BioTheme collects biological raw materials consisting of human serum, plasma, urine, fresh tissue and tissue including paraffin embedded blocks with corresponding pathology reports. BioTheme obtains its biological raw materials through our managed collection sites. Our Company prospectively collects samples from various disease states and normal patient populations, and obtains data on every biological sample.

Cancer Research

BioTheme Research has established a network of community Oncology practices, Cancer Hospitals and associated Cancer Treatment Centers that collect biospecimens on a per protocol basis. All protocols are IRB approved and patients sign informed consents. Blood can be drawn in matrix of choice. Additional processing per protocol can be accomplished. Pre-operative or post-operative (pre-treatment) draws can be arranged. Serial draws throughout the course of treatment can also be provided. Complete patient history including treatment and outcomes can be furnished.
Additional information collected in prospective collections may include: risk category, symptoms, medications, concomitant conditions, clinical laboratory data, instrumentation and reagents, date and time of phlebotomy, surgical history, as well as other desired patient characteristics.

• Biological samples are drawn by clinicians and received and processed by BioTheme
• Samples may be collected as de-identified diagnostic remainders exempt from Title 46, Title 21 and HIPAA IRB/Consent requirements, collected under an IRB approved protocol or collected as consented donor samples from FDA licensed/registered facility following GMP’s.
• All samples are stored according to the protocol requirements
• Biological samples are accompanied by a Case Report Form (CRF) that includes a donor’s demographic and case history information

The biological raw materials obtained by BioTheme are used in oncology, infectious disease, genomics/proteonomics, research applications and in the testing and development of IVD test kits or quality control materials.

Clinical Research Services

The clinical research services offered by BioTheme include a full suite of clinical trial management services from initial study design to final regulatory submissions. Through its network of principal investigators:

BioTheme offers a complete suite of clinical trial management services, including:

• Introducing and explaining specific research projects to physicians and facilities
• The development of HIPAA-compliant informed consents, collection protocols and Case Report Forms (CRF).
• Institutional Review Board (IRB) submissions
• Site selection, initiation and monitoring
• On-site sample management and logistical support
• Short and long-term storage of samples in the our bio-repository
• Collation of specimens and data reviewed for accuracy and completion