Name and address of company

Ikeguchi Holdings LLC, dba Akyrian Systems

109 Greene Street, Unit 3A New York, NY 10012

 

Describe the company’s business 

At Akyrian Systems, we leverage our years of experience in the clinical research field, to re-imagine processes that have historically led to long development times for Pharmaceutical drug development. 

 

People we have data for (clinical subjects, consumers, patients, investigators)

Akyrian Systems have data on company workforce, clinical study subjects and investigators.

 

Country these people represent

The clinical trial subject will represent the country within which their medical records are recorded as source documents for the study in which they are enrolled. Initially, we intent to conduct studies in the United States.
 

Forms of data 

All generated data will be in an electronic format.

 

Applications (software) that manage the data

The application Akyrian will manage data during clinical trials.

 

Location of physical data

Data will be managed in corporate headquarters located in the United States and, if applicable, in European Union.

 

Data storage and encryption

Data will be encrypted at rest in AWS RDS using 256-bit AES encryption. The database will handle data encryption and decryption and is accessibly only through the application and by Akyrian system administrators. 

 

Data Controller

Akyrian Systems is a Data Controller company. The data is owned by the sponsor of each clinical study.

 

Access to the data internal and external to the company

Internal workforce has accessed only as a system administration through the Akyrian application. 

 

Sponsors and their specified contractors will not have access to the Data unless they are contractually bound to adhere to the Akyrian Systems procedure, and written agreements. Any request to share Data, shall only occur if authorized by the individual in writing.

Authorized sponsor personnel will be able to download clinical trial data through Akyrian application user interface.

 

Workforce (Akyrian Systems employees) has limited access to the data

Workforces have no access to customer data on production environment. If data is shared, access is restricted to authorized individuals who have been allocated a password to allow access.
 

What Akyrian Systems do to the data 

Akyrian Systems collect the data and transfer it to the customers
 

Policy is shared with other parties

Akyrian Systems do not share data with other parties unless directed in writing by the sponsors and investigators who owns the data

 

Who we share that data with

Akyrian Systems ensures that Data are not shared unless sharing the data are carried out only to perform the applicable services required of Akyrian Systems and Sponsors and Investigators have consented to share the data.

 

How Akyrian Systems notify people that we have shared their data

Since Akyrian Systems does not share data, Sponsors and Investigators who have 

consented to share data shall notify the people that their data have been shared.

 

Obtain and revoke consent for the use of the person’s data

A person obtains their consent from their doctor. A person revokes their consent from their doctor.

 

Obtaining and revoking consent on non-adult data (up to 16 years old) 

A non-adult person’s legal guardian must obtain consent on behalf of the non-adult person

from their doctor. A non-adult person’s legal guardian must revoke consent on behalf of the 

non-adult person from their doctor.   
 

Request change, including deletion, of the data

Request can be made directly to the sponsor or investigator who, upon written notice to Akyrian Systems may authorize study subject request of this nature
 

Obtain a person’s data from Akyrian Systems upon request

A study subject may request an electronic copy of their data through their doctor (the investigator)
 

Data privacy statement and updates notification

All users of Akyrian will always have access to our latest privacy statement upon logging into the software.

 

Deletion of data when it is no longer needed 
Data will be deleted when specifically required by a client agreement or 5 years, whichever is longer.

 

Data breach/data stolen

An email notification will be sent to the persons affected by the breach. 

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Annual security review of this Data Privacy statement? 

Data Privacy Statement review will be performed on an annual basis. 
 

Akyrian Systems data protection

The Quality Assurance (QA) ensures Training, Internal Audit and Validation are in effect, current, and followed by Akyrian Systems workforce.

 

Data Protection Officer or equivalent

Rowena Rubio is the Data Protection Office (DPO)

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