Patients are found via several unique approaches depending on the therapeutic area and patient population. The primary methods used for patient recruitment includes partnering with non-profit organizations and online communities, social media outreach, and traditional online advertising. Currently, Sanguine has over 70,000 patients within our community.
Yes, patients are always compensated for their participation. Compensation amounts vary depending on the sample(s) being collected and the assumed length of the phlebotomist visit.
Sanguine exclusively recruits patients that reside within the United States, however, we have partnered within organizations all over the world to provide them with prospectively-collected biospecimens.
Sanguine tiers their pricing based on the size of the patient population and the specificity of the desired inclusion/exclusion criteria. For example, a patient with rheumatoid arthritis (RA) will be easier to find than that of a patient with a rare genetic disease, resulting in a lower patient acquisition cost for patients with RA. Sample type does not have a significant impact on cost. The collection of whole blood, hair, and urine from a patient would be roughly the same cost as the collection of just whole blood from the same patient.
Sanguine patients are considered healthy if they are in a state of general wellness, have no underlying or chronic conditions, and are not currently suffering from an infectious disease. See the benefits of healthy patients here.
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.
All clients with an active Sanguine study will be given access to a SmartSheet portal which is updated in real time regarding patient recruitment, biospecimen collection, and sample delivery. Typically, clients will know about a week in advance of when to expect a sample delivery.
Sanguine can collect any biospecimen obtained in a non-invasive manner. Generally, if the sample requires a hospital setting to be collected, Sanguine cannot collect the sample. An exception is white blood cells collected by apheresis, which is performed at our apheresis donor site in Los Angeles or qualified partner sites nationwide.
Study Design & Sample Logistics
Sanguine can retrieve any data point from a medical record once it is specifically requested by the researcher, including patient scans and imaging reports, lab results, and treatment history. However, Sanguine cannot guarantee which information will be in the patient's medical records at the time of biospecimen collection.
After a study has been initiated, clients can typically expect to receive their first sample no sooner than 30 days after the study kick-off meeting.
Medical records can take an average of 4-6 weeks to retrieve and pull the necessary information.
Yes, Sanguine partners with a CLIA certified facility that can perform over 70 different diagnostic tests. These tests include, but are not limited to, infectious disease panels, cytokine quantification, and HLA typing.
Absolutely! Sanguine has a large healthy patient community that can be recruited to match the demographics of the experimental group. For example, we can acquire an experimental patient who is 45 years old with Celiac's disease, then recruit a confirmed healthy patient of the same general demographics and within +1/-1 years age of the experimental patient.
Sanguine phlebotomists will bring a small centrifuge with them to the patient's home. Once the whole blood is collected, the blood is then centrifuged to achieve gradient separation, followed by the collection and subsequent aliquoting of either serum or plasma layers. Plasma samples are isolated immediately upon blood collection whereas whole blood destined for serum isolation is allowed to clot at room temperature for 30 - 45 minutes prior to centrifugation. See our in-home serum and plasma processing procedures here.
Sanguine performs high-quality PBMC or TBNK cell isolations at our San Diego, CA-based laboratory. After whole blood is collected from the patient, the sample is then shipped to our lab for processing. PBMCs are isolated by a density gradient standard operating procedure (SOP) specific to whether the source is whole blood or apheresis, achieving ≥95% cell viability per aliquot. See our immune cell isolation document for more information.
Samples can be shipped either ambient, on ice packs, or on dry ice, depending on your preference and sample stability. If sample storage is involved, we can also arrange sample shipments on both a rolling basis or one-time batch shipment. Lastly, samples can be collected and delivered to your lab within 4 hours the same day.
Yes, Sanguine adheres by the rules established by governing bodies that dictate how much blood a patient can provide within a 6-week period. For the most part, healthy patients can typically provide up to 180mL of whole blood within a 6 week period, whereas donors with a diagnosed illness can typically provide 60mL - 100mL of whole blood within a 6-week period.
Yes, Sanguine has over 8 different buffers to choose from as well as over 20 different tube types and sizes, including both RNApax and DNApax tubes. Should you require a tube that Sanguine does not currently have, we can prospectively source the materials necessary for your project.
Typically, 1mL of whole blood will produce 1 million PBMCs. A 100mL sample of whole blood collected from a patient will typically yield 100 million PBMCs.
Yes, Sanguine can collect skin samples, however, skin punches are considered too invasive and cannot be obtained. Instead, Sanguine relies on a Skin Taping protocol to obtain various surface layer elements, such as skin cells, proteins, and kinases. To learn more about Sanguine's skin taping protocol, click here.
All client's with an active Sanguine study will be given access to a SmartSheet portal which is updated in real time regarding patient recruitment, biospecimen collection, and sample delivery. Typically, clients will know about a week in advance of when to expect a sample delivery.
Once the study is initiated, you will be assigned a project manager who will serve as your main point of contact throughout the study. Sanguine project managers can either answer your questions directly, or find the correct Sanguine personnel to assist you. Project managers usually respond to client requests within the same day.
Yes, Sanguine routinely partners with non-profit organizations across a wide variety of therapeutic areas. Sanguine can typically partner with any organization or contract research organization if it furthers the completion of the study.
If a sample arrives in an unusable condition, please let your Sanguine-assigned project manager know and we will work to immediately rectify the situation. While Sanguine cannot be held accountable for mistakes made during sample shipment, samples that have been negatively altered due to Sanguine collection or lab processes will be immediately replaced free of charge.
Sanguine will assign you an Account Executive to walk you through the study design process. Once finished, Sanguine's feasibility team will review the design to ensure that all aspects are within Sanguine's capabilities. If not, Sanguine will let the Account Executive know to contact you for a revision of the study prior to re-submission.