Recent and evolving laws, mandates and guidance by regulatory bodies and international health organizations necessitate that drug, biologics and medical device companies disclose greater amounts of clinical trial information. The goal is to achieve more transparency through the disclosure of clinical trial results and adverse events in publicly-available databases.
As a range of new medicines and medical devices are being developed, the focus on transparency and public trust has only intensified. World health officials and national regulatory authorities anticipate the global registries of clinical trials for new prescription medicines and devices will go a long way to allay public fears about the clinical trials process.
In order to satisfy the demand for clinical trials transparency, the industry is scrambling to come up to speed on what precise steps need to be taken to comply with these requirements. As an industry participant, you need reliable information to answer questions such as:
- What impact will new requirements have on our current processes, systems and infrastructure?
- What are the avenues for information to keep up to date with the evolving requirements/standards?
- What technology options are recommended for best practices?
To complicate matters, the disclosure regulations are often open to interpretation and vary from country to country and even from state to state until after 2010. What constitutes full compliance with the regulations, and how will you know if you are doing everything required?
In this white paper, you will learn how to distinguish between the various product and service offerings for clinical trial disclosure. You will also discover the best practices for improving the compliance process to satisfy current complex global transparency requirements and prepare for future regulatory directives.