Research & Scientific Approach

In clinical studies, the critical decisions are made before the study even begins.

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Building Clinical Evidence for Decision-Making:

KCRI engages in research and scientific collaboration to strengthen how clinical evidence is designed, generated and interpreted.

This perspective allows us to approach clinical development as a structured process of evidence building aligned with regulatory and clinical decision-making.

Designing Studies Backwards from Evidence Requirements:

In many projects, study design begins with operational feasibility.
Our research background allows us to start from a different point:
→ what evidence will be required at the moment of regulatory or clinical decision-making.

This shifts how endpoints, populations and methodologies are defined from the outset.

Bridging the Gap Between Study Execution and Evidence Interpretation

A study can be executed correctly and still fail to deliver usable evidence.
We focus on identifying where study assumptions may not translate into interpretable results.

This reduces the risk of generating data that are technically correct but not decision-relevant.

Where Clinical Risk Actually Emerges

Clinical risk often emerges before the study begins – in endpoint definition, study assumptions and interpretation frameworks.

Our research-driven perspective helps identify these risks early, before they become embedded in study design.

Consistency of Evidence, Not Only Data Quality

High-quality data alone do not ensure meaningful conclusions.
What matters is consistency across sites, populations and time, and whether results support a coherent clinical narrative.

This is critical for regulatory review and decision-making.

From Execution to Interpretation

KCRI’s involvement in research and scientific collaboration strengthens not only how studies are conducted, but how their results are understood and used in decision-making.

Grant activities

Besides providing quality research services for our industry clients, we are also committed to being an active participant in, and contributor to advancing clinical science and innovative product and process development.

To that end, KCRI has an ongoing in-house initiative to seek research and development funding opportunities from Polish, European, and other international sources and match them with our interest and expertise, as well as with those of our Partners’. We apply and participate as the main grant recipient or as a partner in multi-institution consortia or as a subcontractor.

We are an active participant in projects under Polish, European, and international Programmes.

Grants 2019-2021

Completed

Project No. PMT/0556/4N/2019

Project No. PMT/0556/4N/2019 under the Smart Growth Operational Program 2014-2020, Priority axis III “Support for innovation in enterprises”, Measure 3.3 “ Support for promotion and internationalization of innovative enterprises”, Sub-measure 3.3.1 “Polish tech Bridge”. Co-financing of the project from the EU: 200 000,00 PLN

Co-financing of the project from the EU: 200 000,00 PLN

The company participated in the implementation of the project to expand into the Israeli market, using for these purposes consultation of local experts, information and promotion activities and participation in industry conferences, trade and exhibition events.

Events 12.12.2021

EuroPCR 2018 in Paris

KCRI in collaboration with Klaster LifeScience Kraków on 22-25 May 2018 took part in EuroPCR 2018 in Paris as the part of “PROmocja potencjału gospodarczego BIORegionu MAŁOPOLSKA na arenie międzynarodowej (ProBio Małopolska)” project implementation.

KCRI in collaboration with Klaster LifeScience Kraków on 6-8 November 2017 took part in BioEurope 2017 in Berlin as the part of “PROmocja potencjału gospodarczego BIORegionu MAŁOPOLSKA na arenie międzynarodowej (ProBio Małopolska)” project implementation.

BIO-Europe is an annual event being the largest biotechnology partnering conference held in Europe. Over 3,800 global decision makers from biotechnology, pharma and finance annually attend BIO-Europe to identify new business opportunities and develop strategic relationships. Business development executives and dealmakers consider BIO-Europe a must-attend event and an effective business strategy enabling them to meet and present to numerous potential partners. BIO-Europe features the industry’s most advanced web-based partnering system enabling delegates from all parts of the biotechnology value chain to quickly identify, engage and enter into strategic relationships that drive their business successfully forward.

Events 12.12.2021

Smart Growth Operational Program 2014-2020, Priority axis III “Support for innovation in enterprises”

Grants 2015-2018

Completed

Integrated device system for transcatheter closure of paraVAlvular LEaks (VALE)”

Project “Integrated device system for transcatheter closure of paraVAlvular LEaks (VALE)” (2015-2018)

Grants 2007-2013

Completed

Project “WROVASC – Integrated Cardiovascular Center

See more grants

Investigator sponsored and initiated research

Are you a physician and investigator?
Do you have an interesting clinical research idea?
Do you plan a research grant with clinical study?

KCRI helps to translate your idea into a trial project assuring proper quality and compliance with ICH-GCP guidelines and regulatory standards.Our company was started by physicians and researchers – no one will understand your problems and needs better.

Treatment strategy comparisons, interesting concepts from individual investigators, niche applications, and unmet clinical needs require professional support and research infrastructure. One of KCRI’s goals is to enable and support these activities.

MDR Complience & quality

KCRI has the working knowledge of the Medical Devices Regulation

See MDR compliance & quality