Accelerating Clinical Development Programs and Reducing Costs
Sanguine’s patient-led approach and operational experience has allowed us to become industry leaders in the decentralized clinical study approach. Our leading advantage – a mobile direct-to-patient approach and a growing >50,000 patient database – brings research participation into the patient’s home with a primary focus on establishing trusting, long-term relationships with study participants. In our efforts to continuously innovate and improve our approach to clinical research, we have introduced a new “Condition Access Model” to our academic and pharmaceutical research partners to reduce timelines and save costs when running multiple clinical studies in the same patient populations.
This new model will allow us to expand the options we give our research partners when initiating studies with us. Previously, each study with us was considered an independent entity, with separate contract negotiations, protocol reviews, IRB and start-up fees. Although our traditional model works for many our partners, some are looking for repeat access to certain patient populations over many consecutive studies, with reduced study timelines being critically important to the progress of their research. By establishing a blanket contract that covers several studies within the same populations, researchers can quickly initiate requests to mobilize our team to collect necessary samples based on clinical program needs that can evolve over time.
Our conditional access model allows for:
Accelerated clinical timelines & reduced overall costs
We are giving increased flexibility and extensive customization to researchers to rapidly enroll in each study, while also eliminating the red tape and typical study start-up procedures that increase timelines and costs. Researchers submit an umbrella protocol that can encompass several studies and can be modified over the course of the contract. Through this agreement, we can review each new study within 3 business days and complete sample requests within 3-4 weeks, allowing for rapid study mobilization and decreased study timelines.
With a mobile nationwide workforce, our virtual recruitment and in-home biospecimen and data collection capabilities translate to minimal disruption to patients’ lives, consistently high study retention rates and long-term commitment to study participation. As such, we are uniquely powered to conduct studies that rely on longitudinal sampling with complex criteria or event-based triggers in hard-to-reach populations. We can easily request additional samples from prior donors in our studies using a Sanguine-assigned and employee deidentified classification system, making it easy for the same participants to re-enroll in future studies. Our sample collection workflow ensures that even the most time-sensitive samples are processed and shipped promptly to ensure viability. We can acquire whole blood, buccal swabs, hair, skin taping, nails, NP swabs, urine, stool, saliva, semen and sputum samples. We can also process PBMC, buffy coat and plasma/serum samples at our partner labs according to researcher specified needs. Access to previous medical history, the design of electronic questionnaires or the incorporation of patient-reported outcome technologies can be easily integrated based on study needs.
This new contract model is a highly customizable partnership with us specifically aimed to accelerate clinical development programs. The contract is built based on annual access and is tailored to the specifics of the clinical program, with access to just one or several related patient populations. Study designs, sample types or frequencies of collection can also easily be changed without requiring contract negotiations or a change order to the agreement. This approach also allows for better cross-collaboration across multiple research teams working together on related projects within the same populations.
At Sanguine, our mission is to accelerate clinical research to help drive scientific discoveries and improve patient lives. Our new Condition Access Model is meant to address key pain points that researchers experience during clinical development to shorten study timelines and reduce start-up costs, while providing a customizable, flexible approach to study recruitment and sample collection. We bridge researchers with patients, giving you access to a powerful platform for advancing biomedical research and having a tangible effect on patients’ lives. We are the missing link – facilitating patient recruitment and at-home data and sample collection through an innovative mobile research approach.