Research and Development remains the growth engine for pharmaceutical, biotech, biopharma and medical device companies. As the cost of bringing a product to market soars, budgets become more constricted, and the need for optimizing the research and development process becomes critical. Keeping patient needs first, while ensuring safe, efficient, yet cost effective clinical trials, increases the complexity of the data environments that support the process.
Global operations, the increase in CRO usage and other complex partner relationships require a collaborative approach to reach a successful product approval. Spanning the needs of scientific research, medical and patient relationship management, supply chain of clinical materials, surveillance and reporting, and medical and regulatory affairs, your research and development organization is a complicated environment operating under the tightest strictures of accountability. At the core of every step of the product development process is an interaction with information – studying a molecule, designing a trial, fulfilling a shipment, or delivering a safety report. Clinical organizations are awash in information needs and processes which are met with diverse practices and products.
At Knowledgent, our end-to-end approach for information management detangles the information flows, uncovers the vast expanse of clinical data stores, and provides solutions to organize, integrate, and deliver value from information assets. Our experience in information strategy, complex integration of structured and unstructured information, virtualized integration and real-time predictive analytics address the breadth of information needs in the research and development enterprise. Our strategic approach to information and process governance and stewardship provide an operational model for compliant data management, access and utilization. These approaches have been used on programs as diverse as biomarkers integration and analytics, site and provider recruitment optimization, Phase IV candidate selection and global safety report automation.
Our services include:
- Performance Management and Advanced Analytics – Developing analytical dashboards and reports to provide operational and strategic insight into the development process
- Process Harmonization/Optimization – Analyzing information processes and technology to optimize workflows, standardize processes across business units, or harmonize processes and technology across geographic boundaries
- Medical Communications and Knowledge Management – Optimizing the flow of medical information between internal and external stakeholders
By orchestrating the business, scientific and information processes within your R&D enterprise, our information-centric approach provides leveraged value across your organization and enables both the pipeline and revenue expansion of your growth engine.