FAQ

frequently asked
questions

If you have any questions, you can familiarize yourself with frequently asked questions.
If you did not find what you were looking for, contact us.

Quality Management System

Does your company hold any Quality Management System?

Our company developed strict Quality Management System which is followed at every step of the project’s implementation.

Does your company have a quality manual?

Yes. We have developed SOP STANDARD OPERATING PROCEDURE (SOP) 100

Are QA and QC responsibilities defined ?

Yes

Do QA and QC approve all the analytical methods done in your company?

Yes

Do you set up corrective or curative actions to improve your process (in cases of non-conformities or complaints)?

Yes. It is done according STANDARD OPERATING PROCEDURE (SOP) 105

Are there any procedures for supplier selection, qualification and evaluation?

Yes, we are working with two exclusive subcontractors which were selected, qualified and evaluated according to all applicable internal procedures

Have you ever been audited by your clients?

Yes, we had and have successfully passed two audits. One audit was performed by one of world's top pharmaceutical company, and another one by National Cancer Institute of US.

Do you work with subcontractors for the service you provide ? If yes, how often does your company conduct audits of them?

Yes, we have two exclusive subcontractors located in Kyiv Ukraine. We perform annual audits.

Ethics

Are the samples de-identified?

Yes

Do your employees receive training regarding ethical practices?

Yes

Does your company have procedures to respond to ethics concerns?

Yes

Do patients sign an Informed Consent Form?

Yes, all our donors sign GDPR-complaint ICF before any type of collection

Are the donors aware of their samples purpose?

Yes, all our donors are aware of their samples purpose. The samples purpose is described in Patient Information Sheet and ICF which each donor sign before any type of collection.

Is there an Ethics Comitee approval (IEC/IRB) before any research project?

Yes, all research projects are performed only after obtaining Ethical Committees approvals.

Do they have the right of withdrawal if they want to?

Yes, it is described in paragraph 7.of Patient Information Sheet PARTICIPATION AND WITHDRAWAL FROM THE RESEARCH "Your participation in the Research is completely voluntary. If you decide to withdraw your consent to participate in this study, you can do it at any time. You do not have to explain why you withdraw your consent to participate in this study. If you change your mind and decide to withdraw your consent to participate in this study, inform your study doctor in written form. If you withdraw your consent, study doctor will stop collecting personal data, but already collected from you bio-specimens and data will be further stored and used in order to guarantee the validity of the study and to comply with regulatory requirements".

Informatics and Data Management

Is there an independant informatics unit to manage the data? If yes, how many people work in this unit?

Yes, 3 database managers are working in such unit

What kind of data are associated to your samples?

De-identified demographics and clinical data

Do you have any database to manage all these data?

Yes, internally developed database

Are there regular back-ups?

Yes

Who can access the data? Who can modify them?

Only authorized personnel has access to the database. The database is protected with individual passwords.

Are your employees trained on personal data management in biobanks, in the context of General Data Protection Regulation?

Yes

Are there any SOPs regarding computerized systems management?

Yes. We have developed SOP STANDARD OPERATING PROCEDURE (SOP) 113 BioPartners DataBase control system. DataBase security.

Samples Management

Are there independant areas for receipt and storage of your samples? Are the samples quality checked before being stored?

Yes, the samples are stored at the sites and then are being transferred to the main lab for further storage. Yes, the samples are checked before being stored.

Are temperature and relative humidity monitored and documented?

Yes, it is being done by our exclusive subcontractor and/or laboratories and/or Biobanks.

Do you regularly maintain your equipments (such as freezers, spinners, automata, etc.)? If yes, how often do you control them?

Yes, it is being done by our exclusive subcontractor and/or laboratories and/or Biobanks.

How do you track your samples?

According to our STANDARD OPERATING PROCEDURE (SOP) 106 Labelling and Tracking Biospecimen

Do you have any documented procedures regarding all the steps of your samples management process (storage, shipment, packaging, etc.)?

Yes, shipment and packaging are done according to our STANDARD OPERATING PROCEDURE (SOP) 107 Biopecimen Packaging and Shipping. Storage of different types of biospecimen is indicated in corresponding SOPs.

Do you sign a Material Transfer Agreement with your clients?

Yes

Do you work with outside service providers for international shipment (Fedex, World Courrier, etc.)? Which ones?

Yes, we mainly work with World Courier and DHL

Do you give a quotation to your clients summarizing the final price (including shipment, packaging, etc.)? How long is the delay to obtain this quotation?

Yes, for the majority of the requests we provide quotes within 2-3 days. It can take up to 5 days or longer for more complicated requests.

What is the delivery delay, after Purchase Order receipt?

The delivery date depends on the type of collection. For retrospective collection it takes about 7 days for the delivery after receiving the PO, and for prospective collection - time frame for the delivery is indicated in the PO

At which temperature do you store your samples?

Depending on biosample type, samples are stored at LN and its vapour phase, at -70°C or lower temperature, at -20°C, at +4°, or at room temperature.

How do you store them?

Liquid nitrogen tanks, freezers, others

Does your company make prospective collections?

Yes

Does your company follow regulations regarding Dangerous Goods Shipment?

Yes

frequently asked
questions

Quality Management System

Ethics

Informatics and Data Management

Samples Management

Send a Request
for service

Call Back