Information for Sponsors

Sponsors interested in collaborating with the Kaiser Permanente Northern California Clinical Trials Program (KPNC CTP) should submit a request through the Research Collaboration Portal. This portal serves as the primary entry point for initiating partnerships, allowing sponsors to connect with KP researchers, share study proposals, and begin the process of collaboration.

The KPNC CTP team will review submissions and coordinate with the appropriate legal, administrative, and clinical teams to support contract negotiation, protocol evaluation, and study setup.

The time it takes to negotiate a budget or contract can vary widely depending on several factors. While CTP aims to align with industry standards and drive toward our “Drive to 90” goals, negotiation timelines are influenced by a range of considerations such as fair market value assessments, sponsor budget constraints, non-negotiable terms, the complexity of study requirements, internal review processes, legal review turnaround times, and the level of alignment between both parties.

If the sponsor is responsive and amenable to our site fees and other non-negotiables, this can significantly expedite the process. Additionally, CTP is working toward implementing standardized sponsor-specific rate cards and contract language to streamline and further accelerate budget and contract negotiations.

We maintain an internal quality monitoring program that reviews active clinical trial protocols and oversees compassionate use studies to ensure compliance and best practices.

Yes. The KPNC Clinical Trials Program utilizes the WCG IRB to ensure ethical oversight and regulatory compliance for all studies conducted. KPNC IRB handles submissions for minimal risk studies (including those involving vulnerable populations) while WCG IRB is used for clinical trials involving more than minimal risk. These IRBs play a critical role in maintaining the integrity and safety of clinical research conducted through the program.

Principal investigators and staff receive comprehensive training designed to ensure ethical, compliant, and high-quality research. This includes core certifications such as Human Subjects Research (HSR), Good Clinical Practice (GCP), and Responsible Conduct of Research (RCR). General trainings cover topics like informed consent procedures, HIPAA compliance, and standard operating procedures. Additionally, protocol-specific training includes site initiation visits (SIV), protocol amendment updates, electronic data capture systems, Salesforce & SMA training, and device handling. These educational pathways are supported by The Academy of Clinical Trialists (ACT) to build expertise among TPMG physicians and research staff.

The KPNC CTP supports source documentation and study data management through two integrated platforms: Florence HealthCare, which serves as the regulatory binder and subject binder system, and Verily, used as the Clinical Trial Management System (CTMS). Florence enables secure, remote access to study files, electronic signatures compliant with 21 CFR Part 11, HIPAA-compliant workflows, and centralized document control with real-time monitoring and audit trails. Verily enhances operational efficiency by digitizing study protocols into automated workflows, offering real-time performance and financial metrics, and facilitating collaboration between sites and sponsors. Together, these systems ensure accurate documentation, regulatory compliance, and streamlined data management throughout the lifecycle of a clinical trial.

The CTP offers study quality monitoring, a risk-based internal monitoring approach that focuses oversight on areas with the greatest potential impact to participant safety, data integrity, and compliance.

Yes. The Clinical Trials Program (CTP) oversees and coordinates all investigational drug and pharmacy services in partnership with our Regional Pharmacy team. We have a dedicated regional pharmacy lead who serves as our primary liaison to ensure alignment and support across study sites.

CTP and the Regional Pharmacy Lead ensure that all Investigational Products (IP) are:

• Stored, handled, and dispensed in accordance with sponsor requirements, FDA regulations, Good Clinical Practice (GCP), and Kaiser Permanente standard operating procedures.
• Fully documented with complete accountability, including temperature logs, chain of custody, and reconciliation.
• Monitored regularly for compliance, stability, and expiration dating.
• Supported with ongoing communication across study teams, providers, and pharmacy staff to ensure safe and compliant use in patient care.

We also coordinate pharmacy feasibility assessments, site training, new study startups, and ensure all necessary delegation, documentation, and workflows are in place before activation.

Yes. Our Clinical Trials Program (CTP) provides full coordination and oversight of specimen collection, processing, and shipping in accordance with study protocols, GCP, and FDA/ICH guidelines.

Our capabilities include:

• Coordinating phlebotomy, biopsy, and other protocol-specific specimen collection procedures.
• Ensuring proper labeling, documentation, and chain of custody.
• Processing specimens according to protocol requirements (e.g., centrifugation, aliquoting, freezing, room temperature storage).
• Preparing and packaging specimens using International Air Transport Association (IATA)-compliant shipping standards for biological materials.
• Managing courier scheduling and tracking to central or specialty labs.
• Maintaining specimen logs and reconciliation records for audit readiness.
• Training study staff on protocol-specific handling and shipping procedures.

CTP and labs work together to ensure specimens are collected, processed, and shipped accurately and on schedule, maintaining specimen integrity and regulatory compliance at all stages.

The KPNC CTP adheres to federal regulations and ICH Good Clinical Practice (GCP) guidelines. These typically require retention of essential documents (e.g., consent forms, source data, regulatory files) for at least 2 years after the last approval of a marketing application or as long as required by local regulations or sponsors.

If patient stipends are to be distributed by Kaiser Permanente, they will be processed using the Mural Link application (Mural Health for Sites & Sponsors – The Mural Link Platform).

Participants will be consented either in person using paper consent forms or Docusign.

Clinical trial protocols undergo a structured feasibility review process that includes:

• Patient population and eligibility assessment using EHR and clinical data
• Confirmation of PI and care team interest and capacity
• Pharmacy, laboratory, and procedural service availability
• Site resource and staffing assessment

We view clinical trials as an extension of enhanced clinical care. If the study addresses a meaningful clinical need, fills a gap in treatment options, or benefits a population with unmet needs, we prioritize participation when operationally feasible. This includes intentional consideration of how research can improve access and outcomes for underserved or high-need patient groups.

We provide sponsors with feasibility feedback and operational considerations prior to site selection.