Process Assessment, Pharma and Device
Working with the cross-functional leadership in a large pharmaceutical and device company, CrossPhase developed a personalized workshop approach to assess each function's processes, including collaborative handoffs and cross-functional processes. Workly quickly from best practices processes and illustrations, the outputs were future-state processes, technology-adoption opportunities and a prioritized list of areas where process and technology investments could provide bigger, faster ROI to the organization.
Product Safety Process Assessment
CrossPhase has been involved in several process assessments for product safety and surveillance organizations, from small biotechnology organizations to large CROs. From case intake, triage and processing through ICSR reporting to international regulatory authorities, we have been able to assist organizations with improving compliance and quality in safety while mapping a route to allow organizations to spend less time on being concerned with basic obligations and more time on proactive use of safety data.
eTMF Implementation
CrossPhase has helped many customers select and implement an appropriate eTMF solution to fit the needs of their regulatory and clinical study teams based on study complexity, budget and document management models. eTMF solutions have grown substantially in capabilities and can enhance and enable processes from study-startup through inspection readiness. At the same time, some organizations don't require the complexity that some solutions offer. We've helped select the right solution based on requirements, budget and direction. We've also fast-tracked implementations based on best practices and a library of reflective SOPs.
CTMS Implementation
CrossPhase has assisted in the implementation of CTMS' for over 20 customers, from global Oracle Siebel CTMS implementations to smaller solutions targeted for startup organizations. CTMS is the project management tool for clinical studies and is a powerful solution to tracking critical study and site-based milestones across study phases. We have successfully helped customers select CTMS solutions to fit their requirements and create implementation plans that are achievable and follow a prioritized strategy for them.
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.
Clinical Study Management Platform Selection
Working with the leadership team of an non-profit CRO, we developed prioritized requirements for data capture, data management, clinical trials management and document management. We organized these requirements into an evaluation strategy for components of the clinical operations and study execution platform. The RFP and scorecard strategy allowed the customer and each of the stakeholders to evaluate components based on functional goals and requirements and select the appropriate solutions to support their study and operations strategies.
Drug Safety Platform Implementation
Working closely with clients, we've helped customers evaluate their strategy for supporting case processing and reporting based on their development strategy, regional and international product representation and partner strategy. Based on case volume, regulatory obligations, product maturity and partner models, we've helped them select the right platform and configuration strategy to fit and position them for growth, internationally and as products enter the market. We are very experienced in safety data exchange, E2B, distributed case processing, licensing partnerships and all the influences on today's complex drug and product safety ecosystems.