Biopharma Research & Development

PointCross provides the Biopharma industry with search-based applications, data integration and decision support solutions to generate new insights from R&D data, address drug safety concerns, compare efficacy, and solve regulatory/consortia data submission needs. Our informatics solutions increase productivity, address development issues, and accelerate decision-making by providing scientists with new ways of finding and discovering safety and efficacy signals sooner, and identifying/validating promising biomarkers across semantically integrated data and documents.

The underlying technology combines semantic normalization, metadata extraction, statistical and text analytics, and industry standard ontologies to enrich your data, discover relationships and uncover hidden patterns. Parametric and text-based search, information visualization, and collaborative workflows are provided to rapidly identify and share insights among scientists and regulatory personnel in tune with evolving industry initiatives.

We offer proven services to convert live and legacy nonclinical data from source systems and reports into submission-ready packages. Available formats include SEND (Standard for Exchange of Nonclinical Data) format for FDA submissions, SD (Structure-Data) files for the IMI eTox Initiative, or vendor-neutral de facto XML standards to support CRO-sponsor or partner data exchange.

Our clients include five of the top 10 global Biopharma companies. We have a longstanding CRADA (Cooperative Research and Development Agreement) with the FDA for the validation, visualization and review of regulatory submissions with controlled terminologies using ToxVision™ as part of the CDISC (Clinical Data Interchange Standards Consortium) SEND initiative.

Other Biopharma Solutions

In-licensing and Out-licensing solution for Biopharma and investment firms identify, assess, rank, and characterize their current portfolio and potential deals to make better decisions aligned with their strategy; conduct due diligence on deals and their financing; and achieve better value. The solution is offered as a standalone environment, or coupled with Competitive Intelligence facilities, Virtual Data Rooms (VDRs) and Data Exchange facilities to improve and accelerate deal execution.

Biopharma Virtual Data Rooms for collaborative environments to orchestrate interactions and data exchange with CROs, partners and/or regulators. Unlimited storage and secure transmission of data from your internal firewalls to an external Cloud hosted sites along with information authorization.

CRO Alliance Management for secure sponsor-CRO study lifecycle processes and data exchange capabilities through our SAS 70 certified hosted data center. Each party is able to work securely in their environment but they can slice sections of data and content that they wish to share selectively with others. The multi-party exchange automatically synchronizes this shared information with other participants. Industry standards for data exchange are supported in this environment.

Parenterals Database which includes relevant data points for thousands of excipients or additives approved by the FDA. This database is fully relational and searchable, simple to use, and self-explanatory.