Non-Interventional Studies: Real-life data collection and analysis

Non-Interventional Studies (NIS) offer a unique perspective: these epidemiological or observation studies refrain from study-related interventions, allowing us to collect and analyze real-life data from routine patient treatment.
Our proprietary digital sys-tems facilitate the seamless collection and analysis of these data, providing a comprehensive view of medical practices. NIS rely on medical practice. Thus, experienced physicians and study nurses are key, emphasiz-ing comfort in documenting patient data through well-defined observation and evaluation plans.

Meeting the increasing demand for real-world data on marketed drugs, non-interventional and observational trials play a crucial role in post-market drug information.

In our collaborative approach to conducting NIS, we engage with Key Opinion Leaders (KOLs) to expedite setup and increase investigator awareness. Leveraging our expertise, we ensure proper design, quality planning, seamless implementation, and meticulous evaluation and reporting.

From document preparation to intensive site support, our comprehensive services cover all aspects of NIS, providing tailored solutions based on your unique preferences and needs – from registration to final evaluation.

For NIS, we provide you with the following services

Quality Risk Management

One of the most important developments in clinical trial conduct during recent years is the advent of risk-based thinking, introducing a paradigm shift from controlling quality
read more ..

Project Management

Any project requires an adequate initiation, planning, controlling and finalization. Specifically clinical research, with its regulatory requirements concerning trial application
read more ..

Regulatory Affairs

Approval of relevant study documents by competent authorities and ethic committees is the key requirement for setting up a clinical trial. A concordant positive
read more ..

Monitoring

Monitoring of clinical trials is a quality assurance measure to ensure patient safety and data integrity. Typical monitoring activities are the "Source Data Verification" (SDV) and
read more ..

Data Management

Clinical Data Management is the crucial interface between acquisition and interpretation of essential data in clinical trials. Core to data management is the structured design
read more ..

Medical Writing & Medical Monitoring

Medical writers accomplish the challenge to cover the width of the medical disciplines in order to develop sophisticated scientific documents or delivering supporting clinical development
read more ..

Statistics

The primary function of statistics is to handle uncertainty in a rigorous fashion to arrive at accurate inference and decision making. This is especially important in clinical research
read more ..

Technology (eTMF, EDC, CTMS, ePRO, Safety Data-base, EudraVigilance, and more)

One of the most important developments in clinical trial conduct during recent years is the advent of risk-based thinking, introducing a paradigm shift from controlling quality
read more ..

Any project requires an adequate initiation, planning, controlling and finalization. Specifically clinical research, with its regulatory requirements concerning trial application
read more ..

Approval of relevant study documents by competent authorities and ethic committees is the key requirement for setting up a clinical trial. A concordant positive
read more ..

Monitoring of clinical trials is a quality assurance measure to ensure patient safety and data integrity. Typical monitoring activities are the "Source Data Verification" (SDV) and
read more ..

Clinical Data Management is the crucial interface between acquisition and interpretation of essential data in clinical trials. Core to data management is the structured design
read more ..

Medical writers accomplish the challenge to cover the width of the medical disciplines in order to develop sophisticated scientific documents or delivering supporting clinical development
read more ..

The primary function of statistics is to handle uncertainty in a rigorous fashion to arrive at accurate inference and decision making. This is especially important in clinical research
read more ..

Related Resources

About us

 

„The effect of strong minds working together is powerful.“

read more ..