The Process

Project management is the process of planning and managing resources to deliver on the project's scope within the time and cost constraints.

With project management techniques embedded into company's procedures, Probiotech OU will ensure professional execution of your next clinical trial.

Would you like to assure quality and consistency of your clinical data?

Probiotech OU runs its clinical operations in compliance with current FDA and ICH guidance on good clinical practice and the conduct of clinical trials. We place special attention to selection of clinical sites, fast patient enrollment, frequent monitoring visits and timely reporting.
Our clinical operations achieve the following clinical trial objectives:
  • Assessing clinical protocol feasibility
  • Selection of qualified investigators
  • Site evaluation and site initiation
  • Training site personnel
  • Ensuring proper investigational product storage and accountability
  • Monitoring data and verifying clinical records at site level
  • Assuring adherence to clinical protocol, good clinical practice and regulatory requirements
  • Accurate timely reporting and tracking of adverse events
  • Maintaining ongoing data entry and providing regular reports
  • Closing out study sites and ensuring records transfer
  • In addition, we provide a range of generic drug development services. Learn more about our Bioequivalence Services »
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We see Probiotech OU as an extension of our partner's team working together towards a common goal of bringing better medicine to the patients.
Would you like to complete your clinical trial on time and on budget?

Probiotech utilizes project management best practices to plan and execute Phase I-IV clinical trial projects. We specifically focus on defining the project charter, selecting leaders, training team members, and building project reporting tools.
Our project management process follows four phases with review and approval at the end of each phase:
  • Project initiation and start-up
  • Project planning
  • Project execution and management
  • Project close-out
Our project managers are trained to deliver on:
  •  Overall implementation of the clinical trial
  • Overseeing trial progress
  • Ensuring global communication
  • Regular reporting to sponsor
  • Managing timelines, budget and costs
Our vision for better medicine makes us learn and implement best practices that lead to the most efficient execution of clinical trial projects. 
 
We believe that by following best practices we meet our partner's needs in bringing better medicine to the patients faster.