Latis
Latis is a Contract Research Organization established in 2012, based in Genova, Italy, specializing in supporting the design and management of clinical trials across various phases and therapeutic areas. The company offers comprehensive services including pre-study activities, drug management, medical writing, data management, statistics, and more, tailored to client needs. With a team of experienced professionals and adherence to quality standards like ISO 9001:2015, Latis aims to provide reliable, efficient, and high-quality clinical research services, fostering continuous improvement and client satisfaction.
Industries
Nr. of Employees
small (1-50)
Products
Medical Affair
Dalla generazione dell’evidenza alla valorizzazione clinica: competenze scientifiche al servizio dell’innovazione.
CRO
Ricerca clinica integrata, dati reali e innovazione tecnologica per validare la sicurezza, l’efficacia e il valore terapeutico dei prodotti.
Real World Evidence
Real World Evidence (RWE) services utilizing data from clinical practice to support regulatory dossiers, HTA analysis, and pharmacoeconomic evaluations.
Hybrid Decentralized Clinical Trials Solutions
Decentralized and hybrid clinical trial services utilizing technology and telemedicine to conduct remote processes and enhance patient engagement.
Medical Affair
Dalla generazione dell’evidenza alla valorizzazione clinica: competenze scientifiche al servizio dell’innovazione.
CRO
Ricerca clinica integrata, dati reali e innovazione tecnologica per validare la sicurezza, l’efficacia e il valore terapeutico dei prodotti.
Real World Evidence
Real World Evidence (RWE) services utilizing data from clinical practice to support regulatory dossiers, HTA analysis, and pharmacoeconomic evaluations.
Hybrid Decentralized Clinical Trials Solutions
Decentralized and hybrid clinical trial services utilizing technology and telemedicine to conduct remote processes and enhance patient engagement.
Services
Support across the full clinical study lifecycle: pre-study planning, protocol/synopsis writing, informed consent and CRF design, site selection, start-up, monitoring, close-out and final clinical study report preparation.
CRF design (paper and electronic), database design/validation, remote data capture, query management, data cleaning, MedDRA coding, CDISC mapping and database lock.
Sample size estimation, drafting statistical sections of protocols, SAP development, interim and final analyses, production of tables/listings/figures, and support for scientific publications.
24/7 safety coverage, management of regulatory safety reporting workflows, SUSAR handling and DSUR preparation/submission.
Preparation of ICH-compliant clinical study reports, investigator brochures, IMPD/technical files, protocols and other regulatory and scientific documents.
Storage, packaging, labeling and supply management of investigational products in compliance with cGMP/GLP standards; coordination of study product/sample shipments.
Support across the full clinical study lifecycle: pre-study planning, protocol/synopsis writing, informed consent and CRF design, site selection, start-up, monitoring, close-out and final clinical study report preparation.
CRF design (paper and electronic), database design/validation, remote data capture, query management, data cleaning, MedDRA coding, CDISC mapping and database lock.
Sample size estimation, drafting statistical sections of protocols, SAP development, interim and final analyses, production of tables/listings/figures, and support for scientific publications.
24/7 safety coverage, management of regulatory safety reporting workflows, SUSAR handling and DSUR preparation/submission.
Preparation of ICH-compliant clinical study reports, investigator brochures, IMPD/technical files, protocols and other regulatory and scientific documents.
Storage, packaging, labeling and supply management of investigational products in compliance with cGMP/GLP standards; coordination of study product/sample shipments.
Expertise Areas
- Clinical trial management (Phase I–IV and bioequivalence)
- Study start-up and regulatory submissions
- Data management and CDISC conversion
- Statistical planning and analysis (including adaptive designs)
Key Technologies
- Electronic data capture (eCRF) with 21 CFR Part 11 compliance
- Electronic audit trail and access logging
- CDISC standards (CDASH, SDTM, ADaM)
- MedDRA coding