Administration of research protocols.
Administration of Clinical Research Projects
INFINITE is integrated by a team of experienced professionals in clinical research, we have a training program within the company that allows the development of the activities of monitoring and follow-up of the different stages in the development of clinical research, as well as the activities relating to this that may be required by the project, these activities include: project management (PM), elaboration of feasibility in clinical studies, evaluation of research sites, processing of monitoring plans, training research staff in good clinical practice (GCP & ICH), participation in meetings of researchers, home visits, visits and visits of interim closure.
INFINITE agrees with your research project and supports the research sites in the development and implementation of standardized processes of operation (SOP’s), which will guide you in the development and delivery of clinical research procedures in accordance with the standards of accreditation. With the implementation of these standards in the research sites, INFINITE ensures greater quality in each one of the activities for the control in the processes of clinical research.
INFINITE supports the project, providing his network of specialists and research sites of international renown, these sites are a great experience in the management of clinical studies, as well as selection and recruitment of patients for the conduct of clinical research protocols, always complying with international guidelines on good clinical practice (GCP), International Conference on Harmonisation (ICH), declarations of Helsinki, as well as all the rules of local and international authorities, in infinite we care of operational ethics within all of our processes to provide high quality results, in a timely manner.
Clinical Monitoring
INFINITE offers you the services of clinical monitoring with highly qualified staff and trained, which has solid experience in conducting clinical research protocols with a unique flexibility in the market. At the same time, infinite has a network of specialists in major therapeutic areas for the development of clinical research protocols according to the scientific methodology to assess the safety and efficacy of new molecules, medical devices, medications, herbalists, Vitamin supplements, orphan drugs, medical technology, as well as the development of new foods and cosmetics.
INFINITE manages monitoring study of services in all selected sites for the protocol in accordance with domestic and international regulations and guides (GCP and ICH), the range of services of infinite related to the conduct of protocols can be selected in a modular way, and these may include:
Selection of investigators
Selection of research sites
Quality audits
Monitoring Visits: Remote and on sites.
Starting the clinical study with all the support regulatory framework
Monitoreo clínico interno
Coordination and reporting of site visits for research
Handling and processing of the data resulting from the monitoring of the study
Armed regulatory documentation. (TMF, SMF)
Project Management (PM)
Development of monitoring plans
Administration and selection of resources
Monitoring the monitoring plan
Logistics and supplies monitoring of the study
Medical-sponsor interlocutor and communication with committees
Resolution of ‘queries’, deviations, violations and reporting of adverse events
The INFINITE experience
Our great flexibility, our cooperation , institutional agility, our team of highly trained and the domain of knowledge of local and regional regulatory landscape make us unique in the market, combined with our extensive experience conducting clinical protocols in the majority of the therapeutic areas, make us your best ally to the success of your research project.
INFINITE is distinguished from other competing undertakings by its flexibility unique in the market, which allows you to add in a modular way what services are needed for your project and with a contract tailored to meet all your needs. This is in addition to our great experience in the handling of regulatory issues with local authorities and our high level to adapt the protocols for COFEPRIS, this has distinguished INFINITE since the beginning of its operations.
Throughout all the years of experience of infinite we have worked with most of the therapeutic areas, such as:
