With the implementation of the new Medical Device Regulation (MDR 2017/745/EU) now delayed by Covid-19 until May 2021, the planning and implementation of clinical investigations remains a major challenge, especially for small and midsize medical device enterprises (sponsors). With the soon-to-come revision of the ISO/FDIS 14155:2019, the alignment between ICH-GCP and ISO 14155 will result in further complexity of the clinical investigations of medical devices to ensure patient safety and data integrity. With often-limited financial resources, small and midsize companies need to plan effective clinical investigations of their medical devices.
Small sponsor companies depend heavily on outsourcing their clinical trial activities due to limited resources, specific knowledge and/or missing infrastructure to perform clinical investigations on their own. Their success is directly related to their vendor management approach and how they manage their vendors successfully to ensure the data quality and patient safety.
The implementation of a risk-based vendor management system through identifying, assessing, reviewing and control of risks, defining risk-mitigation strategies and monitoring the outcome, is the most effective approach to vendor management.
The main goals of a successful vendor management are quality, costs and time optimisation to meet the company business objectives. Sponsors expect to gain increased value through their vendors throughout the existing contract life cycle. 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 vendors
Each clinical investigation has different needs to be fulfilled. As a sponsor company, it is critically important to define the objectives and goals of the outsourced activity, and to assign a team with the required experience and competencies to be responsible for the selection process. The selection of a vendor should start with a request for information (RFI) to ensure identified vendors fulfil the sponsor’s main prerequisites. These might include experience with device clinical trials, specific patient populations (such as children) or clinical evaluation plans, which require customised processes, regulatory knowledge and more. A tailored RFI sent to the preselected vendors will enable the sponsor companies to narrow down the list of vendor companies to continue the selection process with. The next step covers a well-defined request for proposal (RFP), enabling the vendors to not only provide assumptions for the services required and corresponding budget estimates, but also to demonstrate their tailor-made approach to execute the clinical investigation under discussion.
The performance of a qualification audit of the preselected vendor is essential to confirm the vendor has implemented the required quality system, and established processes, qualified resources and experience to operationalise the clinical investigation.
Vendor contract management
The final decision will be fixed with the contract. The contract should define the overall relationship and expectations. It shall outline a clear description of the services the vendor is responsible for within certain time windows (timelines) and the sponsor expectations for the conduct of the clinical investigation. Distribution of roles and responsibilities, performance measures, regular reviews of the work process, payment schedules and a clearly defined governance model should be an integral part of the contract. It is recommended to carry out a regular review of the agreed terms concerning the delivered performance throughout the clinical investigation. The regular review should be a joint effort between sponsor and vendor to drive project improvement.
Vendor management
The service provided by the vendor needs to be closely monitored and managed by the sponsor. A governance plan can help to define the 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.
Clear communication lines and flow at each level of the teams is important for cooperation between sponsor and vendor.
Vendor performance measurement
The sponsor should define what is the most critical aspect for the clinical investigation under discussion, and its overall business. Performance measurement is an ongoing activity and needs to be defined at the beginning of the study (contract stage) in agreement with the vendor, monitored and fine-tuned during the relationship.
The metrics and key performance indicators (KPIs) might differ between vendors and service activities. To start with, it is necessary to agree on what should be measured and the acceptable level of vendor performance. The review of the vendor performance has to be done regularly and deviations need to be assessed, addressed and, if applicable, have corrective and preventive actions (CAPAs) implemented.
Relationship management
Vendors and sponsors need to develop their relationship throughout the contract lifetime fostered upon trust and communication. Trust is the basic condition for each successful cooperation and the most sensitive part of the relationship. It can take a long time to be built, but it can be conversely destroyed within a very short time. Sponsor and vendor need to understand each other, their corresponding goals and expectations in the relationship; and understand their different organisations, decision-making processes, values and philosophies. The better they understand each other, the faster trust can be built. Potential misunderstandings and challenges can be avoided through regular communication and proactively addressing any issues with suggestions and in spirit of a team effort encompassing vendor and sponsor stakeholders.
Open and transparent communication is an essential tool to mitigate risks in the vendor management process. Effective vendor management implemented at the early start of a project, is paramount to successfully manage not only the vendor but also for the overall conduct of the clinical investigation. At onset, sponsors should have a clear view about their key criteria, goals and objectives when searching a vendor to provide support on clinical investigation activities.
Establishing a long-term relationship, and fostering open communication and trust-building with vendors can result in more effective relationship management, operational efficiencies and cost savings.
At the end, the sponsor remains ultimately responsible for the patient safety, quality and data integrity of a clinical investigation.
This article was published in association with Lumis, which specialises in supporting small to midsize medical device and biopharmaceutical companies in their vendor selection, vendor management and oversight management of clinical trials. As a legal representative in Europe, the company also supports non-European sponsors when conducting clinical trials in Europe.
This article originally appeared in Volume 1, 2020, of Medical Device Developments. The full issue can be viewed here.
