Clinical Study Management
Clinical studies are complex endeavors that require a well-structured overall organization in order to meet regulatory and scientific requirements and timelines while sticking to a fixed budget and available resources. A well-designed protocol for a clinical trial may theoretically be able to answer research questions, but does not ensure success in practice if time as well as human and economic resources are managed poorly. Therefore, proper management is necessary to enhance the likelihood of the success of clinical trial projects.
Clinical trials need coordinated processes and activities, irrespective of size, scope, costs, or phase. Principal Investigators and Sponsors benefit from the help of an expert relieving them from the time-consuming task of management and coordination at the different phases of their project. Hence, we believe an effective management is a vital component of every successful clinical study!
As Clinical Study Managers, we oversee and coordinate the overall study conduct and ensure that every aspect of planning and execution is taken proper care of, from study conception to close-out. We make sure that milestones are reached within pre-set deadlines and budget as well as personnel constraints, while complying with Good Clinical Practice, applicable national and international regulations, scientific guidelines and standards, standard operating procedures, and not the least the study schedule and protocol requirements.
By fostering an open and effective communication between stakeholders (e.g. teams study sites, Sponsor, and other CTU divisions), we ensure that everyone is up-to-date and motivated to allow a steady and flawless conduct of the project through all its phases.
Our services include:
- Study design
- Study document development
- Trial Master File set up and maintenance
- Essential document collection and review
- Site preparation and initiation
- Site management
- Team management (internal and external)
- Submissions to ethics committees and regulatory authorities
- Patient recruitment and retention strategies
- Safety monitoring and reporting
- Timeline management
- Budget management
- Project status reporting
- Payment processing
- Risk mitigation and management
- Third-party vendor management
With a longstanding experience in the management of national and international studies of different size, length and complexity, the CTU Bern Clinical Study Management team offers competent and valuable help to investigators during the entire process of their clinical study in order to achieve success with a timesaving and cost-efficient performance.