- Maximize ROI of technology and human capital investments
- Achieve operational efficiencies in conducting clinical studies
- Establish a robust framework for all future studies
- Enable “real-time” or “timely” decision making
- Reduce re-work and process redundancy
- Create role-based flexibility that anticipate obstacles
- Increase global clinical research and development capacity
- Minimize regulatory risk through quality assurance
- Build standards and feedback loops for continuous improvement
People, Process, and Technology
Soltex Consulting takes a holistic approach to process analysis, design, authoring, and implementation to develop a set of global procedures that will best utilize your people and technology. Process re-engineering requires a flexible and individualized approach tailored to your organization. We know how to strike the balance between accommodating existing procedures and aggressively working on change management. The end result is a set of processes that will help you realize increases in efficiency, capacity, and quality across all workflow areas.
Customizable Clinical Trial Solutions
Process re-engineering takes creativity and rigor in the development of innovative and streamlined workflows. We take a four-step approach to addressing the unique challenges you face in driving efficiencies throughout the clinical trial lifecycle:
"The time that Soltex Consulting took to understand our working processes and our culture made us feel confident that we would be working towards our company vision."– Soltex Consulting client
Process re-engineering begins with a rigorous analysis of current processes to help clarify your requirements and align our work with organizational goals and company culture. The analysis includes the creation of a process map that provides a high level visual display of the workflow that study teams can easily react to and understand. The process map will identify bottlenecks, discover interdependencies, define the role of each process, and inform our understanding of the desired future state.
Soltex Consulting believes the best approach to process design is to begin with the end in mind. Great care is taken to ensure that the design of future processes reflects your vision, values, and goals.
Well-designed processes are harmonized, role-based, and documented. Harmonized processes reduce complexity and duplication, but there must be a level of flexibility to adapt to local needs and to avoid over-engineered instructions. Role-based processes better support resource interchangeability, scalability, and flexibility. Documentation facilitates the proper execution of tasks and makes it easier to train new study team members.
Our philosophy towards process authoring is that all processes must pass the test of being clear, concise, and relevant while minimizing regulatory risks and maximizing efficiencies. Working within the framework and guidelines set during the design phase, we employ our extensive process-authoring experience to create detailed process documents. We work to create standard operating procedures (SOPs) and other supporting documentation including best-practice guidelines and job aids.
If you’re like most companies we’ve worked with, a lack of consistent processes is the first source of inefficiency that can be addressed to drive individual project teams to operate consistently against the same workflow, systems, and roles. Instead, each project team develops and defines its own process. Together, this lack of unified, standard processes causes inefficiencies and confusion for resources working across projects and across geographies as well as a lack of ability to gather and report on metrics for management oversight. Multiple clinical trials can be efficiently managed once you establish a single set of standard operating procedures that have been harmonized across the entire organization.
We recognize that implementation of new processes is just as important as designing the right ones. Our core philosophy of integrating people, process, and technology informs our approach to process implementation. We offer a suite of services to help guide you through everything from ensuring appropriate access and approvals to your overall deployment strategy.
As your organization changes, so too must your processes. Monitoring and continuous improvement help you continue to improve upon existing processes, update documentation, and drive new efficiencies as your business needs demand them. We will help you establish “A Single Source of Truth,” by creating views of key operational data for all team members. The proper trending, analysis, and reporting tools positions you for successful clinical trial management.