Clinical Studies

Contract Research Organization

In its activity of Contract Research Organization in Rome LNAge supports pharmaceutical companies, hospitals and public and private research centers in all phases of clinical trials for the formulation and development of medical devices, therapeutic protocols, supplements and functional cosmetics

Clinical Trial

The LNAge CRAs design and manage every phase of the Clinical Trial: from the design to the preclinical phase, from the study start visit to the experimentation phases, up to the reporting. Clinical trials focus on health treatments, pharmacological aspects or investigations on biomedical technologies.

Clinical Trial Management

Thanks to an integrated approach that allows to monitor the entire clinical trial, LNAge can assist the customer in the development process of pharmaceutical products under GCP. From the design of the study, to biostatistics, to the ICH report and post-marketing verifications (late phase studies and PASS).

Regulatory

We offer comprehensive and timely legal advice on all regulatory activities related to the research, formulation and development of medical devices. We provide assistance and support in all the obligations and actions necessary for approval, marking and placing on the market

MD Technologies Medical Devices

Our Medical Device Technology experts design and carry out clinical studies aimed at the creation of new chemical-physical, mechanical or electronic medical devices: from the formulation of the active ingredient or therapeutic protocol to its development, up to experimentation and post-marketing surveillance.

Quality Assurance

In the activity of pharmaceutical Quality Assurance we formulate SOP and carry out a constant monitoring and careful quality control of the business processes of the partners, to prepare also proprietary quality control systems. The LNAge Quality System is ISO 9001 certified

Audit ICH GCP

Sponsors may request a GCP Audit on third-party suppliers and research laboratories involved in clinical trials, to obtain an objective assessment of the procedures put in place and, if necessary, provide for the actions necessary for adaptation to GCP ICH

Medical Writing

We take care of the drafting of the documents necessary for the progress and reporting of clinical trials: from CRFs to study protocols, to informed consent forms, up to end-of-study reports. We also deal with scientific publications for our research and on behalf of third parties.

Marketing

We support client companies in the choice of packaging and take care of the design, design and dissemination of brands of medical devices, dermocosmetics and food supplements. We plan marketing campaigns for the positioning of new products, health services or therapeutic protocols

Formation

We provide training to illustrate to professionals from other CROs and medical staff the properties of new medical devices being tested or tested in previous clinical trials. We conduct university and professional training activities, also for the achievement of training credits.