A medical device CRO or In-Vitro Diagnostic Devices (IVD) CRO is a contract research organization (CRO) that provides support to medical device and In-Vitro Diagnostic industries in the form of research services outsourced on a contract basis. A CRO provide services as biologic assay development, commercialization, clinical development, clinical trials management, and Real world evidence.
CROs are designed to reduce costs for companies developing new medical device or In-Vitro Diagnostic Devices (IVD). They are main objective is to simplify entry into MEDTECH market, and simplify development, as the need for large MEDTECH companies to do everything ‘in house’ is now redundant. CROs also support foundations, research institutions, and universities, in addition to governmental organizations.
Many CROs such as ECLEVAR MEDTECH provide clinical-study and clinical-trial support for medical devices and IVD. However, the sponsor of the trial retains responsibility for the quality of the CRO’s work. CROs range from large, international full-service organizations to small, niche specialty groups. CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new device from its conception to FDA/ CE or UKCA marketing approval, without the device of IVD sponsor having to maintain a staff for these services.
Organizatoins who have had success in working with a particular CRO in a particular context (e.g. therapeutic area) might be tempted or encouraged to expand their engagement with that CRO into other, unrelated areas; however, caution is required as CROs are always seeking to expand their experience and success in one area cannot reliably predict success in unrelated areas that might be new to the organization.
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 defined a contract research organization (CRO), specifically pertaining to clinical trials services as: “A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.”
It further details the sponsor’s responsibilities in its good clinical practice guidelines:
Guidance from the US FDA published in 2013 also speaks to the responsibility of the sponsor to oversee work of the CRO, including the circumstance where risk-based monitoring has been delegated to the CRO. 2021 saw a major update to US FDA regulations related to providing the agency with information about CROs and how they “comply with FDA regulations”.
Sponsor may transfer any or all the duties and functions related to the clinical investigation, including monitoring, to an external organization (such as a CRO or individual contractor), but the ultimate responsibility for the quality and integrity of the clinical investigation conduct shall reside with the sponsor. The sponsor shall ensure oversight of any clinical investigation-related duties and functions.
The outsourcing of duties or functions to external organizations, including subcontractors of the sponsor’s CRO(s), shall be addressed by the sponsor in accordance with written procedures for the control of suppliers. The sponsor shall specify in writing any clinical investigation-related duty or function assumed by the external organization, retaining any clinical investigation-related duties and functions not specifically transferred to, and assumed by, the external organization. Records of transfer of duties and functions shall be maintained.
The sponsor shall be responsible for verifying the existence of and adherence to written procedures at the external organization.
All requirements in this document applying to a sponsor shall also apply to the external organization inasmuch as this organization assumes the clinical investigation-related duties and functions of the sponsor.
In reality, sponsor/CRO relationships are generally a mix of both tactical and strategic elements, depending on the internal and external needs of the partners. Tactical activities include execution of contract terms, delivery of ad hoc solutions, study-level cost and performance assessments and decisions based on cost and real-time availability. Strategic activities encompass shared decision- making, delivery of broad cross-study solutions, performance assessments, shared risk and reward structures, and decisions based on longer-term objectives.
Many sponsor/CRO interactions involve inefficiencies caused by unnecessary duplication or task sharing. In this case, the sponsor remains focused on managing studies and there is task and role ambiguity, leading to confusion, frustration and inefficiencies through redundancy. A better situation would be a more streamlined partnership, with joint responsibilities and interactions reserved for a small number of critical tasks. Here, the sponsor concentrates on managing its partners; there is task and role clarity – which fosters trust and innovation – and enhanced efficiencies and deliverables.
Shared values and objectives and a high level of trust between partners are critical success factors. Once a vision has been established, additional aspects of the partnership and operating strategy can be defined so that they build trust through a combination of integrated goals, structure, resources, processes, technology and metrics. A successful strategic outsourcing program requires willingness by both sponsor and CRO to question long-held ideas about the “right” way to do things, and meet on neutral ground to develop approaches that are demonstrably better for all parties.
In project management, there are four major areas of emphasis required to drive efficiencies between the sponsor and Medical device CRO:
Wherever ECLEVAR MEDTECH does business in the world, the fundamental values of honesty, integrity and ethical conduct form the core of everything we do. Our reputation is shaped by the personal decisions of every employee. Our staff strive to be decent and fair-minded, and do what is right on the job, even in the most difficult situations.
Our Code of Conduct, Doing the Right Thing, paints a clear picture of what we stand for as an organization, what we expect of ourselves and what we must do to maintain our reputation. It governs how we carry out our work and clarifies what each of us must do.