CRO - Contract Research Organization

LNAge is a CRO Contract Research Organization that offers its support and its high professionalism in the field of clinical and health research to pharmaceutical and hospital companies, industries operating in the biotechnology sector and university research centers, in their research and development activities of therapeutic protocols, drugs, medical devices, supplements and functional cosmetics. Sponsors and other client companies turn to LNAge when they decide to promote clinical research. This kind of activity, which LNAge has been carrying out with passion and professionalism for years, involves a series of actions and specific professionalism and can take the form of the development of new products at a preclinical level, in the organization and management of clinical trials or, again, in the marketing and post-marketing of a research activity carried out previously, according to specific guidelines, based on strict protocols. The sponsoring company, be it a large pharmaceutical company, another Clinical Research Organization (private research body), a hospital or a university research center, turning to a CRO, to conduct parts of its research, still manages to deal with phases of fundamental importance in clinical trials such as, for example, Research and Development or basic marketing and, on the other hand, it benefits small and medium-sized companies with a high specialization on a single aspect of the research or clinical trial undertaken, such as the CRO Contract Research Organization.

 

 

CRO Contract Research Organization

why request support?

As CRO LNAge, thanks to its prolonged experience and the high professionalism of its internal resources and its external collaborators, brings an undoubted advantage to the sponsoring company of the pharmaceutical and biotechnological sector, the latter, in fact, outsources a part of its activities and thus manages to save on costs (which would be much higher if the same activities were entrusted and conducted by less specialized professionals); in addition, the time required to complete clinical trials is significantly reduced. Carrying out a part of the clinical research activity in outsourcing, turning to a contract research organization, also helps the sponsoring companies to focus on internal activities and allows them to convert into variable costs the fixed costs that, otherwise, they would have to bear for the staff, for the training of skills and for the maintenance of the facilities necessary for the management of the clinical trial activity.

Another reason why a sponsoring company, based in a foreign state, decides to turn to a CRO Contract Research Organization, such as LNAge, is the need to have professionals who have a thorough knowledge of the legislation and regulations on pharmaceutical matters of a given foreign country, in our case Italy, where the sponsor intends to conduct clinical trials; in this same country the sponsoring company will have to take care to also have an adequate presence at the legal level.

 

CRO Contract Research Organization

the skills of LNAge

A contract research organization generally works for different sponsors and also interfaces with other companies where a new therapeutic protocol or a new medical device is tested. A CRO also supports its sponsors in some or all phases of the research, focusing on different aspects of the clinical trial. Precisely for this reason LNAge has professionals with different skills and experiences, who are able to carry out different activities related to the same research and clinical trial project. Within LNAge, as in any other CRO, the figure of the Monitor is of fundamental importance, acting as a natural interface and the main link between the company promoting the clinical trial and the realities selected for the investigation and experimentation activities.

The services offered as part of cro's activity concern: the development of medical products and devices, clinical trial management, the development of monitoring plans, the evaluation and selection of experimental sites through feasibility studies, clinical and medical monitoring, staff training and training, data entry and data management activities, pharmacovigilance, medical writing and support for regulatory activities.

The many years of experience and the results obtained have led LNAge to provide support and to provide training activities to other contract research organizations and Clinical Research Organizations with which our company has had consolidated partnership relationships for years.

 

The activities carried out by LNAge

the services offered in clinical research

 

Among the activities that LNAge carries out as a CRO Contract Research Organization we point out:

• carrying out feasibility studies;
• design of the study and development of the protocol (activity, the latter, supervised by expert Key Opinion Leaders);
• revision of the protocol design (activity, supervised by experienced Key Opinion Leaders);
• sample estimation and preparation of the statistical analysis plan (SAP);
• selection of investigators and provision of mapping of centers, based on the center's previous clinical experience in clinical trials;
• sending of documentation of ethics committees and handling of administrative practices and ethical-deontological obligations;
• design of paper and electronic Case Report Forms (CRFs) to facilitate the compilation activity carried out by the experimenters and allow real-time analysis;
• design and delivery of training and information programs that facilitate the recruitment and maintenance of patients within the practice;
• Institutionalization of the product or therapeutic protocol, previously studied, through the supervision of the accreditation process provided for by the Ministry of Health;
• design and delivery of training, information and coordination programs for the management of institutional Quality Centers;
• repackaging, coding and labelling of investigational drugs;
• facilitation and maintenance of constant relationships between investigators and sponsoring company in the context of sponsored investigation studies;
• choice and management of any support CRO (a scientific structure that, in turn, supports the research activity carried out by LNAge, for particular aspects of the study) both in clinical trials sponsored by the client company to LNAge, and in non-profit studies between principal investigator and CRO;
• support and advice in the search for funds for non-profit studies AIFA and other origins.

 

 

Clinical Research Associate

who he is and what he does

 

In a CRO Contract Research Organization the monitoring activity is carried out by professionals who are also known as Clinical Research Associate (CRA). It is a professional figure of primary importance because it organizes, follows and constantly verifies the evolution of clinical trials in the experimental structures (hospitals or clinics) where they are carried out. The CRA, in particular:

• verifies and ensures compliance with the clinical protocol of which it also takes care of the development and drafting;
• identifies and evaluates centres potentially suitable or potentially interested in testing through feasibility studies;
• submits the study procedures and the trial protocol to the doctors who will perform the research, instructing themselves on the specific actions to be carried out (in the visit at the beginning of the study);
• carries out frequent visits to the testing center to evaluate its activities and the correct insertion of clinical data in the database;
• archives the documents related to the study and ensures their constant updating, during the different phases;
• It guarantees the constant supply to the center to which the material to be tested is regularly sent (be it drug or other) and, through the activity of Drug Accountability, also deals with the destruction of the tested product;
• It provides for the closure of the experimentation centers, at the end of the study, when the Close-Out Visit takes place;
• prepares the end-of-study reports;

 

With the progressive outsourcing of activities related to clinical trials, that of the CRA has become a professional figure (characterized by specific academic and professional training) of ever increasing relevance not only in pharmaceutical companies but also in cro Contract Research Organizations that often owe these same professionals success in clinical trials undertaken.