Post-Marketing Surveillance Operation

The importance of Post-Marketing Surveillance has being increasing more and more and ASKLEP is one of the leaders in PMS Studies in Japan. For over quarter of a century, we have conducted these studies under the strict guidelines of GPMSP. We have integrated our advanced ICT solutions including EDC into our PMS offerings allowing us to manage large-scale studies, handling massive amounts of data while maintaining the highest of quality and efficiency.

ASKLEP’s Advantage

Service overview

FAQs

Can you support monitoring for PMS?

It depends on the availability of resources. In some cases we will be able to do so in collaboration with our Clinical Research Division.

How many clients do you have?

On average we are doing business with 20 to 25 companies on an annual basis. We request our clients to complete a “Customer Satisfaction Survey” which indicates more than 70% of our clients are satisfied with our services.

 

Our Experience

Can you dispatch staff members in a specified dispatch contract?

No, in general, we do not normally dispatch our staff outside.
However, we may do so in order to enhance our partnership with the sponsor.

Why did you open Ikebukuro Office in 2011?

We had two bases, Hibarigaoka office and Akihabara Head Office for our PMS business, but our business expansion required more floor space which led us to open  Ikebukuro Office. New Ikebukuro Headquarters has consolidated all PMS-related functional units and will enable us to provide even higher-quality services.

Describe over a quarter-of-a-century experience.

Our PMS business started in 1986 and has responded to various forms of studies and surveillance. So, we have accumulated a lot of know-how.

Do you have experience with large-scale studies?

Yes, ASKLEP has conducted more than 10 large-scale studies involving more than 10,000 subjects, in each.

How long will it take to set-up EDC for a study?

Depending on the protocol but generally, it takes about three months to develop basic functions.

Why did you develop your own EDC?

We felt there was a need in Japan to develop a robust EDC system for PMS studies that is user-friendly for physicians, sponsors and CROs.