Clinical data &
related information
The success of the research very much depends on the time it takes to collect high quality biospecimens and related clinical data. BioPartners maintains high standards of collection and provision of the relevant clinical data.
Clinical data are provided de-identified and are completely anonymous according to the ethical requirements of Good Clinical Practice, GDPR and BioPartners’ SOPs, compliance with that is controlled by certified personnel of the company.
All provided clinical information is monitored for accuracy and completeness, as well as conformity and controversies in the diagnosis, staging and follow-up evaluation.
To effectively achieve all the research goals, on Client’s request, we can develop a special Case Report Form (CRF), form of clinical data manifest or any requested report form in order to provide our Clients with maximum useful clinical and sample processing information in the most convenient form (please see manifests templates examples below).
The certified pathologist provides detailed pathology diagnosis review to every tissue type offered by BioPartners.
BioPartners, from their own sources, can provide a quite extensive set of de-identified data selected according to the Client’s request and the data for a statistical analysis. We also have an extensive experience of participating in the projects related to collection of clinical data (without biospecimens). For example, for such types of study we provided de-identified copies of CT images and related clinical data from the patient with particular health condition.
Clinical data are entered into the BioPartners’ own protected electronic database. We also can work with other study products such as Medrio, Xolomon, etc.
In case the case/sample qualification or quality confirmation requirements are beyond the diagnostic routine at our clinical sites, we can perform any additional examinations or tests available in our partner laboratories in Ukraine, Europe, or USA.
CVD STUDY
BioPartners have successfully completed nine projects with collection of blood samples from patients (over 5 000 enrolled subjects in total) with cardio-vascular disease risks or already diagnosed condition(s). We have access to almost unlimited number of patients with angina and myocardial infarction (commonly known as a heart attack), stroke, heart failure, hypertensive heart disease, pulmonary hypertension, rheumatic heart disease, cardiomyopathy, abnormal heart rhythms, congenital heart disease, valvular heart disease, carditis, aortic aneurysms, peripheral artery disease, thromboembolic disease, and venous thrombosis, etc. Please see an example (template) of the manifest with clinical data for CVD project.
INFECTIOUS DISEASE STUDY
From our numerous collection sites, we have access to patients with infectious diseases affecting respiratory tract or urogenital organs, skin, or systemic diseases. Patients can be enrolled and biospecimens can be collected once or several times at any stage of the disease development (at the first disease manifestation before treatment, during therapy, at the convalescent period, or after the onset of the infection-related complications). Please see an example (template) of the manifest with clinical data for infectious disease project.
ONCOLOGY STUDY
We are experts in conducting oncology-related projects and can provide our Clients with a wide range of biospecimen types (including matched samples) collected at any required stage of disease management (diagnosis, pre- and post-surgery, during neo- and adjuvant treatment or remission period) from patients with primary or metastatic tumor of different location: breast, head and neck, stomach, esophagus, liver, pancreas, colon, uterus, ovaries, skin, etc.
Information provided along with the samples will include: sample ID, information on its collection, processing and storage, demographic data (patient’s age, gender), diagnostic data (instrumental and laboratory methods of examination), diagnosis based on histology study of the biopsy, post-operative pathology report (tumor type, grade, TNM, stage, tumor size, number of examined and metastatic lymph nodes, date and name of the surgical operation), IHC data, tumor marker status (e.g. PSA, CA-125, CA 19-9, CEA, CYFRA 21-1, etc.), location of metastases (disease spread confirmed by relevant clinical examination data and pathology report), co-morbidities, cancer anamnesis and family cancer history, treatment history. Please see an example (template) of the manifest with clinical data for oncology project.
HEALTHY DONORS (CONTROLS) COLLECTION
Clinical research and medical discovery depend on volunteers who participate in clinical research studies. Health information of “normal controls” can be used as a comparison (for example, in the studies where researchers need to compare healthy volunteers with people who have a specific disease or condition).
Healthy volunteers have always played a vital role in medical research. When developing a new technique such as a blood test or imaging device, we need clinical research volunteers to help scientists to define the limits of “normal.”
Normal donors are recruited separately according to the requirements indicated by the Client or they are enrolled specially to serve as controls for patient groups. They can be matched to patients on such characteristics as age, gender, smoking status, etc. In this case, they are then given the same test; their samples are collected and processed in the same way as the patient group does. Investigators learn about the disease process by comparing the patient group to the clinical research volunteers.
In a clinical study, a person who does not have the disorder or disease being studied. If not indicated otherwise in the Client’s request, the subjects are selected if they meet the following criteria:
- No cancer in anamnesis
- No drug addiction in anamnesis
- No auto-immune disease in anamnesis
- No signs of acute disease
- No HIV, HBV, HCV or syphilis history
Please see an example (template) of the manifest with clinical data for healthy controls collection.
WE ARE THE TRUSTED EXPERTS
WE KEEP THINGS running smoothly
To our Clients we offer a vast variety of human biospecimens from our stock available for order right away. In addition, biospecimens can be collected prospectively in timely manner and according to the unique needs and goals of your project.
