Clinical Operation requires expertise, accuracy, and speed as it is essential for the drug to get to market as fast as possible in order for the pharmaceutical company to receive a return on their initial investment and patients the availability of new drugs and treatments.
The key to success, when it comes to well-managed and -conducted clinical trials, is the implementation and execution of Quality Assurance (QA) principles throughout the lifetime of a trial. High- quality SOPs, processes that are thoroughly prepared and GcP principles are the foundation of which clinical trials should be built.
Both Statisticians and Data Managers are key people in the processing of reliable high-quality data and both must be involved in the project from the early planning to the final closing.
CroxxMed senior regulatory staff are used to navigating within cross-functional teams during the application process. Our regulatory team has extensive experience in advising, compiling, writing, and submitting applications and amendments to Competent Authorities as well as Ethics Committees.
We base our project management upon 5 essential processes: initiating, planning, executing, monitoring/controlling and closing. Project Managers at CroxxMed strive to manage your project, customized to your needs and desires.
Patient safety is a key component and imperative in all clinical trials – whether it’s drugs or devices and no matter how innovative, it cannot be registered and get to market unless proven to be safe. For all medicines, there is a trade-off between the benefits and the potential for harm.