Privacy Policy

ASSISTEK PRIVACY POLICY 

Effective Date: July 15, 2026

COLLECTION AND USE OF PERSONAL INFORMATION

Assistek, Inc. (“Assistek,” “we,” “us,” or “our”) provides electronic clinical outcome assessment (“eCOA”), electronic patient-reported outcome (“ePRO”), electronic consent, and related technology and support services for clinical research studies.

You may be asked to provide personal information through the Assistek website, an Assistek application, or an Assistek-supported clinical study system. The information collected depends on how you interact with Assistek and may include:

• Name, email address, telephone number, company, and other contact information;
• Information submitted through contact, registration, support, or inquiry forms;
• User account information and authentication credentials;
• Study-related information entered through an eCOA or ePRO application;
• Technical and device information, including device type, operating system, browser type, IP address, device or application identifiers, language settings, date and time of access, and application version;
• Connectivity information, including whether the device is connected through Wi-Fi, a cellular network, or another network and whether the device is online or offline;
• System activity, audit trail, synchronization, performance, error, and diagnostic information; and
• Other information necessary to provide technical support, maintain system security, validate system performance, or comply with clinical research and regulatory requirements.

Personal information submitted through the Assistek website is used for the purpose for which it is requested, including responding to inquiries, providing requested information, communicating with customers and prospective customers, and providing support.

Information collected through an Assistek clinical study system is used to operate and support the applicable clinical study, facilitate data collection, synchronize study data, troubleshoot technical issues, maintain security and audit trails, and satisfy applicable contractual, regulatory, validation, and recordkeeping requirements.

CLINICAL STUDY INFORMATION

When Assistek provides eCOA, ePRO, eConsent, or related services for a clinical research study, Assistek generally processes information on behalf of the study sponsor, contract research organization, healthcare organization, or other organization responsible for the study.

The study sponsor or other responsible organization determines the purposes for which study information is collected and used. Participants should review the study’s informed consent form and any study-specific privacy notice for additional information regarding the collection, use, disclosure, retention, and protection of their study information.

Assistek does not independently use clinical study information for advertising or unrelated commercial purposes.

AUTOMATICALLY COLLECTED AND TECHNICAL INFORMATION

Assistek systems may automatically collect limited technical information necessary to operate, secure, monitor, and support the website and Assistek applications.

This information may include:

• Whether the device is connected to Wi-Fi, cellular service, or another network;
• Network availability and connectivity status;
• IP address;
• Device type and operating system;
• Browser or application type and version;
• Device, session, or application identifiers;
• Login activity and access times;
• Data synchronization status;
• System performance and error information;
• Security logs and audit trail information; and
• Information needed to diagnose and resolve technical or support issues.

Assistek may use this information to confirm that study data has been transmitted successfully, support offline and online functionality, identify connectivity problems, protect against unauthorized access, investigate system errors, maintain validated system performance, and meet regulatory and contractual obligations.

Assistek does not use Wi-Fi or connectivity information to identify the specific websites visited by a user or to monitor the content of a user’s personal internet activity.

COOKIES AND SIMILAR TECHNOLOGIES

The Assistek website and applications may use cookies, session identifiers, local storage, or similar technologies that are necessary for authentication, security, user preferences, system functionality, and performance.

Assistek does not use these technologies to sell personal information or to build advertising profiles of clinical study participants.

Where required by applicable law, Assistek will provide notice or obtain consent before using non-essential cookies or similar technologies.

INFORMATION SHARING AND DISCLOSURE

Assistek does not sell personal information.

Assistek may disclose information:

• To the clinical study sponsor, contract research organization, study site, investigator, or other authorized study personnel;
• To service providers that support Assistek’s hosting, communications, technical support, security, data storage, or business operations;
• As necessary to provide the services requested by a customer or study sponsor;
• When authorized or directed by the individual, customer, study sponsor, or other responsible organization;
• To protect the rights, security, systems, property, or safety of Assistek, its customers, study participants, or others;
• To investigate suspected fraud, security incidents, or misuse of Assistek systems; or
• As required by law, regulation, court order, subpoena, warrant, governmental request, or other lawful process.

Service providers that receive personal information from Assistek are expected to protect the information and use it only for the services they provide to Assistek.

DATA RETENTION AND DELETION

Assistek retains personal information only for as long as reasonably necessary to fulfill the purposes for which it was collected or processed and to satisfy applicable legal, regulatory, contractual, clinical research, security, audit, validation, and recordkeeping requirements.

Retention periods may vary depending on the type of information, the nature and duration of the applicable clinical study or customer relationship, instructions from the relevant study sponsor or other data controller, and applicable laws and regulations.

When Assistek processes personal information on behalf of a clinical study sponsor, contract research organization, healthcare organization, or other customer, Assistek retains, returns, archives, or deletes that information in accordance with the applicable agreement, documented instructions from the responsible organization, the study protocol, the applicable retention schedule, and legal and regulatory requirements.

Upon expiration of the applicable retention period, personal information will be securely deleted, destroyed, returned to the responsible organization, or anonymized so that it can no longer reasonably be associated with an identifiable individual, unless continued retention is required or permitted by applicable law.

Personal information may be retained for a longer period where necessary to:

• Comply with legal, regulatory, clinical research, audit, validation, safety, or recordkeeping obligations;
• Maintain the integrity, reliability, and traceability of clinical study data;
• Establish, exercise, or defend legal claims;
• Investigate security incidents, fraud, or misuse of Assistek systems;
• Enforce contractual rights and obligations; or
• Support scientific research or other legally permitted purposes, subject to appropriate safeguards.

Individuals may have the right to request deletion of their personal information under applicable data protection laws. The right to deletion is not absolute and may not apply where continued processing or retention is required or permitted by law, necessary for clinical research integrity or regulatory compliance, or necessary for the establishment, exercise, or defense of legal claims.

Requests involving information collected as part of a clinical study should generally be directed to the study site, investigator, study sponsor, or other organization identified in the applicable informed consent form or study-specific privacy notice. Where Assistek receives such a request directly, Assistek may refer the request to the organization responsible for determining how the information is processed.

Assistek will remove personal information from active systems in accordance with its documented retention and deletion procedures. Information contained in encrypted backup, archival, or disaster-recovery systems may remain until the applicable backup or archive expires under Assistek’s established retention schedule. Such information will be protected from routine access and use and, if restored, will remain subject to the applicable deletion requirements.

Assistek takes reasonable steps to require service providers and subprocessors that process personal information on its behalf to return or securely delete the information when their services end or when instructed to do so, unless continued retention is legally required.

Assistek may maintain limited records of deletion requests and completed deletion activities where necessary to document compliance, without retaining more of the deleted personal information than is necessary for that purpose.

CONFIDENTIALITY AND SECURITY

Assistek maintains reasonable administrative, technical, organizational, and physical safeguards designed to protect personal and non-personal information against accidental or unlawful loss, misuse, unauthorized access, disclosure, alteration, or destruction.

These safeguards may include access controls, authentication, encryption, system monitoring, audit trails, security policies, employee training, vendor oversight, backup and disaster recovery procedures, and validated system-development and change-control processes.

Access to personal and study information is limited to authorized individuals who require access for legitimate business, technical support, clinical study, regulatory, or legal purposes. Assistek personnel are required to comply with applicable confidentiality, privacy, and information-security requirements.

No electronic system or method of transmission is completely secure. Accordingly, Assistek cannot guarantee the absolute security of information transmitted to or maintained within its systems.

INTERNATIONAL DATA TRANSFERS

Assistek may provide services for clinical studies conducted in multiple countries. As a result, personal or study information may be processed or stored in countries other than the country in which it was originally collected.

Where required, Assistek and the organization responsible for the study will implement appropriate contractual, technical, or organizational safeguards for international transfers of personal information.

PRIVACY RIGHTS

Depending on the individual’s location and applicable law, individuals may have rights regarding their personal information, including the right to request access, correction, deletion, restriction, or a copy of certain information.

Individuals may also have the right to object to certain processing, withdraw consent where processing is based on consent, or submit a complaint to an applicable data protection authority.

For information collected as part of a clinical study, requests should ordinarily be directed to the study site, investigator, study sponsor, or contact identified in the informed consent form or study-specific privacy notice. Assistek may refer a request to the organization responsible for the applicable study.

Assistek will respond to privacy requests within the period required by applicable law. Assistek may need to verify the identity and authority of the person submitting the request before taking action.

Certain information may not be subject to deletion or modification where retention is required for clinical research integrity, audit trails, regulatory compliance, legal obligations, public health or safety purposes, or the establishment, exercise, or defense of legal claims.

CHILDREN’S INFORMATION

Assistek’s general website is not directed to children. Assistek does not knowingly collect personal information from children through its general website without appropriate authorization.

Where an Assistek system is used in a pediatric clinical study, information will be collected and processed in accordance with the applicable study protocol, informed consent or assent process, sponsor instructions, and applicable law.

CHANGES TO THIS PRIVACY POLICY

Assistek may update this Privacy Policy from time to time as its products and services change, its technology develops, or legal and regulatory requirements evolve.

When material changes are made, Assistek will post the revised Privacy Policy on its website and update the effective date. Where appropriate or legally required, Assistek may provide additional notice regarding material changes.

CHANGES IN CORPORATE STRUCTURE

If Assistek or all or part of its business is sold, merged, reorganized, financed, acquired, or otherwise transferred to another organization, information maintained by Assistek may be disclosed or transferred as part of that transaction.

Assistek will take reasonable steps to require that transferred information continue to be handled in a manner consistent with this Privacy Policy and applicable legal, contractual, and clinical study requirements.

CONTACT INFORMATION

Questions concerning this Privacy Policy, Assistek’s privacy practices, or requests concerning personal information may be submitted through the contact information provided on the Assistek website or to:

Assistek, Inc.
2005 S. Easton Road, Ste 203, Doylestown, PA 18902
Email: support@assistek.com

Individuals located in the European Economic Area or United Kingdom may also have the right to submit a complaint to the data protection authority in the country where they live, work, or believe a violation occurred.