Discovering our professions: Chief Medical Officer
[mk_page_section bg_image=”/wp-content/uploads/sites/3/2017/07/clinic-specialisations.jpg” bg_position=”center top” video_opacity=”0″ min_height=”0″ full_width=”true” js_vertical_centered=”true” top_shape_color=”#ffffff” bottom_shape_color=”#ffffff” sidebar=”sidebar-1″][vc_column][mk_padding_divider size=”50″ visibility=”hidden-sm”][mk_padding_divider size=”50″ visibility=”hidden-tl”][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][mk_fancy_title tag_name=”h1″ color=”#ffffff” size=”50″ force_font_size=”true” size_smallscreen=”50″ size_tablet=”50″ size_phone=”25″ font_weight=”bold” txt_transform=”uppercase” margin_bottom=”0″ font_family=”Raleway” font_type=”google”]Discovering ou professions: Chief Medical Officer[/mk_fancy_title][/vc_column_inner][/vc_row_inner][mk_padding_divider size=”50″ visibility=”hidden-sm”][mk_padding_divider size=”50″ visibility=”hidden-tl”][/vc_column][/mk_page_section][mk_page_section sidebar=”wptimeline-sidebar”][vc_column][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_empty_space height=”20px”][vc_column_text]Pierre Clerson, founder and Chief Medical Officer of Soladis Clinical Studies tells us the role of the doctor/ medical writer in clinical research.[/vc_column_text][vc_empty_space height=”20px”][/vc_column_inner][/vc_row_inner][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_empty_space height=”20px”][vc_video title=”Le métier de Directeur Médical” link=”https://www.youtube.com/watch?v=l1lsyc_GmNI”][vc_empty_space height=”20px”][/vc_column_inner][/vc_row_inner][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_column_text]Pierre Clerson – Chief Medical Officer of Soladis Clinical Studies
[/vc_column_text][vc_empty_space height=”20px”][vc_column_text]«The role of the Chief Medical Officer is to define the context of a research. It is possible to collect all the data you want but if there is no clinical common sense, if there is no macro thinking on the objective of the sponsor and the positioning of the problem within a scientific movement, everything you do is useless. Only the doctor or the Scientific Director can put into perspective, valorize, contextualize the results of the research. Furthermore, the Chief Medical Officer is the key collaborator able to talk with doctors on equal footing, to understand their clinical question.Today we have a rule that has always been that of Soladis: the constant pursuit of excellence. Although the sector is evolving, we must be the best in everything we do in order to deliver the best performance and the most efficient service possible.
At a given moment, in a given situation.
The ideal collaborator for Soladis Clinical Studies is a motivated and curious person who wants to be involved in teamwork. The value chain is delivered by a team with people who collaborate, work together and do their best for the success of their mission. The ideal collaborator is therefore someone who has a good team spirit, who has the sense of scientific curiosity and who has the will to constantly challenge oneself. »[/vc_column_text][vc_empty_space height=”20px”][vc_column_text]
Discovering our professions: Clinical Data Manager
[mk_page_section bg_image=”/wp-content/uploads/sites/3/2017/07/clinic-specialisations.jpg” bg_position=”center top” video_opacity=”0″ min_height=”0″ full_width=”true” js_vertical_centered=”true” top_shape_color=”#ffffff” bottom_shape_color=”#ffffff” sidebar=”sidebar-1″][vc_column][mk_padding_divider size=”50″ visibility=”hidden-sm”][mk_padding_divider size=”50″ visibility=”hidden-tl”][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][mk_fancy_title tag_name=”h1″ color=”#ffffff” size=”50″ force_font_size=”true” size_smallscreen=”50″ size_tablet=”50″ size_phone=”25″ font_weight=”bold” txt_transform=”uppercase” margin_bottom=”0″ font_family=”Raleway” font_type=”google”]Discovering our professions: Clinical Data Manager[/mk_fancy_title][/vc_column_inner][/vc_row_inner][mk_padding_divider size=”50″ visibility=”hidden-sm”][mk_padding_divider size=”50″ visibility=”hidden-tl”][/vc_column][/mk_page_section][mk_page_section sidebar=”wptimeline-sidebar”][vc_column][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_empty_space height=”20px”][vc_column_text] Sébastion Lecomte, in charge of clinical Data Management, presents its profession and the importance of Data Management in clinical study [/vc_column_text][vc_empty_space height=”20px”][/vc_column_inner][/vc_row_inner][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_empty_space height=”20px”][vc_video title=”Le métier de Data Manager” link=”https://www.youtube.com/watch?v=BH5MHv-jBTM”][vc_empty_space height=”20px”][/vc_column_inner][/vc_row_inner][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_column_text]Data Management can be defined by three guiding ideas, three leitmotivs. The first idea is the creation of a structure, a skeleton, a database that can collect clinical data of a patient. The second idea is to ensure the quality and consistency of the data. And the third idea is to ensure the consistency of these data regarding to a protocol. The key point is that the cleaner the database is, the more accurate the statistical analysis will be.
