serviceGVP

Providing Speedy and Reliable Pharmacovigilance Service through our Well-established team of Highly-skilled Professionals

Our highly professional staff with extensive experience in GVP provide consultation as well as proposals that best meet the needs of our clients. Our approach ranges from registration, data entry, and QC to translation and preparation of evaluation drafts. We can respond flexibly to our clients’ requests and are available both on-site at the client’s office and through our data center.

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Service Features

Point 1.
Well-organized and well-prepared team of professionals in pharmacovigilance and MD to meet your needs.
Point 2.
Proven and trusted brand to implement all projects from registration to evaluation draft preparation tailor-made to your requirements.
Point 3.
Ability to provide extensive and comprehensive support of pharmacovigilance from consultation and IT system assistance.

Services Provided for GVP

Domestic safety information service (post marketing surveillance, clinical trials)

  • Data entry to patient information safety database from safety management information reception
  • Prepare primary evaluation (draft), prepare follow-up research items (draft)
  • Prepare individual patient report (draft) to PMDA ⇒ (drug side effects, infectious diseases, medical device malfunctions)
  • Prepare CIOMS (including JPN to ENG translation)

Foreign country safety information service (post marketing surveillance, clinical trials)

  • Data entry to patient information safety database from CIOMS & Med Watch (including XML file acquisition) reception (provided by global business partners)
  • Prepare primary evaluation (draft)
  • Prepare individual patient report (draft) to PMDA ⇒ (drug side effects, infectious diseases, medical device malfunctions)

Other

  • Ascertain known & unknown incidents for specific drugs
  • Prepare evaluation (draft) from medical literature screening, prepare report (draft)
  • Consultation regarding safety information tasks

* On-site (stationed at client company office) and off-site (work from our company office) services available

Message from Pharmacovigilance Staff

My experience with CIOMS in a previous job was an opportunity to acquire in-depth knowledge of and experience in pharmacovigilance including collection, evaluation and safety information that I now put to good use at INTAGE Healthcare. This job requires me to have not only knowledge of drugs and diseases but also domestic and international regulations, which were a real challenge for me. The various internal and external training opportunities provided by the company as well as support from team members were a huge help for me.
I started my career in pharmacovigilance at a client’s office handling their communication with overseas offices and their compliance issues. Currently, I am responsible for safety evaluation.
Our department consists of an experienced staff who all have extensive consultation experience as well as firsthand knowledge from safety evaluation experience over the years. I believe this is one of our strengths and I am proud to be a member of the team. We gain new knowledge on a daily basis and strongly feel our contribution to a better society.

H.K. has 20 years of experience in Pharmacovigilance

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