Monitoring
Your clinical trials will be conducted in an accurate and seamless manner through implementation of our highly efficient and professional monitoring activities.
Service Features
- Point 1.
- Project management by capable project leaders well-versed in GCP.
- Point 2.
- High-quality service by our integral team including data management and biostatistics to fulfill your application targets.
- Point 3.
- RBM approach (placement of persons with experience in RBM studies, appropriate building in quality (BiQ), risk detection/prevention effects by selected KRIs)
Main Services with Details
- Consultation throughout the entire clinical development
- Management of overall clinical trial projects
- Clinical trial coordinating secretariat duties
- Support for preparation of protocol (draft)
- Support for preparation of subject informed consent form (draft)
- Support for preparation of investigator’s brochure (draft)
- Feasibility studies
- Selection of clinical trial sites
- Handling of contracts and requests for clinical trials
- Collection and shipment of investigational drugs
- Management of cases and progress of the project
- Direct access and SDV
- CRF collection and data cleaning
- Termination proceedings for clinical trials
- Process-focused QC activities
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
-
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
-
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
-
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.
-
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.
-
ePRO (Patient Reported Outcomes System)
We provide optimal ePRO system for collection of patient outcome data.
-
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.