To conclude, we can say that in Soladis Clinical Studies, there is a team of Data Managers who can now respond to different offers and even comprehensive and large-scale offers. Indeed, Soladis Clinical Studies has a multi-skilled team that can answer different issues, since each data manager has his own, technical, functional and regulatory expertise. All these elements constitute the main strength of Soladis Clinical Studies.»[/vc_column_text][vc_empty_space height=”20px”][vc_column_text]
Discovering our professions: Clinical Project Manager
[mk_page_section bg_image=”/wp-content/uploads/sites/3/2017/07/clinic-specialisations.jpg” bg_position=”center top” video_opacity=”0″ min_height=”0″ full_width=”true” js_vertical_centered=”true” top_shape_color=”#ffffff” bottom_shape_color=”#ffffff” sidebar=”sidebar-1″][vc_column][mk_padding_divider size=”50″ visibility=”hidden-sm”][mk_padding_divider size=”50″ visibility=”hidden-tl”][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][mk_fancy_title tag_name=”h1″ color=”#ffffff” size=”50″ force_font_size=”true” size_smallscreen=”50″ size_tablet=”50″ size_phone=”25″ font_weight=”bold” txt_transform=”uppercase” margin_bottom=”0″ font_family=”Raleway” font_type=”google”]Discover our porfessions: Clinical Project Manager[/mk_fancy_title][/vc_column_inner][/vc_row_inner][mk_padding_divider size=”50″ visibility=”hidden-sm”][mk_padding_divider size=”50″ visibility=”hidden-tl”][/vc_column][/mk_page_section][mk_page_section sidebar=”wptimeline-sidebar”][vc_column][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_empty_space height=”20px”][vc_column_text]Arnaud Jaruga, Clinical Project Manager presents its profession and the impact of the evolution of regulations on it.[/vc_column_text][vc_empty_space height=”20px”][/vc_column_inner][/vc_row_inner][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_empty_space height=”20px”][vc_video title=”Le métier de Chef de Projet Clinique” link=”https://www.youtube.com/watch?v=MUTWLfhtZD8″][vc_empty_space height=”20px”][/vc_column_inner][/vc_row_inner][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_column_text]Arnaud Jaruga – Clinical Project Manager (Clinical study)
[/vc_column_text][vc_empty_space height=”20px”][vc_column_text]« The Clinical Project Manager is involved very early in the protocol of the study and the drafting of documents related to regulatory submissions. In France it can include independent ethics committee (such as the CPP: Comité de Protection des personnes), the French National Agency for Medicines and Health Products Safety (ANSM) and the National Commission on Informatics and Liberty (CNIL).
The Clinical Project Manager is also in charge of managing and monitoring the progress of the study, managing Clinical Research Associates, contracts, budget monitoring and study stakeholders. All these elements are located upstream of the study.
