Privacy Policy

Definition of Terms

"Personal Data" means any data or combination of data that could potentially identify a specific individual and includes information such as Name, Email, Address, or any other data that could be linked to a particular person.  Personal Data does not include information that is stored in an anonymized format or is otherwise publicly available.

"Sensitive Data" pertains to data that reflects racial or ethnic origins, health, or sexual orientation and activities.  Clinical research studies often collect data categorized as "sensitive", however, a requirement of clinical research (Good Clinical Practices (GCP)) requires that enrolled subjects have completed and signed an Informed Consent (IC) that notifies them of the requirements of the study, including the data (personal and sensitive) that will be collected and processed as a part of the study conduct.

"Clinical Study Data" means the specific details of an identifiable individual with respect to medical history, prescription drug use, clinical observations or test results and other medical records.  Personal Data may also be considered Clinical Study Data if collected for the purpose of conducting a clinical trial.

Clinical Ink intends that its corporate privacy policies and internal SOPs and work practices are adequate to ensure compliance with applicable international laws and regulations including the US Health Insurance Portability and Accountability Act (HIPAA), the European Union’s Data Protection Directive (EUDP), and other similar guidelines.  We have developed our policies related to data collection, security and privacy in a manner consistent with the requirements of the applicable laws and regulations of the countries in which we operate. 

Privacy Policy Principles

The Clinical Ink Privacy Policy is based upon the following Privacy Principles:

NOTICE:

In all cases where Clinical Ink is acting on our own behalf, such as with employee or customer Personal Data, the collection vehicle will specifically provide notice stating the purpose for which the information is being collected and how that information will be stored.  As a Software-as-a-Service (SaaS) provider of clinical trial software and services, Clinical Ink acts as an agent on behalf of clients to collect Clinical Study Data.

With respect to all Clinical Study Data, Clinical Ink shall act in a manner governed by the contractual relationship with each customer consistent with the notice provisions specified by the customer in their relationship with the individuals participating in the clinical study.  Clinical Ink will disclose all information regarding how Clinical Study Data is secured in order to facilitate customer’s Notice responsibilities.

CHOICE:

Clinical Ink will not share Personal Data with third parties except in cases where the third party is acting on behalf of Clinical Ink consistent with the purposes for which such Personal Data was originally obtained.  All Clinical Study Data is owned by our customers who retain the responsibility to permit individuals to withdraw consent to have their personal Clinical Study Data used for purposes other than for the originally intended purpose.

ONWARD TRANSFER:

Clinical Ink may share Clinical Study Data with agents, third-parties, or partners approved by our customers and as required by contract.  Clinical Ink will not disclose any Clinical Study Data to third-parties without explicit approval from our Customer.  In cases where Clinical Ink contracts with a third-party, we will obtain assurances that they will safeguard Personal Data and Clinical Study Data in a manner consistent with this Policy.

SECURITY:

Clinical Ink will employ reasonable safeguards to protect Personal Data from loss, misuse, unauthorized access, disclosure, alteration and destruction.  Clinical Ink strictly controls access to Clinical Study Data through multiple security mechanisms and adheres to a Defense-In-Depth approach with regard to data security which includes the following:

• multiple physical data center security controls,
• physical server rack controls,
• environmental monitoring,
• anti-virus software,
• permit-only firewalls,
• database logging and auditing,
• multi-factor authenticated VPN,
• encrypted communications,
• anonymization of certain data elements.

DATA INTEGRITY:

Clinical Ink facilitates the collection of Personal Data and Clinical Study Data as specified by our customer.  Customers must also receive the appropriate regulatory and oversight approvals (e.g. FDA, EMA, Institutional Review Boards, etc.) necessary to conduct the clinical trial.  Clinical Ink does not own or have any rights to any Clinical Study Data and makes no decisions based on such data. 

ACCESS:

Clinical Ink will facilitate any Access requests, made by a clinical research participant, received by our customer in the course of fulfilling our contractual obligations to collect and store Clinical Study Data.  Clinical Ink does not work directly with clinical trial subjects or investigative sites to correct/modify Clinical Study Data.  With respect to Personal Data maintained solely on behalf of Clinical Ink, upon request we will provide reasonable means to ensure such data is accurate.  In particular, our employees have a responsibility to ensure that all Personal Data is updated regularly as changes occur.

ENFORCEMENT:

Clinical Ink will fully cooperate with all customer requests to investigate potential violations related to Clinical Study Data.  Individuals, including employees, who feel that Clinical Ink has violated this Policy in any way, may contact the head of Quality & Compliance directly to initiate a formal inquiry.  Employees found willfully disregarding this Policy shall be terminated.

Verification

Clinical Ink has specifically designated the head of Quality & Compliance to oversee adherence to this Privacy Policy.  This Policy is reviewed by Clinical Ink management, at a minimum, biennially; however, it may be revised at any time.

Dispute Resolution

Clinical Ink shall work directly with affected individuals and customers to resolve all complaints and disputes regarding the handling of non-employee Personal Data and Clinical Study Data in accordance with the principles outlined in this Policy.  Unresolved complaints may be referred to the American Arbitration Association for resolution pursuant industry standard practices.  Disputes involving the handling of employee Personal Data shall be handled through an internal review process according to the severity of the complaint.

Reservation of Rights

Clinical Ink reserves the right to share Personal Data as required by law in order to respond to duly authorized information requests of government authorities.  For such requests involving Clinical Study Data, Clinical Ink shall provide notice to affected customers, but shall not necessarily seek permission, prior to disclosing any data to regulatory agencies.

Contact Information

Clinical Ink welcomes your comments regarding this privacy statement. If you believe that Clinical Ink has not adhered to this privacy statement, please contact us by phone, electronically or via postal mail at the following address, and we will use commercially reasonable efforts to promptly determine and remedy the problem:

Clinical Ink

525 Vine Street, Suite 130
Winston-Salem, NC 27101
Tel: 1-336-714-7402
Fax: 1-336-922-1707