As sponsors require higher throughput, managers are forced to do more with the same or fewer resources, which causes a strain in scientific depth. This pressure increases as the complexities of therapeutic targets and technologies increase. Beyond that, sponsors are also seeking faster turnaround times from planning and study start to reporting and data transfer. However, many sponsors don’t realize the benefits of bundling services, which can lead to cost savings and operational efficiencies.
The Business Case for Integrating Testing Services
A recent market research study analyzed the current needs of Bioanalytical (BioA) decision-makers from a wide range of pharmaceutical companies around the world. This study found that 70% of respondents cited quality, capacity and efficiencies as top factors influencing the selection of a clinical BioA laboratory partner.1 Integrating BioA testing with Central Laboratory Services (CLS) outsourcing can reduce development time by leveraging operational efficiency and available capacity. Quality data sources can also be integrated to inform decisions, leading to faster development of plan designs and clinical study protocols. While increasing efficiency is important, research shows that sponsors are combining clinical BioA with CLS less than 15% of the time.
The following two scenarios will examine the cost of managing multiple BioA labs and the efficiencies of integrating clinical BioA and central laboratory testing.
Using Multiple BioA Laboratories
In this example, a large pharmaceutical company (sponsor) contracts with seven BioA laboratories for clinical testing, conducts 50 clinical studies and processes 60,000 BioA samples per year with their central laboratory service provider. On average, 70% of these samples are distributed among the seven BioA laboratories.
In a typical outsourcing model, the sponsor starts by selecting their laboratory partners using requirements outlined in the RFP process to determine feasibility, testing capabilities, general testing information and pricing for each clinical protocol or project. Next, labs are qualified and contracted via a quality assurance audit and master services agreement. At this point, the average sponsor will have invested roughly $600,000/year in internal resource utilization to support management of multiple laboratory partners.
Following laboratory selection and contracting, the sponsor works with each lab on setup and validation – test specifications and study setup with the sponsor’s project management team. Study execution, which includes sample transportation to each BioA laboratory, weekly reconciling of data, checks on turnaround time (TAT) plus lab data integration, may cost the sponsor more than $1.2M/year when utilizing multiple laboratories.
Additional required monitoring activities such as evaluating lab performance – including TAT and testing issues through monthly monitoring calls/emails – may cost the sponsor another $240,000/year. Therefore, the total cost of evaluation, set-up and management of multiple laboratory vendors could be more than $2M/year.
Efficiencies from Bundling BioA and CLS
Integrating clinical BioA and CLS testing using a single provider provides efficiencies. A single outsourcing partner translates to less duplication of tasks during vendor qualification and contracting. In addition, having a single budget and multi-unit master services agreement that covers legal, business and operational terms, as well as a single invoice aligned with your milestones, also saves management time throughout a project.
Following method development, the BioA and CLS teams can jointly discuss the risks of using sample information from the method development to set up the clinical database and kit design. When appropriate, the joint team can use the sample information from the method development for the BioA method validation to take place in parallel with the development of the statement of work (SOW) and test kit design. This facilitates test kits being ready for production and shipping up to 35% earlier than would otherwise be possible.
Additional streamlining can be seen in the SOW design between BioA and the CLS database, reducing systems limitations and future SOW amendments. A single partner for both BioA and CLS can also mean protocol amendments can be handled directly through one internal process to expedite communication and faster implementation of the amendments within BioA. Additional communication efficiencies can be realized, including: planning of shipments, addressing sample discrepancies and reconciliation activities.
Finally, a single partner for both BioA and CLS means that BioA data can be integrated directly into the CLS database, requiring only one data transfer specification and one set of reconciliation activities that cover both BioA and CLS simultaneously. This saves time and, ultimately, expense during the setup phase and requires fewer personnel hours for data lock.
The Bottom Line
Sponsors can gain strategic efficiencies by integrating clinical BioA and CLS testing – streamlining contract and budget management, increasing data delivery speed, reducing sample demographic discrepancies and eliminating lab-to-lab transfers. Coupling clinical BioA and CLS with a single provider can also decrease the time it takes to ship kits, resulting in faster data lock and milestone achievement.