In the course of the study, it is essential to manage and coordinate the participants, that-is-to-say to answer questions from the centers when the CRA (Clinical Research Associate) is unavailable or cannot answer. It is also necessary to regularly report to sponsors activity reports. At the end of the study, after the statistical analysis, the Clinical Project Manager is responsible for writing the clinical report. In recent times, French regulations have evolved mainly on the deposits to the institutional review board which contributes to the evolution of Soladis’ profession.
In addition, the new General Data Protection Regulation (GDPR) leads Soladis Clinical Studies to review its methodology of drafting consents and patient briefing notes to incorporate new devices. »
Discovering our professions: CRA (Clinical Research Associate)
[mk_page_section bg_image=”/wp-content/uploads/sites/3/2017/07/clinic-specialisations.jpg” bg_position=”center top” video_opacity=”0″ min_height=”0″ full_width=”true” js_vertical_centered=”true” top_shape_color=”#ffffff” bottom_shape_color=”#ffffff” sidebar=”sidebar-1″][vc_column][mk_padding_divider size=”50″ visibility=”hidden-sm”][mk_padding_divider size=”50″ visibility=”hidden-tl”][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][mk_fancy_title tag_name=”h1″ color=”#ffffff” size=”50″ force_font_size=”true” size_smallscreen=”50″ size_tablet=”50″ size_phone=”25″ font_weight=”bold” txt_transform=”uppercase” margin_bottom=”0″ font_family=”Raleway” font_type=”google”]Discovering our professions: CRA (Clinical Research Associate) [/mk_fancy_title][/vc_column_inner][/vc_row_inner][mk_padding_divider size=”50″ visibility=”hidden-sm”][mk_padding_divider size=”50″ visibility=”hidden-tl”][/vc_column][/mk_page_section][mk_page_section sidebar=”wptimeline-sidebar”][vc_column][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_empty_space height=”20px”][vc_column_text]Claire Lemaitre, Clinical Research Associate and Clinical Project Manager, presents the profession of CRA (Clinical Research Associate) and the impact of the sector development on the profession.[/vc_column_text][vc_empty_space height=”20px”][/vc_column_inner][/vc_row_inner][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_empty_space height=”20px”][vc_video title=”Le métier de l’ARC” link=”https://www.youtube.com/watch?v=ozhRWV2Sk9M”][vc_empty_space height=”20px”][/vc_column_inner][/vc_row_inner][vc_row_inner is_fullwidth_content=”false”][vc_column_inner][vc_column_text]Claire Lemaitre – CRA (Clinical Research Associate)
«The Clinical Research Associate monitors clinical studies at the research center level. At the beginning of the study, he will first select the participating centers, and then train them according to the study protocol.
Thereafter he will be the privileged contact of these centers and accompany them daily in the clinical study.
Within Soladis Clinical Studies, the Clinical Research Associate will be involved in quite different studies, both interventional and non-interventional, on drugs or medical devices, and on various therapeutic areas, and he will remotely follow studies and also alongside medical teams during his monitoring visits.
The sector is evolving considerably, particularly at the regulatory level, which involves constantly keeping up-to-date to be sure to apply good legislation and adapt our practice to it, in addition to adapting to the evolution of the sector. It should be known, for example, that nowadays the majority of data are collected with electronic case report forms (eCRF) at the expense of paper case report forms (CRF), enabling a remote and constant access to most data of the study.
So, thanks to these technical tools it is possible to have a closer and real daily monitoring of our clinical studies and have regular reports with research centers if we observe inconsistencies to correct directly with them.
Interventional studies require a much closer follow-up, it is therefore necessary to remotely monitor them more intensively than an observational study where we simply collect data contained in the patient’s medical file that does not require a sustained follow-up.
The objective of the Clinical Research Associate and the Clinical Team is to constantly adapt to the evolution of the study in order to make thoughtful actions in line with the needs of the sponsor, and which are appropriate to the legislation.»
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