EFFICIENT PLANNING FOR YOUR STUDY SUCCESS

Efficient planning and preparation for your smooth study

Building on our experience and expertise, we ensure efficient planning and preparation of your clinical trial. With us at your side, you ensure that all necessary steps for a successful study project are implemented.

COMPREHENSIVE PREPARATION — SOLID STUDY FOUNDATION

Thorough study planning for the guaranteed success of your study

Building on our experience and expertise, we ensure efficient planning and preparation of your clinical trial. With us at your side, you ensure that all necessary steps for a successful study project are implemented.

Creation of essential study documents

On the basis of the study plan, we prepare further essential study documents (e.g. statistical analysis plan including case number estimation, data protection concept, patient information and consent form, processing list) for submission to the competent authority (e.g. BfArM) and ethics committee.

Cooperation partners and opinion leaders

The right cooperation partners are essential for the success of your study. Thanks to our many years of experience in various indications, we can draw on an extensive partner network of suitable study centers and opinion leaders to recruit the right patients for your study in good time. We are happy to support you in selecting and approaching suitable cooperation partners and take over the complex administration of the contracting process.

To respond to the increasing shortage of resources in clinical study centers, we can bring in additional medical study staff to provide on-site relief.

Study preparation with authorities and ethics committees

We will be happy to support you in preparing talks for consultations with the responsible authorities or take over further communication in the study implementation. We support you in the application process, consultations with competent authorities and the registration procedures for your study.

YOUR CUSTOMIZED STUDY PLATFORM

Optimize your study process through effective technology

Building on our experience and expertise, we ensure efficient planning and preparation of your clinical trial. With us at your side, you ensure that all necessary steps for a successful study project are implemented.

Development and system validation

We create, test and validate a study platform that meets the requirements of your study. To accomplish this, we perform a standardized documented system validation process and a logged test procedure to ensure critical system functions.

Test run and troubleshooting

After the successful test phase, we conduct a trial run with independent persons to identify and eliminate possible sources of errors before the study platform is released.

Focus on quality control and compliance

Consistent quality assurance for uncompromising compliance

Our experienced team is at your disposal during the entire planning and preparation phase and also accompanies you in later stages of the study implementation. In this way, we ensure that your study complies with current guidelines and runs smoothly.

Monitoring, quality assurance and data management

Our established monitoring, quality assurance and data management concept ensures that your study complies with current guidelines and is of high quality. Our experienced team, with an average of more than 10 years of experience, accompanies you in this process.

FROM EVIDENCE TO MARKET-WIDE ACCEPTANCE

Over 30 years of experience in study design

Our many years of experience in study design enable us to offer you effective and customized strategies for your products. With us at your side, you can be sure not to lose valuable time in developing a suitable project strategy.

By collaborating on strategy development, we lay the foundation for the success of your trial. Our goal is to support you every step of the way in developing your medical devices or digital health applications to achieve the best possible results.

Contact us today for a personalized consultation!

From data preparation to statistical analysis - our experienced team of scientists and analysts will support you in your next research project. Trust in our expertise and let us find the answers you are looking for together.