Quality and compliance
One quality system, wherever the visit happens.
Community sites and in-home visits run under centralized SOPs, training, and documentation standards, with records that stand up to review.
Why it matters
Access without governance is risk. A network only helps a sponsor if every location, and every home visit, runs the same way.
Hawthorne was built as one operating model rather than a collection of sites. Centralized governance keeps quality, training, and reporting consistent across 9 community sites and 2,000+ GCP-trained nurses under one quality system. Local teams keep patients engaged. The result is protocol-compliant execution across geographies, with one point of accountability.
How quality is run
Six controls, applied the same way at every location.
Centralized governance
All sites and all home visits operate under one set of SOPs, one quality system, and centralized training. Feasibility, startup, and quality oversight are led centrally; local teams focus on patients, coordination, PI oversight, and study delivery.
Trained to the protocol
Investigators, coordinators, and nurses are trained in GCP/ICH, HIPAA, Hawthorne SOPs, and study-specific protocol and laboratory requirements before their first visit. Training completion and delegation are tracked and available for review.
Documentation and systems
Electronic source data is completed accurately and quality-reviewed at every location. For in-home visits, it is also shared securely with the study site within 24 to 48 hours. Training, delegation, and documentation records are maintained in 21 CFR Part 11-compliant systems.
Investigator oversight
Board-certified principal investigators with direct trial experience in their indication oversee study conduct at each site, with the same delegation and oversight standards across the network.
Monitoring
Monitoring remains CRO-led and risk-based. Our centralized structure gives monitors consistent documentation and one point of accountability across all locations. Hawthorne supplements sponsor and CRO monitoring with risk-based internal quality reviews and audits to assess study conduct, support consistency and compliance, and strengthen quality across the network.
Sample integrity
Local and central laboratory collection with on-site processing per the laboratory manual, and packaging and shipment under protocol, laboratory manual, and IATA requirements, including courier and dry ice coordination.
Sample integrity
Collected, processed, and shipped under the protocol and the laboratory manual.
What sponsors and CROs can review
Records available for PI and sponsor review.
- Training completion records for investigators, coordinators, and nurses, including GCP/ICH, HIPAA, and study-specific training
- Delegation logs and licensure for all staff working on your study
- Standard operating procedures relevant to the study, on request under NDA
- Electronic source documentation and quality review records
- Visit-window adherence and rescheduling records from centralized scheduling
- Sample chain-of-custody, processing, and shipment records
Privacy and data
Patient data handled according to HIPAA and the protocol.
All staff are trained in HIPAA. Study data is collected in electronic source systems, quality-reviewed, and transmitted securely to the study site. Records are maintained in 21 CFR Part 11-compliant systems with audit trails. Patient-facing materials and consent follow the IRB-approved protocol at every location.
Common questions
What quality and clinical operations teams ask.
Do you have one quality system across sites and home visits?
Yes. Community sites and in-home visits run under centralized SOPs, training program, and documentation standards. A visit conducted at a patient's home is held to the same standard as a visit at a site.
Who monitors the study?
Monitoring remains CRO-led and risk-based. Our role is to make monitoring efficient: consistent documentation, one project manager, and one point of accountability across locations.
How quickly is source documentation available?
Electronic source data for in-home visits is quality-reviewed and shared securely with the study site within 24 to 48 hours of the visit.
How are nurses qualified?
Nurses are licensed registered nurses in their practicing states, trained in GCP/ICH, HIPAA, Hawthorne SOPs, and the study protocol and laboratory manual. Primary and backup nurses are assigned by geography, and the same nurse is retained across visits where feasible.
What systems do you use for records?
Training completion, delegation, and documentation are maintained in 21 CFR Part 11-compliant systems and are available for PI and sponsor review.
Can we audit a site or the central quality function?
Yes. Sponsor and CRO audits are supported at any site and centrally. Contact studies@hawthornehealth.com to schedule one or to request the quality documentation package.
Ready for review
Request the quality documentation package.
SOPs on request under NDA, training and delegation records, and a walkthrough of the quality system with our operations leadership.