Case Study: Celegence Deploys Centre of Excellence Model to Streamline Regulatory Activities
Tackling Regulatory Activities
A global biopharmaceutical company headquartered in France wanted to streamline operations for its regulatory affairs activities, including xEVMPD submissions, document formatting, publishing and submissions to health authorities, and RIMS data collection and management.
To achieve these objectives, the company needed to overcome several challenges. First, its limited internal resources were required to manage regulatory, pharmacovigilance and medical affairs activities. A second big issue was that of consistency, both in terms of RIMS data and in terms of MS-Word templates for dossier submissions. A third big challenge for the company was addressing the competing priorities between regulatory data management and regulatory operations in terms of pre-submission, submission and post-submission activities.
Key Objectives: Streamline Regulatory
To address these many challenges, the company sought a single vendor partner to support it in all key regulatory activities. Specifically, the company wanted its partner to managing document level and submission level publishing, handle its xEVMPD submissions backlog and carry out ongoing maintenance, and create RIMS forms to streamline data management from local affiliates.
The company had several key objectives, including to realize efficient and harmonized processes; reduce the time and effort required by core RA team members to manage IT tools and environments; integrate the different tools and processes used; accelerate the submission process; reduce operational cost; and meet quality and compliance requirements.
To achieve these objectives, the company turned to Celegence as an extension of its own internal regulatory affairs team. Specifically, the team was contracted to:
Manage the xEVMPD backlog and ongoing maintenance through client’s preferred method (EVweb)
Tackle document-level formatting per customer in-house specification, with Celegence using its own IT tools and processes for document and PDF publishing activities as per regulatory requirements. All formatting and publishing was supported through Celegence’s Business-Process-as-a-Service capabilities.
Deliver data quality improvement in the RIMS solution and creation of an enhanced structure proposed after an assessment report
Conduct RIMS data cleansing per the current registrations and required field updates
Enable robust performance monitoring and control through transparent KPI & SLA dashboards
Celegence Solution & Approach:
The biopharma client chose Celegence and its Center of Excellence (CoE) working model was contracted to act as an extended arm of its internal regulatory affairs team. The use of the CoE model allowed for integrated teams to be built, creating synergies between various regulatory activities.
The Celegence team first sought to understand the current processes through multiple workshops on the different operational areas. The workshop helped the team to 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 to identify gaps in each area and to 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.
Key Project Achievements:
The Celegence Difference
Across all RA activities, Celegence helped the client achieve its objectives and improve processes. To start with, standard formatting instructions were developed for consistency in dossier submissions, including look and feel aspects of the documents. This helped to ensure that every submission would be successful with minimum rework required in the future.
The Celegence team also established a roadmap for RIMS data collection from local affiliates, expanding overall process to cover global regions and business units. This has helped to ensure consistency in how RIMS data is collected across all markets.
To ensure xEVMPD compliance was achieved, Celegence first addressed the backlog and then committed experienced resources to manage ongoing submissions.
Celegence has put in place an experienced eCTD publishing team to manage publishing, submission and archival activities for various regions, thereby reducing burden of the client’s internal resources.
Realizing the long-term value with Celegence’s CoE model
Through its CoE working model, Celegence has delivered measurable improvements and outcomes to the biopharma client. These include:
- Performance measurement through KPIs combined with budget control
Process consultancy and operational improvements for the overall program, leading to overall time reduction for operations by 50%
100% quality & timeline delivery performance despite tight timelines, an achievement that would not have been possible without Celegence’s expertise
Reduction in total cost of ownership including resources, tools and other operational cost
Improved compliance based on guidance from Celegence’s regulatory experts
Key to the success of the partnership was the time committed to understanding goals and objectives through detailed workshops. This helped to 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.