The success of clinical trials largely depends on how effectively the sponsor's team interacts with the site teams.
With its expertise in clinical site selection, monitoring and reporting, Probiotech will ensure each site's safety and compliance with clinical protocol.
Would you like to assure quality and consistency of your clinical data?
Probiotech 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 »
Our vision for better medicine puts clinical operations at the core of our business. We believe that by focusing on clinical operations we deliver exceptional value to our partners.
We see Probiotech as an extension of our partner's team working together towards a common goal of bringing better medicine to the patients.