Following the implementation of the new medical device regulation (MDR 2017/745/EU) and the revised ISO 14155:2020, the planning and implementation of clinical investigations are a major challenge, especially for small and midsize medical device enterprises (sponsors).
With often limited financial resources, small and midsize companies need to effectively plan 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. Their success is directly related to their CRO management approach and how they manage their CROs (Contract Research Organisations) to ensure data quality and patient safety.
The implementation of a risk-based CRO management system is most effective when the potential risks are identified, assessed, reviewed, controlled and a risk mitigation strategy is defined.
The main targets of successful CRO management consists of quality, cost and time optimisation, thereby meeting the company’s business objectives. Sponsors expect to gain increased value through their CROs throughout the existing contract life cycle.
Select the ‘right’ CROs
Each clinical investigation has different requirements to be fulfilled. As a sponsor company, it is critical to define the objectives and goals of the outsourced activity, and to assign a team with the required experience and competencies responsible for the selection process. A well-defined request for proposal (RFP) enables the CROs to not only provide assumptions for the services required and corresponding budget estimates, but also to demonstrate their tailor-made approach to execute the planned clinical investigation.
CRO management
The service provided by the CRO, as defined in the contract between sponsor and CRO, needs to be closely monitored and managed by the sponsor. A governance plan can help define the work relationship between the sponsor and CRO, 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 defined escalation procedures, help to establish clear communication lines and communication flow at each level of the teams.
CRO performance measurement
The sponsor should define what the most critical aspects for the planned clinical investigation, and for its business overall, are. Performance measurement is an ongoing activity and needs to be laid out at the beginning of the study (contract stage) in agreement with the CRO and monitored and fine-tuned during the relationship. The metrics and key performance indicators (KPIs) might differ between CROs and service activities. To start with, it is necessary to agree on what should be measured and the acceptance level of the CRO performance. A regular review of the CRO performance leads to early assessments of deviations to be addressed, and, if applicable, implementation of corrective and preventive actions (CAPA). There is a tendency to ‘overmeasure’ the performance. It should be limited to no more than 20 KPIs, depending on the size of the study. Not everything that can be measured, must be measured.
Relationship management
CROs and sponsors need to develop the 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. Sponsors and CROs need to understand each other, their corresponding goals and expectations in the relationship, understand their different organisations, and their decision-making processes, values and philosophies. Potential misunderstandings and challenges can be avoided through regular communication, and proactively addressing any issues with suggestions
in spirit of a team effort that encompasses the CRO and sponsor stakeholders. Open and transparent communication is an essential tool to mitigate risks in the CRO management process.
Effective CRO management implemented at the early start of a project is paramount for successfully managing not only the CRO, but also for the overall conduct of the clinical investigation.
Ultimately, the sponsor is responsible for the patient safety, quality and data integrity of a clinical investigation.
(First appeared in Medical Device Developments 2021 April addition)
This post was written by Heike Schön. Heike is the Managing Director of Lumis and has worked in management positions in clinical research for more than 20 years. Her experience ranges from conducting national and international Phase I clinical trials all the way to registration and post‑marketing activities. She had positions within contract research organisations (CROs) and in the biotechnology industry.
Heike holds a master’s degree in psychology from Freie Universität Berlin and a master’s degree in business administration from Schiller International University. Since 2002, she has been active in the Association of Clinical Research Professionals (ACRP) where she also served as a member of the Board of Trustees and as its Chair in 2010. Heike is a regular speaker at international conferences and publishes within clinical research and medical device magazines.
