Charles River Laboratories recently launched RightSource, a new insourcing/outsourcing option to pharma and biopharma companies that allows them to completely externalize their quality control (QC) testing program to Charles River. As part of the service, Charles River and the client identify the best combination of insourcing and outsourcing options, and Charles River then manages all aspects of the client’s QC testing program, evaluating and selecting outsourcing vendors where necessary, and providing a dedicated project manager familiar with the technical aspects of the program to oversee all of the client’s QC activities.
We spoke with Birgit Girshick, corporate senior vice president, Research Models and Global Biopharmaceutical Services, at Charles River to find out what was behind the offering, where the demand for these services lies, and how the service works. – KB
Contract Pharma: What were some of the driving factors behind establishing the new service?
Birgit Girshick: Pharmaceutical and biotech companies are looking to improve efficiencies and reduce costs, an effort made more difficult by their various facility locations, robust staff, and numerous stakeholders. Charles River saw demand for RightSource since, more and more, clients are aiming to promote efficiency through strategic sourcing initiatives, closer collaboration with contractors and increased externalization.
Many pharmaceutical companies currently work with a large number of insourcing and outsourcing service providers, but are looking to consolidate vendors due to challenges, such as the large number of quality audits required, shipment logistics, lack of control over timelines, incompatibility with various systems, and an inherent difficulty managing numerous outside vendors. Charles River’s RightSource aims to streamline the entire process.
CP: From what sector/s do you see an increase in demand for these services?
BG: We are seeing an increased demand from mid to large-sized pharmaceutical and biotech companies, particularly those companies currently performing their quality control testing in house.
CP: What specialized services are offered as part of the RightSource service?
BG: RightSource offers introductory consultations, a dedicated project management staff, and on-going counsel. Charles River provides a full-time change agent that will, together with the customer’s stakeholders, evaluate each case for externalization and recommend the best approach. This change agent, or RightSource Team Leader, will be responsible for performing or coordinating the evaluation, working with the customer’s stakeholders, providing a written benefit/cost proposal and presenting to the customer’s leadership team.
A dedicated, experienced project management staff will oversee the program, but can work on or off-site to manage all QC testing performed in-house or outsourced. They will also provide weekly status updates to stakeholders, plan and forecast all QC testing needs, coordinate shipping and associated paperwork, input information into your LIMS systems, research outsourcing options for services not provided by Charles River, manage other outsourcing partners, and handle invoicing and financial forecasting.
Lastly, RightSource offers an on-going review and presentation of key performance indicators leading to a metrics-based evaluation of processes to increase performance, quality, service and compliance as the program moves forward.
CP: Are these services associated with partnerships? Do you have specific vendors you work with?
BG: Charles River’s long-standing experience with operating quality control testing laboratories in various countries, for thousands of clients in all areas of scientific disciplines, allows us to be able to drive efficiencies and find cost savings for companies. We have partner companies that we might draw from, but will also look beyond our current partners to find the best company for the customer’s needs and then manage the partnership for them. This also might include vendors that the company already considers a partner.
Kristin Brooks has been the associate editor at Contract Pharma since 2004.