After the news of the opening of a representative office in Taiwan, the COMPLIFE Group reports the attention on Clinical Tests: after communicating the acquisition of the French Dermatec, on March 8 opens a new laboratory in Italy, in Garbagnate Milanese.

Dr Angela Michelotti, Head of Clinical Testing Laboratories, explains the reasons for this choice.
The opening of the new Clinical Trials Laboratory is part of the Group’s growth context and part of the qualification of competent figures and specialized structures in different areas of clinical research. Customer requests are increasingly challenging with regard to the requirements of the panel, the required instrumentation and also the personal skills of our technicians. In order to be able to satisfy our customers, mission of Complife, we need a large, multi-ethnic panel of volunteers, representative of all age groups and of all the target skin characteristics of innovative products. Clinical trials also require adequate space for the reception of volunteers, their acclimatization, as well as studies where the scientific medical staff involved can inform the volunteer, include it in the study and acquire the clinical-instrumental evaluations provided. Therefore, the involvement of different geographical areas in order to increase our catchment area can be achieved with the on-site development of structured laboratories for the execution of clinical studies.

How are these Complife volunteers followed? What guarantees are given to them?
Complife ensures the application of appropriate protocols and compliance with confidentiality systems that ensure the protection of the identity of volunteers and their personal data. Specialised doctors, such as dermatologists, ophthalmologists, dentists, gynaecologists and paediatricians, supervise that the applied protocol does not present residual risks for volunteers, as well as the adequacy of their inclusion. The tests are then carried out under the supervision of these doctors, so the guaranteed level of safety is high. The complexity of the studies goes hand in hand with the more careful protection of the safety of volunteers and sometimes the approval of protocols is also required by an Independent Ethics Committee.
What are the guarantees for the Complife client?
The clinical study in the context of the development of a project is certainly a delicate as well as strategic point: confirms the tolerability in use of the product and its performance. The results of the study complement the PIF, support the sales material and will be subject to inspection by the authorities if needed. The ten-year experience and the continuous updating of the Complife Group, together with the competence of the technical regulatory staff, have led to the development of a working method based on good practice described in standard procedures that follow all crucial phases of the study development:

• definition of clinical protocol and statistical plan
• definition of the representative panel statistical sample of the product target
• data collection sheets for recording clinical and instrumental outputs
• monitoring of panel compliance with inclusion and non-inclusion criteria throughout the study
• management of ethical requirements
• development of a final report with the results of the study supported statistical analysis

The new Laboratory of Garbagnate will be managed by Valentina Cortale. What should we expect from the new Laboratory?
The Garbagnate laboratory supports and completes the activities of the laboratories of the clinical department. At first glance it might seem a fragmented department, precisely because the laboratories are located in different geographical areas, but the laboratory of Garbagnate was born following the philosophy of Complife to give continuity and homogeneity to their work. Valentina Cortale, Senior Technician of the Clinical Research Department, will transmit the operation and skills to the new staff of Garbagnate who will work in perfect harmony and standardization with the other clinical laboratories of the group.

How are volunteer testers recruited? Are there more required profiles than others?
The search for volunteers takes place through several channels, first of all word of mouth, together with advertising on our website for clinical trials with requirements related to the so-called general population (aging, support for claims related to make-up, consumer testing…). Complife offers its network of skills and organization also for the realization of complex clinical projects that require dedicated panels (e.g. atopic dermatitis, acne skin, products for the intimate area, pediatric products, food supplements…) – in such cases, dedicated campaigns may also be necessary, followed by our experts in collaboration with specialist doctors or with the support of recruitment agencies. Certainly the product launches follow seasonal trends, with the consequent massive demand for skin types in certain periods. The possibility of Complife to work in different geographical areas means that the catchment area is large enough to allow the simultaneous recruitment of panels with overlapping characteristics and to conduct studies in compliance with the periods of treatment and rest between studies and the other.

The Complife Clinical Laboratories in Italy are in Milan, Biella, San Martino Siccomario (PV) and Garbagnate Milanese (MI). For information please contact (0039)0382.25504.