Company insight
The challenges in effective vendor management
The growing complexity of clinical trials is a major challenge for midsize and small enterprises (sponsors) in the biopharmaceutical and medical device industry. However, as Lumis Life Science Consulting outlines, a partnership with an effective risk-based vendor management system can result in mitigated risks, increased efficiency and cost savings.
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ften with limited financial resources, midsize and small companies need to plan effective clinical trial programs with appropriate vendor and oversight management. Stakeholders need to be satisfied while maintaining the highest quality to ensure patient safety, data integrity and eventually generating outcomes and evidence for post- marketing positioning and reimbursement strategies. In parallel, new regulations and guidance require clinical research stakeholders to continuously implement and adapt their processes. According to ICH-GCP E6, the sponsor remains ultimately responsible for the quality and integrity of a study. In ICH-GCP E6 R2, the sponsor’s oversight is not just limited to the contracted vendors, but also requires responsibility over the vendor’s third parties and subcontractors. Small sponsor companies depend heavily on outsourcing their clinical trial activities due to limited resources. Their success is directly related to their vendor management approach; how they manage their vendors successfully to ensure quality data and patient safety. The most effective approach to risk-based vendor management is the implementation of a risk-based vendor management system. This identifies, assesses, reviews and control any risks, defining risk-mitigation strategies and monitoring the outcome.
What is required for effective vendor management? The main goals of a successful vendor management are quality, budget and time optimisation to meet the company’s business objectives. Sponsors expect to gain increased value through their vendors throughout the existing contract life cycle.
Clinical Trials Insight /
www.worldpharmaceuticals.net
A vendor management plan and an effective risk mitigation strategy that best fits the sponsor organisation should be implemented at the start of the outsourcing activities.
Select the ‘right’ vendor As a sponsor company, it is critically important to define the objectives and goals of the outsourced activity and to assign a team that is responsible for the selection process with the required experience and competencies. The use of standardised vendor selection tools should build the ground for the selection of the service provider. The performance of a qualification audit is essential to confirm the vendor has implemented the required quality management system, established processes and possess the qualified resources and experience to operationalise the clinical trial.
Risk management
A governance plan as part of the contract details the work relationship between sponsor and vendor, their organisational structure and the roles and responsibilities of the corresponding project team members. Decision making processes at different levels of the project organisation, as well as escalation procedures, are also defined in the governance plan. Having a clear communication line and flow at each level is important for the cooperation between sponsor and vendor.
Vendor performance measurement The sponsor should define what is the most critical aspect for the clinical trial and for its business overall. Performance measurement is an ongoing activity that needs to be defined at the beginning of the study (contract stage) in agreement with the
vendor, and should be monitored and fine-tuned during the ongoing study. Defining key performance indicators (KPIs) is crucial to measure the vendor performance. The review of KPIs has to be done regularly and deviations need to be assessed, addressed and, if applicable, corrective and preventive actions (CAPA) implemented. It is advisable to focus on KPIs that have the highest impact on the study outcome and company success.
Relationship management Vendors and sponsors need to develop their relationship throughout their contract lifetime. This relationship is fostered upon trust and communication as it is important to understand each other's goals and expectations, decision making processes, values and philosophies. Any potential misunderstandings and challenges can be avoided through regular communication, pro-actively addressing any issues with suggestions and in the spirit of a team effort between vendor and sponsor stakeholders. Implementing effective vendor management during the early stages of a project is paramount to successfully manage not only the vendor, but also for the overall oversight of a clinical trial.
Risk reduction of poor performance can be anticipated at early stages of a project as the use of transparent vendor management tools will lead to continuous improvement. Establishing a long-term relationship that fosters open communication and trust building with vendors can result in a more effective relationship management, operational efficiencies and cost savings. ●
www.lumisconsult.com/lumis-life- science-consulting
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