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Non-interventional studies (NIS) have proven to be particularly helpful in the advanced market cycle of pharmaceutical products in order to confirm findings from clinical studies in the context of routine care and to provide additional benefits such as tolerance and / or quality of life statistics.


Non-interventional studies are studies in which drugs are prescribed in the usual manner in accordance with the terms of the approval. NIS involve database research or the preparation of records where all events of interest have already occurred (this can include case-control, cross-sectional, cohort, or other study designs with secondary use of data).


Non-interventional studies also include studies that involve primary data collection (e.g. prospective observational studies and registries in which the data collected come from routine clinical care), provided the above conditions are met. These studies may include interviews, questionnaires, blood samples, and patient follow-up as part of normal clinical practice.


NIS are particularly useful for highlighting the effectiveness, efficiency and safety of a drug in real-life conditions. In addition, non-interventional studies are not regulated by the Clinical Trials Directive (2001/20/EC) or the Clinical Trials Regulation (EU No 536/2014), which means that the GCP does not apply to them. Regulation of NIS occurs at state level and / or through the application of guidelines.

As a CRO, we support our customers by accompanying them from study planning to study implementation and administration to graduation:


Extract from our services in gynecological oncology


  • Study design (observation plan, eCRF, questionnaires, surveys)

  • Definition of centers for recruitment and management

  • Medical and scientific advice

  • Comprehensive study management

  • Takeover of the official submissions and approval procedures

  • IT infrastructure (electronic data acquisition, database services)

  • Data collection and management

  • Planning of statistical analyses and statistical evaluation

  • Final reports, publications, medical writing

  • AE / SAE / ADR / SADR management


The term "prospective" refers to an event that is likely or expected to occur in the future. Prospective studies are observational studies in which a group of people (cohort) is observed over a period of time to determine whether current events are related to the development of a future outcome.

In this type of study, outcomes such as the development of a disease are examined during the study period and related to other factors, such as assumed risk or benefit factors. The information must be generated during the course of the prospective study, and is not available before the start of the study.


Retrospective studies are observational studies that analyze data and information about events that have occurred in the past. In the case of a retrospective study, the results of the reference studies have already occurred before a retrospective study is initiated.

This allows retrospective studies to look back in time to determine whether past events are related to current results.


Our partnership with the BNGO enables us to look back at the past and to look into the future, in order to combine and analyze all the data held by the members that are necessary for the implementation of target-specific projects.


Cross-sectional studies are observational studies in which a group of individuals of different types is assembled into a large sample and examined at a single point in time. Thus, cross-sectional studies could be defined as a snapshot of a specific group of people at a specific point in time, in contrast to longitudinal studies, which are carried out over a specific period of time.

This type of study belongs to the field of descriptive research, meaning the aim is not to explain cause-and-effect relationships between the various variables, but rather to describe predominant characteristics in a particular population.


Cross-sectional studies are often used to draw conclusions about possible relationships or to collect preliminary data to support further research and experiments.


This type of study examines participants, processes, or systems over time, collecting data at multiple intervals. The two main types are prospective studies and retrospective studies.

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An increasingly dynamic scenario in the field of clinical research requires innovative methods for the collection and analysis of real-world data (RWD).

​In the context of healthcare, real-world data (RWD) refers to patient health data collected as part of routine treatment as opposed to data generated by conventional clinical studies in specialized research settings.


Such RWD mainly include data that are recorded by members of the health system (e.g. in general practitioners' practices, specialist medical practices or hospitals, professional associations), in registers and documentation systems. Furthermore, satisfaction surveys can also be documented directly by the patient.


Thus, RWD can cover a variety of aspects, such as basic demographic data (e.g. age, gender, place of residence), disease / condition-related data (e.g. diagnoses, disease severity, genetic characteristics), treatment history (e.g. surgical interventions, radiation treatment, oral therapy) and even behavior / way of life (e.g. physical activity, nutritional regime).


In oncology, it is estimated that RWD make up at least 96% of the total pool of clinical data, while clinical trials make up the remaining four percent. (Roche, 2020)


Health services research is a multidisciplinary field of research that examines the structures and processes of healthcare from a patient and population perspective.

The focus is on the appropriateness of treatment and the improvement of care. The task of healthcare research is therefore to identify deficits in healthcare, to participate in the development and implementation of new care concepts and to evaluate their effectiveness.


The examination of care needs, care structures and processes, the services provided and the improvement in health and quality of life, as well as the direct relevance of the research results for health policy decisions, are characteristic of health services research. (ZVFK, 2018)


Through our knowledge network, we are able to collect, manage and evaluate high-quality RWD according to the project specifications of our customer. Using real world data, factors such as the cost effectiveness and benefits of new diagnostic methods and therapies can be assessed and the use of medical approaches (e.g. therapies / devices) in medical practices can be examined.


In addition, using RWD makes it possible to build health economic models that aim to assess the cost advantages or disadvantages of treatments with drugs, vaccines and other approaches.



PROMs and PREMs are a large family of patient-centered tools for assessing the impact of health interventions from the patient's perspective.


Some of the most widely used tools today are EQ5D, AQLQ, OHS and OSS, with many country-specific variants of these tools developed around the world.


Results reported by patients and empirical values ​​as well as data for measuring satisfaction are playing an increasingly important role in clinical research. This tool offers a valuable overview from the patient's perspective and often run parallel to medical therapies, clinical studies and follow-up documentation.


By using PROMs, PREMs and satisfaction surveys, we are able to record and evaluate parameters such as mortality, morbidity, quality of life, quality of care, patient satisfaction as well as direct and indirect therapeutic effects.


In addition to using validated and internationally recognized questionnaires, we also create customer-specific surveys tailored to the desired project.

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Our statistical analyses for market research services can be tailored to the needs of our customers in order to achieve the highest level of flexibility and efficiency in accordance with the goals of our customers. The data collection within the framework of the project ranges from anonymized patient surveys to the analysis of registers and the presentation of specific questionnaires for the BNGO's network of doctors. The successive statistical evaluation takes place according to the focus of our customers and can thus offer effective support in decision-making processes.

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