Best in class medical device CRO

ECLEVAR MEDTECH is a global CRO, headquartered in Paris. We support medical device and IVD manufacturer in the MDR and IVDR transition. Our team works as an extension team of medical affairs and regulatory affairs sponsor.
We offer customized service, personalized to the need of our clients. Whether you are looking for full service CRO or staffing clinical or regulatory experts, our management team with more than 20 years experience will drive you to the effective solution

VALUES

An agile CRO for complex clinical studies

MISSION

Make clinical trials affordable to the Medtech industry

VISION

Cost effectiveness, time savings and management of regulatory constraints.

What is medical device CRO or In-Vitro Diagnostic Devices CRO?

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). Their 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 or 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.

Definition, regulatory aspects

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:

(5.2.1) A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
(5.2.2) Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).

(5.2.3) Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
(5.2.4) All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.

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”.

Outsourcing duties and function to a Medical device CRO according to ISO14155:2020:

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.

Relationship continuum: Tactical to strategic

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.

Governance strategy and operating model

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.

Efficiencies in clinical project management

In project management, there are four major areas of emphasis required to drive efficiencies between the sponsor and Medical device CRO:

Role clarity: There is often duplication of effort and inconsistent delegation of tasks and responsibilities. Documenting how tasks are delineated between the partners will help clarify and standardize roles and responsibilities.
Proposal optimization: When sponsors fully define the study scope, they leave little ability for CROs to make positive contributions to strategy. Instead, CROs should be allowed to develop a detailed study execution strategy. This leverages the collective experience of all partners to help optimize study costs and timescales.
Meeting efficiency: Excessive numbers of internal meetings to report similar information can sub- optimize the study initiation process. Optimizing meeting timing and management using a revised approach for kick-off and strategy sessions can enable more efficient study start up and proactive risk management.
Study planning and reporting: Study status reports, study templates, and reporting frequency across sponsor studies may vary widely. Introducing standard study status reporting tools and study management plans can establish common expectations and reduce ad hoc requests for information.

CRO Culture:

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.

Learn more about our culture and team:

“Regulatory evolutions differ from one region to another: they have their own rules and requirements for medical devices. It is crucial to partner with a CRO that understands and handles these challenges.”

CHEMS HACHANI

CEO, Eclevar