Biospecimen Collections and Products

Fidelis offers prospective collections and banked disease state and control biospecimens for research purposes

Fidelis Research is specialised in the procurement of high-quality human biospecimens and value-adding ancillary services. We support researchers globally by collecting and processing a broad range of disease-state and control samples accompanied by comprehensive annotated data.

Our extensive network of sites allows us to enroll a large number of diseased and healthy patients under custom inclusion criteria with both commonly used and difficult to find human tissue and biofluid specimens for translational research.

Fidelis works with standard and customer-specified collection and processing protocols, using dedicated facilities and central laboratories in each country of collection to guarantee consistency in procedures and quality across samples. We have built a reputation of a professional partner ensuring access to high volume of research specimens with consistent information, quality and de-identified patient disease information.

Ready-to-ship banked samples

Our inventory of samples consists of high quality, annotated samples from various disease states and formats: plasma, serum, PBMCs, BMMCs, FFPEs, frozen tissue, dissociated cells and others. These samples are available for immediate shipment for an even faster way to get your research up to speed.

Our partners use the specimens we provide for:

• identifying the causes and mechanism of action of diseases

• identification of disease-relevant genes or mutations

• development of new drug molecules

• biomarker discovery in drug development

• development of new diagnostics methods and devices

Fresh diseased tissue and/or normal adjacent tissue (NAT)
Frozen diseased and/or NAT tissue
Cryopreserved diseased and/or NAT tissue
Dissociated tumor cells (DTCs)
FFPE diseased and/or NAT blocks (incl. characterization / sequencing data)
FFPE cell blocks
FFPE/TMA tissue slides
H&E whole slide scan
OCT blocks
Tissue Microarrays (TMA)

Blood

Whole blood
Plasma
Serum
Peripheral blood mononuclear cells (PBMCs)
Buffy Coat

Bone marrow

Bone marrow aspirate
Bone Marrow Mononuclear Cells (BMMCs)
Human Bone Marrow CD34+ Stem Cells
Trephine biopsies

Cord blood

Whole cord blood
Cord blood MNC
Human Cord Blood CD34+ Stem Cells

Other

Pleural effusion - including fresh, frozen or cryopreserved single cell suspension
Ascites - including fresh, frozen or cryopreserved single cell suspension
Synovial fluid
Cerebrospinal fluid (CSF)
Urine
Saliva
Sputum
Oral Swabs
Stool

Matched sets of samples from the same donor
Longitudinal collections from the same donor
Custom products

Fidelis will work with a vast network of sites and physicians to ensure that the patients donating samples match your exact inclusion and exclusion criteria:

Indication
Stage of disease
Treatment status / history
Viral status
Demographic characteristics (Age/Sex/Ethnicity)
Others

Our lab team can provide a ready protocol or consult, validate and implement custom options for:

Tissue processing procedures
Cell isolation and processing
Multiple cell types from a single collection
Custom vialing and cell counts

Our team will prepare labeling, collection kits, shipping kits and options

Custom labeling using client-specific sequence IDs
Media and anticogulants
Cryopreservatives
Shipping containers and conditions

Our experience will help you get biospecimens delivered directly from the sourcing site to your labs or stored at specialised facilities until shipment. We offer multiple delivery options, incl. cryogenic, frozen, cooled and ambient temperature sensitive shipments. Fidelis works with all major carriers to offer the best shipping solution based on the sample types and requirements.

We work with all main couriers to provide the fastest options for receipt of fresh samples in Europe, the US and globally.

Within Europe, delivery can be same-day (evening) or next-day delivery, ensuring the integrity and viability of various sample types.

Expedited delivery to the Untied Stages may take as little as 24 hours (with specialised services) and on average 48-96 hours.

Samples can be shipped at 2-8 C (chilled), as well as ambient temeprature (15-25 C) depending on project requirements.

Frozen samples can be shipped in batches on dry ice or in cryogenic shippers (on Liquid Nitrogen Vapor Phase). Fidelis uses couriers specialised in temperature controlled shipments to ensure dry ice or LN2 is topped up for as long as it may take for the shipments to reach any point in the world.

Fidelis Research maintains the principles of autonomy, privacy safety and informed consent.

We promote voluntary donation of human biospecimens and clinical information for medical research.

We ensure that all our activities, as well as those of our collection sites, are conducted in accordance with applicable laws, regulations and ordinances. All informed consent form templates are subject to review and approval by Ethics Committees.

Fidelis Research values the protection of personal and confidential medical information. We require identifying information about the subjects to be removed at the source of collection; this information is not transferred to our clients.

The US Food and Drug Administration has provided numerous guidances to the biopharmaceutical industry on the use of human tissues as well as the import of tissues in the United States. Below is a sample of relevant statements:

Draft Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products
Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity
Compliance Guide
FDA Oversight of the tissue bank industry
FDA Guidance on import/export of human tissues to US

Fidelis can offer support along all steps necessary under the new IVD regulations to bring into service in vitro diagnostic medical devices on the European and US markets.