Pharmacovigilance (GVP)
Providing speedy and reliable pharmacovigilance service through our well-established team of highly skilled professionals in GVP operations
Our highly professional staff with extensive experience in GVP provide consultation as well as proposals that best meet the needs of our clients.
Our services ranges from registration, data entry, and QC to translation and preparation of evaluation drafts, and are available both on-site at the client’s office and through our data center.
We also provide services for various safety management information, such as receipt, entry, translation, preparation of draft evaluation (all including QC), and ACK confirmation after reporting to PMDA, depending on the situation such as full or partial.
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Service Features
- Point 1.
- Consignment system by well experienced professionals in pharmacovigilance.
- 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 PV consultation and IT system assistance.
Main Services with Details
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 case report form (draft) to PMDA ⇒ (adverse drug reactions, infectious diseases, medical device malfunctions)
- Prepare CIOMS (including Japanese to English translation)
Foreign country safety information service (post-marketing, 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 case report form (draft) to PMDA ⇒ (adverse drug reactions, infectious diseases, medical device malfunctions)
Other
- Establishment of known and unknown incidents for each drug
- 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 including remote working) services available
For further information on
Ark Medical Solutions Inc.If you have any questions or comments, please do not hesitate to contact us.
Contact UsArk Medical Solutions’s Scope of Service
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Clinical Development Support Services
From OTC products to ethical drugs and medical devices, we provide complete coverage of the healthcare market
- Monitoring
- EDC-enabled Data Management
- Biostatistics
- Medical Writing
- Auditing/Self-inspection
- EDC Services
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PMS Support Services
We provide various services to respond to the various PMS issues facing our clients.
- Patient Registration
- EDC-enabled Data Management
- Biostatistics
- Auditing/Self-inspection
- Medical Writing
- Auditing/Self-inspection
- EDC Services
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DB Research/DB Survey
A wealth of experience in using real-world databases
Comprehensive support for database surveys/database research by highly professional staffPharmacovigilance (GVP)
Providing speedy and reliable pharmacovigilance service through our well-established team of highly skilled professionals in GVP operations.
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ADDIN Series
ADDIN series, our EDC system which prioritize operability for physicians who are in charge of post-marketing surveillance, assures efficient and high quality data accumulation/progress management at your survey project.
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ePRO (Patient Reported Outcomes System)
We provide optimal ePRO system for collection of patient outcome data.
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Signal Management Service (Adverse Events Information Data Service)
We provide statistical analysis services for adverse event database systems and real-world data of various drugs by utilizing "FAERS" and "JADER," spontaneous adverse event databases collected/published by FDA and PMDA.