Should we not concider the institutional entrepreneurs as actors in the upheaval of the statutory, normative and cognitive systems?

Several empirical studies tried to understand mechanisms and effects which underly these activities (Hardy and Maguire, on 2008). It is the case of the reconstruction of the European Union (Fligstein, on 2001).

We identified institutional companies on our ground:

Clinical Trials Transformation Initiative - CTTI: non-profit organization, the members include the representatives of governmental organisms, representatives of industry, of associations, of patients, professionals companies, groups of investigators, Academics' institutions and other interested parties.

Consortium Transcelerate: a non-profit organization whose mission is to collaborate through the biopharmaceutical community of research and development conceived  to identify, prioritize, conceive and facilitate the implementation of solutions of high quality in particular in the field of the RBM.

" All the institutions are not concerned by the institutional work. So that actors can decide to create, to question or to maintain an institution it needs that this one  is clearly identified as a social construction get to be organized or questioned by means of strategic actions. " (Slimane and Leca, on 2010).

Within the framework of a research-action, we try an entrepreneurial experience:

We set up a community of practice in the area, the object of which is the definition of the notion of

" ethical risk " of the clinical development; the evaluation of the conformity in regulations and existing standards; a feasibility study for the implementation of " Monitoring" in health; the development of a proposal of notation of the risk of the  clinical testing (principle of the actuarial affairs).

This community epistemic and professional, that we indicate by the brand " Intelligence In Life " (IIL) is a collaborative space (laboratory of ideas and projects) which groups includes: researchers and designers of products of health (medicinal and not medicinal); experts in regulations and standards; patients' committees; teachers-researchers in human sciences; experts in financial and insurance-related risks; invited representatives of the justifiable institutions and the competent authorities.

The begun work, aims at giving a scientific basis to the emergence of new tools of the security business intelligence in the field of the clinical development of the products of health.

In the epistemological plan, in a posture of constructivism ingénierique, we question the ground with a will of transformation of the modes of traditional answers in the studied context.

We hope to develop a model or, at least, to enrich exixting models, by co-construction on the ground, on the one hand, and feasibility on the other (Le Moigne, 1995).

 

This does not therefore exclude critical realism:

We are probably able to interpret the postures of actors, our interactions during field studies, while postulating that there are perceived limits:

​1 - An ultimate and ontological limit in the descriptibility of the relationship (intersubjective, interactionist and symbolic) between a patient who has become an object of science and a doctor who has become investigateur.

​2 - Constraints imposed by legacy Information Systems and organizational inertia (Cohen and Levinthal, 1990).

​Is it possible to create meaning through a process of collective intelligence that goes beyond the walls
of the company producing health products and thus make emerge a process of monitoring strategic (Amabile, 1999) at stakeholder level (Promoter Laboratories, CRO Contract Research Organisation and Health Authorities)?

Will this process (Arena and al., 2015) be able to prevent serious adverse events affecting patient subjects ? But also to detect, prevent or attest to fraud or misconduct in unethical trials; and thus maintain the clinical research approach in an “acceptable security envelope”?
 

This is the security challenge for industries and the health care system by 2030, to which we let us take part in this basic research.