Key Aspects to Optimize Site Management in Clinical Trials in Asia
Conducting clinical trials in Asia can provide benefits due to the unique regional features, but there are challenges related to diverse regulatory environments, legal issues, language or cultural hurdles, thus, site management must be one of the most important aspects to consider when planning your trial in Asia.
Based on our experience, there are 4 key considerations for an optimal site management when conducting clinical trials in Asia:
- Local team. It is essential to have the support of professionals capable of identifying the right sites, with knowledge about the regulatory landscape and potential pitfalls, who can advise correctly on the best strategy and highly skilled in cross-cultural communication.
- Strong working relationships. It will be important that CRAs are able to build strong bonds with the sites. As an example, frequent site visits will be necessary for SAE monitoring, IRB submissions, questions from the PI or for discussions with the PI about newsletters. Scheduling separate appointments with the PI and other site staff (e.g., IRB office, pharmacy) may also be required in some countries.
- Standards and expectations. Sites have high standards, which mean that they are generally compliant and collaborating well with the monitors and thus, for example, data base locks are in general a quite smooth experience, but it also means that sites have high expectations of CRAs, vendors and pharmaceutical companies.
- Low tolerability for issues. Sites expect that everything is working to perfection. For example, if the CRF can only be implemented after the FPI, a local CRA that has a strong connection with the site will be needed to explain and apologize to them and – crucially – to keep them motivated to continue with patient screening and enrolment.
Originally established in Japan, Linical is a global CRO which has actively expanded to become the first Japanese Headquartered CRO capable of delivering a one-stop service for large-scale projects, covering all key markets in Asia-Pacific. Linical has the experience, resources and know-how to successfully overcome the unique challenges of conducting clinical trials in Asia.
We offer our full-service capabilities and global reach but with an in-depth country specific expertise to ensure the success of clinical trials in main Asian territories
Learn more about why we are the right CRO for your studies in Asia here.