the time and effort required by core team members to manage the cloud file-sharing environments, IT tools, and environments; granting the different tools and processes used in their lab experiments; accelerating the submission process; reducing operational cost, and meet quality and compliance requirements.
To achieve these objectives, the company turned to Celegence as an extension of its own internal nonclinical writing team. Specifically, the team was contracted to:
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 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.
Approach:
Solution:
QC Tables/Other Data processing: Celegence created a template for compiled calibration standards and QC sample data tables supporting the customer’s gene therapy program. This involved pulling data from each plate and into one table for each gDNA. Inter-plate statistics were also included. These tables continue to be used for all reports and have reduced the time customers need to prepare their data for inclusion in the report.
Celegence created a data table template for the repeat analysis of study samples. This was done based on Celegence’s deep report writing experience in regulated bioanalytical analyses. The template has remained in use for all subsequent studies.
A data processing tool was created to help customers process their raw data into reportable values. The tool also informed the user if the raw data fell above or below established thresholds. The user also had the flexibility to modify the thresholds. Should the change in thresholds affect individual sample results, the user is automatically informed by the tool. Celegence’s nonclinical writing consultant had the industry knowledge and experience to create this tool for the customer.
Celegence’s nonclinical writing consultant worked with the customer to edit and format many ultra-high-resolution images. Celegence located the proprietary software and quickly learned to render the images into formats that were more easily accessible to more commercially available software. The images were made into report-ready representations of the immunohistochemistry results generated by a third-party laboratory. These images were ultimately compiled with other images for inclusion in the report.
Project Achievements – The Celegence Difference
Across all RA activities, Celegence helped the client achieve its objectives and improve processes. A plan was promptly developed, and the lead consultant worked with the customer to create a report template. To achieve the Right First Time (RFT) approach, a QC checklist and standard formatting instructions were developed to maintain consistency across various reports, including the look and feel aspects of the documents. This helped to ensure that every document would be of top-notch quality and successful with minimum rework required in the future.
Celegence has put in place a team of industry experts with deep nonclinical bioanalytical report-writing and data processing experience, thereby reducing the client’s internal resources burden.
The Celegence team also established a roadmap for overall report development activity. This has helped to ensure consistency in how document workflow is managed over the period of report development activity.
Realizing the long-term value of Celegence’s CoE model
Through its CoE working model, Celegence has delivered measurable improvements and outcomes to the biopharma client. These include:
- 1Performance measurement through KPIs combined with budget control
- 2Process consultancy and operational improvements for the overall program, leading to overall time reduction for operations by 50%
- 3100% compliance to quality and timeline delivery performance despite tight timelines, an achievement that would not have been possible without Celegence’s expertise
- 4Reduction in the total cost of ownership, including resources, tools and other operational costs
- 5Improved compliance based on guidance from Celegence’s regulatory experts
- 6Well-established communication and governance structure with open and transparent discussions
Project Success:
The success of the partnership was due to the time committed to understanding goals and objectives through detailed workshops. This helped set the tone for the project and ensure quality outcomes from the delivery team. Furthermore, having a common understanding of requirements resulted in faster turnaround time and zero errors.
Celegence’s global medical writing specialists are experts in the multiple therapeutic areas and product types, with in-depth knowledge of regulatory, clinical, and scientific contents perfectly integrated with technical, editorial and quality control capabilities. Our medical writers are well versed in working with various stakeholders such as clinical operations, data management, biostatistics, medical and safety teams.
