Streamlined Clinical Development

The Streamlined Clinical Development (SCD) solution aims to establish optimized processes and systems for drug development that will help you take drugs to market faster, safer and cheaper. Currently, the clinical development phase is the most time consuming and costliest in the R&D process, with the average cost per drug being above $200 million, and time taken anywhere from 6-8 years. Causing, and/or contributing to the inefficiencies of the process are various issues such as:

· Difficulty in integrated clinical development planning
· Increasingly rigorous regulatory requirements and increased cost due to more complex trial requirements (e.g., more patients per trial, need to cover multiple populations & strata)
· Difficulty in patient recruitment
· Multiplicity of systems, poor site infrastructure, and lack of industry standards
· Accessing real-time, accurate trial data
· Lack of integrated view of Clinical, Lab and Safety data for the CRO as well as the Sponsor
· Complying with 21 CFR Part 11, GCP requirements
· Managing adverse event reporting
· Stringent FDA requirements
· Delays in submission and approval
· Large volumes of documents
· Difficulty in budget, resource, project management

The SCD solution addresses these 'pain points' by optimizing workflows, increasing real-time data access, and enhancing data quality & decision-making through the drug development value chain. The components of the SCD solution are:
· Domain and technical consulting spanning the development value chain
§ Process re-engineering for clinical research groups
§ Research-IT mapping to capture workflows and align supporting systems
§ Regulatory compliance consulting (21 CFR 11, CSV, cGCP, etc.)
· Clinical data management
§ Oracle Clinical - Version 4.0 & 4.5
§ Adverse event reporting systems
§ Remote data capture
§ Thesaurus management systems
· Document management
§ Workflow and lifecycle optimization
§ Content reuse to improve effectiveness
· Clinical trial project management
§ Customize horizontal project management platforms for clinical development
· Central lab management
§ Bid, Kit, Sample management, Study setup, Lab data management
§ Data validation for lab data
§ Integration with LIMS
§ Telemedicine data management and interpretation
· Pharma CRO integration
§ Trial status dashboard for the sponsor
§ Collaboration tools across Pharma-CRO interface
· Regulatory compliance
§ 21 CFR Part 11 compliance
§ Validation services - IQ, OQ, PQ
The SCD solution leverages Oracle and Documentation as preferred partners for specific components.