Before expanding internationally, the pharmacy gained a solid understanding of the regulatory landscape in the US. To compound for international clinical trials, we work with contacts in the target countries to understand their regulatory landscape. This includes knowledge of local laws, regulations, and guidelines governing clinical trials, import/export of investigational drugs, and patient rights.Collaborating with regulatory consultants or experts in each target country is advisable.

We have established partnerships with local research organizations, hospitals, and academic institutions in the US to gain experience and can use our experience in various countries.These collaborations have provided access to facilities and experienced personnel. Local partners can also offer insights into cultural and logistical considerations that may impact the trial.

Different countries have diverse cultural norms, healthcare practices, and ethical standards.We research how to adapt and align with local values and regulations. This ensures that the trials are conducted ethically and in compliance with local expectations.

We account for logistical challenges related to drug shipment, storage, and distribution across borders.Language barriers, time zone differences, and potential travel requirements are all things we have experienced. Efficient communication channels have been key to our success with this.

Maintain consistent quality control across international trials to uphold the pharmacy's reputation and the validity of trial results.Implement monitoring mechanisms to ensure compliance with protocols and regulations.

As our pharmacy gains experience from compounding for international trials, we continue to refine our processes and share knowledge across our organization.We regularly update the team's understanding of international regulations and best practices through training and professional development.

After completing international trials, we gather feedback and insights to improve future endeavors.We have incorporated lessons learned into future trial planning and execution.