Services & Solutions Planning
Plan with the end in mind, and be prepared for any hurdles en route to a successful program. Start-up
Getting out of the gate fast and with confidence will set the right tone for the entire project. Execution
The right people, resources and strategy will positively affect performance results. To increase the operational success of your clinical programs, you need experienced professionals who provide customized plans and solutions that are cost-effective, compliant and practical. Clinical Research Planning
Clinical trial planning is critical to successful clinical trial execution. We offer executive level development planning, operational implementation and oversight of your clinical programs. We customize comprehensive and proven tools that translate your development and program strategy into clinical operations management plans.
Program / Project Management
In order to keep study deliverables on time, on budget and regulatory compliant, clinical programs require experienced oversight by appropriately qualified individuals. As a seamless member of the sponsor team, we provide expert clinical operations management to see your program through to completion. Having key clinical trial information available at your fingertips is vital to assuring your programs stay on track. We help you to develop the appropriate metrics, reports, and dashboards that align with your business processes and information needs.
Vendor Management
The ultimate responsibility for the quality and integrity of the trial always resides with the sponsor. We provide you with the guidance, tools, and resources necessary to source, select, and oversee CROs and technical vendors, to help fulfill your oversight obligations.
Inspection Readiness
The sponsor is responsible for implementing quality management systems to ensure compliance with the protocol, GCP and applicable regulatory requirements. We work with you to develop customized:
• Standard Operating Procedures • Study Team responsibility matrix and job descriptions • Training plans and documentation Clinical Operations Model & Infrastructure Development
Costs associated with the drug development process have increased steadily over the last decade, increasing risk and with it, the need for more efficient use of money, time and people. We work as your clinical operations team to optimize your resources and bridge the program and project management gaps as you grow your pipeline.
| ||||||||||||||||||||||||||
