service
A comprehensive support service to run clinical studies and research, as well as epidemiological study, post-marketing survey and pharmacovigilance is provided in a timely and professional manner, while your request of single operation service such as “monitoring” or “data management” itself is also met. We respond and propose the best solutions flexibly to meet your needs.
Support customers to solve their issues with abundant achievements, knowledge, and advanced nature
In clinical development (GCP), we efficiently conduct clinical trials and contribute to the success of projects, including support from regulatory authorities prior to the start of clinical trials. In support of post-marketing surveillance (GPSP/GVP), we make proposals in response to various requests by utilizing our own digital solutions based on EDC in project management from the survey planning stage to re-examination application and support of conformity audit. We also flexibly respond to specific clinical studies, observational studies, investigator-initiated clinical trials, academic support, etc., such as establishment of the study system, support for secretariat and preparation of protocols, monitoring, DM/EDC, analysis, and clinical study reports.
Service area of CRO
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Corresponding area
- Clinical trial
- Investigator-initiated clinical trial
- Post-marketing surveillance
- Specific clinical study
- Observational study
- Other
- Database research/survey
Corresponding field
- Pharmaceuticals
- Medical devices
- Regenerative medicine and other products
- Rare diseases
Ark Medical Solutions’s Scope of 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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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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Biostatistics
Our highly professional “biostatistics” team has the capacity to process vast amounts of data and can accommodate your needs.
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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.
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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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Biostatistics
Our highly professional “biostatistics” team has the capacity to process vast amounts of data and can accommodate your needs.
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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.
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DB Research/DB Survey
Comprehensive support for database surveys/database research by highly professional staff, utilizing our knowledge and experience in use of real-world databases.
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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.
Experience by Therapeutic Area
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| Central Nervous System | 33 | Sense Organs | 23 | Cardiovascular | 51 |
|---|---|---|---|---|---|
| Respiratory Organs | 7 | Digestive Organs | 23 | Urogenital/Anal | 6 |
| Dermatology | 13 | Blood/Body Fluids | 9 | Metabolic Diseases | 61 |
| Diabetes | 51 | Neoplasm | 56 | Antibiotics | 13 |
| Chemotherapeutics | 13 | Medical Device | 23 | Others | 47 |
Our Approach to Quality Improvement
We give top priority to reliability assurance and deliver products that meet a specific level of quality when collecting information and preparing documents for all kinds of applications. We strive to improve the quality of our service by thorough compliance with SOPs, saving records and trails, and intensive education and training. We are also committed to developing awareness about the data and value of our products.
<GxP Quality Policy>
Increase customer satisfaction by understanding customer needs and expectations, and continuously recommending and providing improvement and creativity.
- Customer needs and expectations go beyond what they tell us. We must rid ourselves of stereotypes and be acutely aware to discover a customer’s true needs and link this understanding to improvement and creativity.
- Quality is not for us to define by our standards. Quality is defined by satisfying customer needs. We should enhance customer loyalty by continuously making proposals that anticipate their needs.
For further information onArk Medical Solutions Inc.
If you have any questions or comments, please do not hesitate to contact us.
Contact UsRelated information
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COMPANY
Ark Medical Solutions company information: Mission statement, company overview, etc.
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RECRUIT
Ark Medical Solutions is the very stage for “star players” and “business leaders” who possess individuality compassion, and professionalism, and for people who continue to put forth aggressive efforts to open the way to the future.
