We offer expert consulting and program management to include:
Strategic Alignment
Our customers often have a very good idea of where they want to go. We help them with developing the steps to get there including prioritizing partnerships, organizational investments and technology implementation.
Process Assessment and Design
Using engagement techniques like customized workshops, interviews and review of existing documentation, CrossPhase develops a path from where clinical, safety and regulatory processes are and where they could be. Our goal is to develop an iterative, achievable path to an innovative, industry-leading future state. If you're organization is just starting, implementing best practices can accelerate the path to success.
Data and Analytics Strategy
Research data has grown beyond electronic data capture (EDC) and reporting. Innovative study designs require a strategy for collecting and integrating lab, data direct from subjects (ePRO and eCOA), as well as imaging, ECG and other health data. Knowing what is important in this data stream and how to present it meaningfully to the right audience is our approach to developing and implementing a data and analytics strategy. Developing a practical path as well as selecting appropriate partners are attributes to success with clinical data.
Document Management Strategy
Clinical research and supporting processes still rely on production, storage and the ability to quickly retrieve paper and electronic records. CrossPhase can review or create your document management strategy to ensure you have well-defined policies and procedures for document management and supportive technologies, to include eTMF, quality system documentation, regulatory submissions documentation.
Platform Selection
We're versed in, an track industry-leading technology providers and can help evaluate and select from a number of technology providers for document management, data management and analytics. We have success in helping develop the right selection process, including RFP design, scorecards for solution candidates and evaluation of solutions based on practical use cases.
Change Management
Adoption and ownership of changes requires good planning and execution of change management and communications efforts. We're fans of embedded change management, beginning when we engage with business teams to discuss goals and objectives for process and technology efforts. Change management is carried through implementation planning, execution and post-implementation hypercare to make sure change takes root and positively impacts the organization.