FMD K&L can assist with ensuring that global trials meet all local regulations for archiving.
Good Clinical Practice (GCP) specifies that both sponsors and investigative sites must retain essential study documents and databases in accordance with local regulatory requirements. GCP suggests that data and documents be retained for at least 2 years beyond the last approval of a product’s marketing application or until 2 years following discontinuation of the product’s clinical development.
Local regulations, however, may require a longer period of archiving. For example, the Finnish Medicines Agency requires 15 years of storage after the end of a clinical study. Understanding the many local archiving requirements inherent in a large, multinational study can be challenging.
We can provide an end-to-end archiving solution covering every stage of the clinical trial lifecycle. Our archiving experts determine the requirements of every regulatory agency involved in your study and recommend a global archiving facility capable of meeting your requirements.