Each country has its own rules and protocols for its clinical drug trials.
Operationally, however, drug trials, including foreign ones, follow a universal standard. “Good Clinical Practices” is the manual used around the world for clinical trials. (Administrative and legal forms vary from country to country.)
If the clinical trial is done well, then you can use those same steps in other countries. Protocols or documentation do not need to be rewritten. Much of the planning can be done internally.
Planning is the most important step in any clinical trial, regardless of the country. If it is not planned well, it will fail.
Multi-national drug trials have several planning steps to make it successful:
1. Plan your protocol so that is acceptable in other countries.
2. Plan your steps, manuals, project management so that is
workable in other countries.
Project launch is the one step where you can save the most time by planning it correctly. If not planned well, you lose lots of time and money.
DLTA, Drug Lifecycle Tracking Application maps the end-to-end drug approval process. It offers a one stop shop to manage Drug Lifecycle and Regulatory Review process. Contact us at (240) 753-8282 for more information.