Bio-Linked Participants

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Bio-Linked Participants

BioSubjects


Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research.


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Overview

Our facilities ask volunteer blood donors and the general public if they would like to participate in research studies. Persons that indicate availability are then targeted for specific health history screening and/or medical evaluations to identify disease states and targets that a researcher may need to accomplish a specific research objective. This data is used to create a biological profile for the individual. The individual is provided on-line access to their profile and can update and edit it independently. Our facilities provide a vast and diverse network of individuals that are willing participants in minimally invasive studies. Additionally, through routine mass screening and testing of plasma samples, our facilities have an inventory of plasma positive for specific disease targets that can be provided as de-identified/non-linked samples for research

Our facilities also have the ability to contact these willing participants both now and in the future. Therefore, using specific research objectives we can poll or interview participants to identify and select subjects that represent a specific demographic of the population and/or markers required to evaluate disease agents. Each questionnaire can be tailored to best identify the population of subjects needed.

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BASIC REQUIREMENTS


Study Phase
N/A Pre-Clinical Clinical Phase 1 Clinical Phase 2

Number Range of Subjects
N/A 1-25 25-100 100-499 500-999 1000-1499 1500-1999 2000-5000

Phlebotomy
N/A Sample Tubes Unit Collection

Donor Data
N/A Medical History Social History Family Medical History Family Social History Medication History

Specimen Type
N/A Body Fluids Blood Bone Marrow

Medical Characteristics
N/A Type 1 Diabetes Healthy Type 2 Diabetes Heart Disease Lung Disease Cancer Bleeding Disease Arthritis Vision Disease Autoimmune Central Nervous Digestive

Urinary Reproductive

Behavior Characteristics
N/A Depression Healthy ADHD ADD Schizophrenia Bipolar




DONOR SPECIFICATIONS


Gender
N/A Male Female Both

Age
N/A 18-40 50-65 Older than 65

Ethnicity
N/A African American Caucasian Native American Hispanic Asian Native Hawaiian or Pacific Islander

Blood Group / Type
N/A A+ A- B+ B- AB+ AB- O+ O- RBC Phenotype

Preparation
N/A Steroid Mobilization Fasting Mozobil Mobilzation GCSF Mobilization

Criteria
N/A 21 CFR 1271 21 CFR 600 FACT HRSA-OPTN AABB

Medications
N/A Have Not Taken Have Taken Cardiovascular Antiarrhythmic Penicillins Cephalosporins Sulfonamides Tetracyclines Antihypertensives Anticonvulsants Analgesics Sedatives Anticoagulants

GI Agents Hormones Immunologic Metabolic Psychotherapeutic Respiratory Contraceptives

Infectious Disease Test Positive
N/A HIV NAT HIV 1/2 HCV Antibody HCV NAT HBV Antibody HBV NAT WNV NAT Chagas Antibody Zika NAT CMV Antibody Syphilis Antibody

Abnormal Laboratory Test
N/A Total Cholesterol HDL LDL ALT AST PSA A1c T4 TSH Pap Smear

Cardiovascular Disease
N/A High Blood Pressure Congestive Heart Failure Coronary Artery Disease Angina Arrhythmia Stroke

Endocrine Disease
N/A Diabetes Type 2 Diabetes Type 1 Hypothyroidism Hyperthyroidism Hashimoto's Thyroiditis

Gynecological / Urological Disease
N/A Kidney Stones Chronic UTI Renal Insufficiency

Hematological Disease
N/A Sickle Cell Hemophilia Anemia TTP Lymphoma Leukemia

Oncological Disease
N/A Breast Prostate Cervical Liver Lung Melanoma

Pulmonary Disease
N/A COPD Asthma Cystic Fibrosis Emphysema Tuberculosis

Autoimmune Disease
N/A Rheumatoid Arthritis Addison's Chronic Thyroiditis Celiac Sjögren's Lupus Graves Scleroderma

Digestive Disease
N/A Crohn's Irritable Bowel GERD Ulcer Reflux Ulcerative Colitis

Neurological Disease
N/A Seizures Alzheimer's Multiple Sclerosis‎ Migraines

Ophthalmic Disease
N/A Cataracts Blindness Glaucoma Uveitis

Platelet Antibodies
N/A Anti-HPA-1 Anti-HPA-2 Anti-HPA-3 Anti-HPA-4 Anti-HPA-5 Anti-HPA-6 Anti-HPA-15

COLLECT:

Custom collections from a pool of thousands of healthy donors.

CHARACTERIZE:

Flowcytometry characterization of immune cells.

ISOLATE:

Research or GMP grade positive or negative cell selection procedures.

EXPAND:

Flask or automated expansion services.

FREEZE:

Controlled rate freezing using custom cryo-preservatives.

STORE:

Monitored LN2 vapor phase storage of products and samples.