LNAge is a Full Service Contract Research Organization, able to conduct Clinical Trial management activities and, therefore, to follow the entire process of implementation of its customers' clinical trials by virtue of the experience acquired, its internal skills and the fruitful collaborations established with technical partners of high quality and reliability. Thanks to this integrated approach, LNAge can assist the customer in all aspects of the development of pharmaceutical products under Good Practice (GCP, GLP, GMP), from the design of the study to the drafting of the clinical study report, with a global vision and compliant with regulatory and regulatory obligations. The experience gained by LNAge covers all phases of clinical research, from the first steps of product development (early phase studies) to post-marketing verifications (late phase studies, Post Authorization Safety Studies / PASS) and includes the organization and management of both interventional and observational clinical trials.
The technical-scientific and formal appropriateness of the Clinical Protocol is undoubtedly the key for a trial to provide solid and reliable results. A correct experimental design and an adequate presentation of the rationale of the research and of all the operational components necessary for its conduct therefore play a crucial role. The LNAge experts assist the sponsor in this preliminary phase of Clinical Trial management through the conduct of in-depth bibliographic research and providing, in agreement with the Sponsor and the Principal Investigator, the drafting of the clinical protocol and technical documents (e.g. Synopsis, Informed Consent Form, Investigator's Brochure) as well as the definition of the procedures for management, the conduct and coordination of the study.
In LNAge, the experts in regulatory practices work in coordination with the Clinical Project Manager responsible for each project, providing according to the indications of the Sponsor to the preparation of all the documentation necessary for obtaining the authorizations and the relative submission to the Competent Authorities.
Each clinical research project assigned to LNAge provides for the assignment of a Clinical Project Manager (CPM) of reference for the Sponsor, expressly dedicated to the organization of the operations of the study. The CPM is responsible for coordinating all activities, including overseeing Clinical Research Associates (CRAs) and dealings with other actors involved such as the Sponsor, Investigators and Ethics Committees (CE). All CRAs involved in a study participate in a study-specific training, aimed at familiarizing themselves with the technical-scientific and operational aspects of the trial. The staff assigned to the study provides for the preparation and real-time updating of the Trial Master File and the related Site Investigator's Files, as well as the preparation and management of any amendments and continuous assistance to the investigator on the procedures of the study. CRAs organize and conduct monitoring visits to clinical sites according to the timelines agreed with the investigator and sponsor, documenting everything through the drafting and sending to the Sponsor of monitoring visit reports (MVR).
In LNAge all CRAs are in possession of certification pursuant to Ministerial Decree 15/11/2011.
As part of its Clinical Trial management activities, LNAge can take care of the management, collection, evaluation, analysis and reporting of adverse events occurring during the intake of experimental pharmaceutical products (both pre- and post-marketing), including serious adverse events (SAEs) and unexpected serious adverse reactions (SusaRs). The management phase includes continuous contact with the investigators and the Sponsor to ensure real-time updating on the outcome of events requiring particular attention as well as the completion of the relevant documentation and, when required, the MedDRA coding.
The drawing of Case Report Forms (CRF) conforming to the needs of the protocol, validated through appropriate tests, can be performed by LNAge both in paper and electronic format. For the implementation of the e-CRF platform we use long-standing collaborations with reliable partners operating in close contact with the project CPM and with the data management manager (DM). To proceed with the database lock before the development of interim or conclusive analyses, we guarantee appropriate management and resolution of queries and data cleaning, data coding in accordance with the relevant standard dictionaries and reconciliation of adverse events. Our biostatistics staff provides sample size processing, statistical data analysis (SAP) plan, planning and management of the randomization procedure (in agreement with the CPM) and performing statistical analysis of the study results.
The Clinical Trial Management service concludes with the drafting of the clinical study report in accordance with the international guidelines dictated by the International Conference on Harmonization (ICH E3).