Biostatistics
Our highly professional “biostatistics” team has the capacity to process vast amounts of data and can accommodate your needs.
Our professional experts with extensive experience deliver reliable data on the efficacy and safety of pharmaceuticals through precise implementation from statistical planning to final reports. Our ability to respond with flexibility to urgent requests, such as schedule changes and inquiries from regulatory agencies, ensures delivery of a high-quality product in an expeditious manner.
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Service Features
- Point 1.
- Project team of highly experienced professionals
- Point 2.
- Precise statistical plan through total study management to achieve goals
- Point 3.
- Efficient and high-quality analysis from academic experts and advanced SAS programming skills
- Point 4.
- CDISC-standard (SDTM, ADaM) compliant product
Main Services with Details
GCP and PMS
We prepare the following draft documents:
- Statistical analysis plan
- Specifications (e.g. diagram output specifications) and definition documents (e.g. analytical data)
- Analytical programs and validation
- Statistical analysis reports
- Assistance in responding to inquiries from regulatory agencies
- Consultations on overall biostatistics
GCP and more
- Support for preparation of protocol (e.g. in relation to biostatistics)
- Code-breaking meeting (e.g. immediate analysis result preparation)
- Pharmacokinetics parameters calculation
- CDISC-standard (SDTM, ADaM) data preparation
- Comprehensive project management of clinical trials
PMS and more
- Data confirmation materials
- Preparation of research paper materials for publication
Related Service
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Monitoring
Your clinical trials will be conducted in an accurate and seamless manner through implementation of our highly efficient and professional monitoring activities.
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Patient Registration
High-quality and speedy PMS patient registration center service based on our extensive experience.
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EDC-enabled Data Management
Highly professional and capable data managers provide high quality EDC-enabled data management services in an expeditious manner.
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Medical Writing
In our medical writing service, experienced and reliable professionals quickly respond to your project needs in full compliance with regulations and guidelines.
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Auditing/Self-inspection
An independent reliability assurance department audits all of our GCP, GPSP, and GVP services.
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EDC Services
Our extensive experience, expertise and lineup of system products provide full-featured EDC solutions.
(EDC system for post-marketing surveillance)
Our EDC System with speed, low cost and high-quality has been released
For more detailsFor further information onArk 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 staff
Pharmacovigilance (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.
