In today’s clinical research environment with international projects, adaptive trial designs, global data strategies and risk based monitoring, Sponsors count on highly specialized, professional teams of experts to help ensure successful drug development.
Outsourcing important services such as data management, statistics and eCRF development to a CRO, means choosing a service provider able to guarantee proper statistical methodology, streamlined data management processes and adequate implementation of quality management systems. In part, it means putting projects in the hands of Biostatisticians who play a fundamental role throughout all stages of the trial process. From designing protocols and CRFs and planning the analysis to analyzing and preparing interim and final reports, these qualified, experienced individuals help ensure the overall success of projects and guarantee that regulatory requirements from EMA and the FDA are met.
Thanks to years of investment in expert personnel together with the fact that biostatistics has been at the heart of the company since its foundation, OPIS is fast establishing itself as a Biometry centre of excellence.
Qualified teams of Medical Writers, Project Managers, Statisticians, Data Managers, SAS programmers and a Clinical IT team work in synergy to provide high quality data management, biostatistics and e-clinical services to Sponsors from both the Pharma and Biotechnology industries.
At OPIS, scientific knowledge together with a broad experience in different therapeutic areas and indications as well as having validated in-house developed EDC technology, makes OPIS an ideal partner able to adapt to sponsor requests for different customized data handling processes flexibly.
An internally developed eClinical platform that unifies EDC with separate tools handling randomization (interactive response technologies), SAEs, protocol deviations and study drug management, helps reduce time in all stages from the “ready-to-go” to the final CSR.
Another competitive advantage is that OPIS has had a very low Biometrics and IT staff turnover and with no loss of efficiency due to changes in the team, this stability has allowed the company to establish solid cross-functional and cross cultural teams who take team and communication skills up a notch. Collaborator-client relationships are greatly enhanced as a result.
OPIS is competence at a competitive price.
For more information about OPIS and its services, please contact