ASKLEP provides support services for safety information so that the sponsor’s burden can be reduced significantly allowing Sponsor’s to utilize their resources more efficiently and to their fullest.

Our professional staff help you collect, assess and analyze safety information during a clinical trial and post-marketing study by broadly utilizing our know-how that we have accumulated as one of the first CROs in Japan. We conduct high quality pharmacovigilance in data entry, preliminary assessments and quality checks. Our support services listed below will meet your pharmacovigilance needs.

Service line-up

  • Relating to domestic safety information:
    1. Enter safety information and make preliminary assessments in relation to safety.
    2. Undertake quality checks of entered safety information.
  • Relating to overseas safety information:
    1. Enter safety information collected from CIOMS/ MedWatch and make preliminary assessments.
  • Draft reports to PMDA (E2B/M2):
    1. Prepare draft case reports on adverse reactions, infections, etc., for drug and medical devices.
  • Other related services

Our Advantages

  • ASKLEP is prepared to provide a full line of safety information support for clinical trials and post-marketing studies.
  • Highly experienced in MedDRA and MedDRA coding.
  • Based on our medical expertise, ASKLEP is able to quickly assess and respond to unexpected and serious adverse events.

PMS Consignment

PMS

GCP Consignment

GCP