Orpine Systems specialises in providing a range of clinical data services with coverage from clinical data management to regulatory submissions. Our statistical programming and biostatistics unit supports clinical drug development across several therapeutic areas and several phases of studies, with a special focus on oncology. We are uniquely differentiated and have earned a reputation for high-quality deliverables at very high productivity levels while being competitive and flexible in our delivery models.
We are a Registered Solutions Provider of CDISC (Clinical Data Interchange Standards Consortium) and understand the necessity of data standardization from collection through submissions. Our team understands the CDISC SDTM and ADaM data standards extremely well and we have tremendous experience in working with several sponsors in implementing their own interpretation of data standards.
Our Functional Service Provider model or the Fixed Price model enables us to be highly flexible and respond rapidly to customer requirements. Our deep domain expertise, process understanding, and technology capabilities in partnership with Oracle and select strategic partners enable us to deliver transformational results and better outcomes for sponsors.
Capabilities
Business Benefits
Our years of experience working with several bio-pharmaceutical companies and our knowledge of cutting-edge technology solutions allow us to make recommendations on right-fit CDM solutions
Access to a multi-disciplinary team with extensive knowledge and experience in working with sponsors and regulators
Our flexibility in working with sponsors on FSP with dedicated teams as well as Fixed Bid models with access to US-based infrastructure via our boutique CRO subsidiary, ACI Clinical (Applied Clinical Intelligence)
Our ability to step up during crunch times and work alongside sponsor’s teams to enable mission-critical submissions to regulators
With Orpine Systems you can expect: