GS0411: Production and distribution of videos in the field of educational content for clinical research teams and participants regarding telehealth capabilities and best practices, phone or video visits, remote monitoring, in-home nursing and paramedics evaluations, workflows to support patient safety when participating remotely, technology recommendations, vendor evaluation, change management, and adoption of decentralized capabilities into clinical research workflows
GS0091: Downloadable computer software for disease and health condition management including self-management, specifically for use to monitor and input information relating to disease and health conditions and for reporting information in the medical, healthcare and clinical research fields; downloadable computer software for disease and health condition management including self-management, specifically for use to monitor and input information relating to disease and health condition and for reporting information in the medical, healthcare and clinical research fields; downloadable computer application software for use on portable communications devices, namely, mobile phones, tablets, handheld computers, laptop computers, netbook computers, namely, software for disease and health condition management including self-management, specifically for use to monitor and input information relating to disease and health condition and for reporting information in the medical, healthcare and clinical research fields; downloadable computer software for use in developing and customizing computer software applications and computer software application user interfaces; downloadable computer software for entering, storing, managing, tracking, analyzing and reporting data and content in fields of personally identifiable information, health, well-being, fitness, sports, diet, energy usage, personal finance, customer feedback, employee efficiency and personal productivity; downloadable computer software for facilitating communication between individuals and organizations, companies or third parties in relation to data and content collected and stored within the software
GS0051: Specimen collection kits for the collection of saliva, blood, urine, stool, nasal or pulmonary secretions, nail clippings, and hair strands comprised primarily of swabs for medical purposes and also including cups, bags, boxes, tubes, vials, and slides
GS0351: Business consulting and management in the field of clinical research, namely, recommending best practices for the implementation of decentralized capabilities; business advice related to the procurement and distribution of medical devices for clinical research and technology assessments and logistics workflows associated with the implementation of decentralized capabilities in clinical trials and remote care delivery services
GS0441: Providing medical information and health care services via the Internet or telecommunication networks; Remote monitoring of medical data for medical diagnosis and treatment; Remote phlebotomy services; Medical services, namely, intravenous (IV) infusion services; Laboratory services, namely, medical testing for diagnostic or treatment purposes; Providing educational information about healthcare for clinical research teams and participants regarding telehealth capabilities and best practices, phone and video visits, remote monitoring, in-home nursing and paramedics evaluations, workflows to support patient safety when participating remotely, technology recommendations, vendor evaluation, change management, and adoption of decentralized capabilities into clinical research workflows
DS0000: "CLINICAL TRIALS"
GS0101: Anatomic pathology specimen collection kit, namely, kits for the collection of saliva, blood, urine, stool, nasal or pulmonary secretions, nail clippings, and hair strands comprising cups, bags, boxes, tubes, vials, and slides
GS0421: Providing temporary use of online non-downloadable computer software for disease and health condition management including self-management, specifically for use to monitor and input information relating to disease and health conditions and for reporting information in the medical, healthcare and clinical research fields; providing temporary use of online non-downloadable computer application software for use on portable communications devices, namely, mobile phones, tablets, handheld computers, laptop computers, netbook computers, namely, software for disease and health condition management including self-management, specifically for use to monitor and input information relating to disease and health condition and for reporting information in the medical, healthcare and clinical research fields; providing temporary use of online non-downloadable computer software for entering, storing, managing, tracking, analyzing and reporting data and content in fields of personally identifiable information, health, well-being, fitness, sports, diet, energy usage, personal finance, customer feedback, employee efficiency and personal productivity; providing temporary use of online non-downloadable computer software for facilitating communication between individuals and organizations, companies or third parties in relation to data and content collected and stored within the software; Consulting services for others in the field of design, planning, and implementation project management of clinical research, namely, providing advice on clinical research design, protocol and consent language, storage and reporting methodology, participant expectations and considerations, and regulatory requirements; Conducting scientific research, clinical research for others relating to the development of digital biomarkers or endpoints to support improved patient care; Platform as a service (PAAS) featuring computer software platforms that permit users to identify, request and receive pharmacy products; Laboratory services and home health services, namely, medical testing for research purposes; Providing temporary use of on-line non-downloadable software for entering, storing, managing, tracking, analyzing and reporting data and content in the fields of personally identifiable information, health, well-being, fitness, sports, diet, educational development, energy usage, retail sales, customer feedback, employee efficiency and personal productivity; providing temporary use of on-line non-downloadable software for facilitating communication between individuals and organizations, companies or third parties in relation to data or content collected and stored within the software; computer services, namely, designing, developing, and maintaining computer software applications for others and consulting services related thereto; online hosted computer services, namely, designing, developing, customizing, and maintaining computer software applications for others and consulting services related thereto; Consulting services for others in the field of design, planning, and implementation project management of clinical research; Technical support services, namely, help desk services for IT infrastructure, operating systems, database systems, and web applications related to conducting of clinical research
Case File Event Statements
1/3/2024 - a year ago
1 - NEW APPLICATION ENTEREDType:NWAP
4/19/2024 - a year ago
2 - NEW APPLICATION OFFICE SUPPLIED DATA ENTEREDType:NWOS
7/31/2024 - a year ago
3 - ASSIGNED TO EXAMINERType:DOCK
8/7/2024 - a year ago
4 - NON-FINAL ACTION WRITTENType:CNRT
8/7/2024 - a year ago
5 - NON-FINAL ACTION E-MAILEDType:GNRT
8/7/2024 - a year ago
6 - NOTIFICATION OF NON-FINAL ACTION E-MAILEDType:GNRN
11/6/2024 - a year ago
8 - CORRESPONDENCE RECEIVED IN LAW OFFICEType:CRFA
11/6/2024 - a year ago
9 - TEAS/EMAIL CORRESPONDENCE ENTEREDType:TEME
11/6/2024 - a year ago
7 - TEAS RESPONSE TO OFFICE ACTION RECEIVEDType:TROA
3/4/2025 - 8 months ago
13 - APPLICATION EXTENSION TO RESPONSE PERIOD - RECEIVEDType:XELR