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)
Services
End-to-end clinical trial 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.
Data management and database services
CRF design (paper and electronic), database design/validation, remote data capture, query management, data cleaning, MedDRA coding, CDISC mapping and database lock.
Statistical consulting and analysis
Sample size estimation, drafting statistical sections of protocols, SAP development, interim and final analyses, production of tables/listings/figures, and support for scientific publications.
Pharmacovigilance and safety services
24/7 safety coverage, management of regulatory safety reporting workflows, SUSAR handling and DSUR preparation/submission.
Medical writing and regulatory dossiers
Preparation of ICH-compliant clinical study reports, investigator brochures, IMPD/technical files, protocols and other regulatory and scientific documents.
Investigational product and logistics management
Storage, packaging, labeling and supply management of investigational products in compliance with cGMP/GLP standards; coordination of study product/sample shipments.
End-to-end clinical trial 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.
Data management and database services
CRF design (paper and electronic), database design/validation, remote data capture, query management, data cleaning, MedDRA coding, CDISC mapping and database lock.
Statistical consulting and analysis
Sample size estimation, drafting statistical sections of protocols, SAP development, interim and final analyses, production of tables/listings/figures, and support for scientific publications.
Pharmacovigilance and safety services
24/7 safety coverage, management of regulatory safety reporting workflows, SUSAR handling and DSUR preparation/submission.
Medical writing and regulatory dossiers
Preparation of ICH-compliant clinical study reports, investigator brochures, IMPD/technical files, protocols and other regulatory and scientific documents.
Investigational product and logistics management
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