Data representative, GDPR compliance services & Legal consultancy According to GDPR’s articles 3 and 27, when a company not based in EU territory offers goods or services to a data subject in the European Union, or its activity requires monitoring the behavior of the data subject in the European Union (such as participants to clinical …
Investigator / Study site audits Assessing the compliance with the applicable standards of Good Clinical Practice (GCP), National Regulation, and GDPR regulation Tour of site, documentation’ check (availability, the validity of SOPs, protocol, ICF, CRF, source documents, etc.), archiving of documents Evaluation of Personnel, i.e. training and experience of the personnel, study team workload Source …
Statistical programmers at VALOS provide clinical study reports as submission-ready deliverables to clients in a bid to make their clinical trials more effective. Fully realizing that different clients require different levels of support, the statistical programming team recommends and delivers tailor made solutions to suit their needs, ranging from reporting and delivering large submission studies, …
Our Data Management offers full-service, select services or functional service provider (FSP) partnership. DM team follows Good Clinical Data Management Practices (GCDMP), CDISC CDASH standard and is experienced in working with Medidata RAVE, Oracle Inform , Oracle Clinical One and Viedoc EDC systems.
Biostatisticians at VALOS blend their expertise in statistics with their in-depth experience of programming to deliver integrated solutions to our clients with the aim to make their clinical trials more efficient and guarantee quality results. Our subject matter experts demonstrate their prowess in this highly challenging field of science and research by working with clients …
To support your launch preparation, reimbursement submission, pricing and Market Access strategies we can build together database analyses for:
ITALY (registered office) Via Bartolomeo Bosco 57/5, 16121 Genova
ITALY (head office) Via Ceccardi 4/31, 16121 Genova
USA 82 Wendell Ave. Ste 100, Pittsfield, MA 01201
