How Sanguine Biosciences
Meets the Needs for HBV Research
Sanguine Biosciences is customizable to your research. We have successfully executed many HBV studies with diverse inclusion/exclusion criteria, as well as biospecimen and study data collection needs as detailed in Table 1 and Figure 1.
TABLE 1. Typical inclusion and exclusion criteria as well as biospecimen and study data collection supported for HBV studies. All participants enrolled in a research study are medical record-verified for their diagnosis and medical history before in-home sample and data collection. Other study data requirements, including specialized sample processing can be met as requested.
INCLUSION CRITERIA
Chronic HBV infection
Positive for HBsAg
Previously Diagnosed with HBV
EXCLUSION CRITERIA
+/- immunosuppressant use(e.g., Prednisone,Tacrolimus, Cyclosporine)
+/- diagnosis of HIV, HCV, HAV or other coinfections.
BIOSPECIMEN COLLECTION
Whole blood
Serum
PBMCs
STUDY DATA COLLECTION
HBV genotype
HLA typing
Viral Loads
Medical history records
Patient Reported Outcomes (PRO)
FIGURE 1. Examples of completed or ongoing HBV studies we have participated in.
Why Sanguine
A custom-tailored approach means an enhanced ability to recruit participants and procure biospecimens prospectively. You’ll get more accurate data points per sample, increased study design flexibility, and an expedited time to completion.
Longitudinal and event-based biospecimen and data collection
Same-day sample collection and delivery
Nationwide patient member community to meet complex inclusion/exclusion criteria
Medical record-verified eligibility and pre-screening
Access to electronic medical records, health histories, patient-reported datasets
Long-term follow-up with study participants
Compliance & Quality Assured
Sanguine utilizes two internationally-recognized IRBs (Advarra and WCG IRB) for review and approval of all study protocols, specific study documentation, and study participant facing information. Both Advarra and WCG IRB are organized and operates in compliance with: FDA, OHRP, and International Conference on Harmonization (ICH).
Sanguine operates under an electronic informed consent process which executes 21 CFR part 11 compliant e-signatures, and Sanguine systems interacting with study participant information are HIPAA-compliant.
We Specialize in These Conditions
Behind our therapeutic experience are patient member communities made up of more than 30,000 total members ready to advance science and medicine for the conditions they live with.
