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Medical Device Research Protocols

INFINITE is par excellence the reference company within the Latin American region, due to its vast experience in the effective conduct of clinical research protocols. INFINITE as an expert company in clinical research provides you with the necessary services to successfully manage the conduct of clinical protocols in medical devices and / or medical technology. INFINITE supports you with: the selection of sites and researchers, recruitment of subjects of study, management of regulatory matters, among others, all these services are executed with the high commitment to provide you with a high quality service, so that your clinical research project be executed successfully and satisfactorily for all parties involved.

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Management of research protocols

Administration of Medical Devices Research projects.

INFINITE’s human capital is made up of a team of professionals experienced in the correct management of a clinical research project, we have internal training programs for all our staff, which allows the development of monitoring and follow-up activities of all the stages of the project can be carried out through our project coordinators (PM), within all the activities that INFINITE carries out are: project management (PM), elaboration of the feasibility in clinical studies, evaluation of research sites, Development of monitoring plans, training of research staff (GCP & ICH), participation in research meetings, initial visits, interim visits and closing visits.

management-research-protocols

In INFINITE we commit to your project, we make the established objectives and goals our own, that is why we provide support to all selected research sites in the development and implementation of standardized operating processes (SOPs), these will serve guide in the development and delivery of clinical research results in accordance with established international accreditation standards. With the implementation of these standards in the research sites, INFINITE ensures a higher quality in each of the activities for the control in the project processes.

INFINITE supports you in the development of your project through its network of specialists and internationally renowned research sites, these sites have extensive experience in the management of clinical studies, as well as the selection and recruitment of patients to conduct the protocols of clinical research, always complying with the international guidelines of good clinical practice (GCP), international harmonization conference (ICH), statements of Helsinki, as well as all the regulations of local and international authorities. The INFINITE team always takes care of operational ethics within all its processes to provide high quality results.

Clinical Monitoring for Medical Devices

INFINITE offers you the services of clinical monitoring with highly qualified and trained personnel, which has solid experience in conducting clinical research protocols with a unique flexibility in the market. In turn, INFINITE has a network of specialists in the main therapeutic areas for the development of clinical research protocols according to the scientific methodology that allows to evaluate the safety and efficacy of new molecules, medical devices, herbal medicines, vitamins, orphan drugs , medical technology, as well as development of new foods and cosmetics.

INFINITE manages monitoring study services in all the sites selected for the protocol according to national, international standards and guides (GCP and ICH), the range of INFINITE services related to the conduction of protocols can be selected in a modular way and these They could include:

Selection of researchers

Selection of research sites

Quality audits

Start visits, interim visits and protocol closure

Start of the clinical study with all regulatory support

Interim clinical monitoring

Coordination and report of research visits

Management and processing of the data resulting from the monitoring of the study