Planimeter is a full service CRO with strong mathematical background. Our primary focus is on data management and full statistical support of Phase I-IV clinical trials, epidemiological surveys or post-marketing studies.
We developed our first eCRF (electronic Case Report Form) system in 2005. During the last 11 years we implemented more than 50 studies of Phase I-IV on this platform worldwide from Canada to Bulgaria. The fully CFR 21 Part 11 compliant system achieved an ISO-qualification in 2014.
We developed a Customer Research Management system – CRM in short – which is unique in that meaning that it is able to cover all the aspects of design and conduction of a clinical trial or post-marketing survey.
CDISC (Clinical Data Interchange Standards Consortium) is an organization that develops industry standards. The standards support the electronic acquisition, exchange, and archival of clinical trials data and metadata for medical and biopharmaceutical product development. CDISC defines several data models for the interoperability of clinical data exchange.
DM and STAT
We are able to enter data from paper sources but we also developed an ISO qualified electronic case report form system for electronic data collection. We follow CDISC CDASH guidance in CRF development. Though we have a very experienced data management department – generally we do not work with temporary staff – we also put in operation a highly sophisticated quality assurance system for data quality monitoring.