MEDIDATA GmbH – CRO for Phase II to Phase IV Clinical Trials

MEDIDATA GmbH is a contract research organisation (CRO) that has been providing end-to-end services for phase II to phase IV clinical trials and for observational studies for more than 25 years.

Since 1995, we have also excelled in trials involving medical imaging (oncology, neurology, radiology) and in trials with medical devices. Currently employing over 60 professionals, MEDIDATA GmbH combines experience with the quality, dedication, and flexibility of a midsized organization. Our continuously high level of service quality has nurtured long-standing partnerships with leading sponsors.

We are proud to be among the very few CROs worldwide, whose range of services covers all tasks in pharmaceutical or medical device studies, even including the responsibilities of an imaging core lab (ICL). For almost any trial you can think of, we provide the expertise you need for turning data into results.

Phase II to phase IV clinical trial research

Over 25 successful years of planning, performing, and analysis of clinical trials have created a solid experience base at MEDIDATA. This includes:

• Study planning, setup and site selection
• Protocol writing and review
• Regulatory and ethics pre-study activities
• CRF/eCRF development
• Project management
• Site management
• Clinical monitoring
• Data management (paper, EDC)
• Statistical analysis
• Medical writing

Observational studies and electronic data capture (EDC)

Since the company's early days, MEDIDATA has managed a large number of observational studies (non-interventional studies, post-marketing surveillances) in different indication areas. In keeping with the character of this study type, we foster a tailored approach, adapting objectives, extent, and quality standards optimally in cooperation with the sponsor. Specific in-house software for data entry, coding, and evaluation provide excellent efficiency in very large projects. Electronic data capture (EDC) is becoming increasingly important, as it offers the potential of further increasing speed and efficiency in gathering clinical data. Our EDC activities go back as far as 1995, and we have accumulated considerable experience with EDC for observational studies since then. Our proprietary EDC system, REDCAS, is optimised for cost-effective management of observational studies.

Medical imaging for oncological and neurological studies

The rapid increase in the importance and sheer number of radiological images in oncological and neurological studies has raised technical and methodological issues for CROs. Thanks to our software development capacities, MEDIDATA was well-equipped early on to handle the challenges of quality management, format issues, and image presentation. Thus, MEDIDATA has continuously grown to unite competence in classical clinical research with comprehensive, in-house expertise as an imaging core lab.

Why you should choose MEDIDATA imaging:

• Over 15 years of experience in a variety of indications and modalities
• Trained and experienced imaging staff
• Network of contacts to expert reviewers and specialist readers
• Breadth of expertise available in a full service CRO
• Seamless handling interface and one-stop analysis of imaging and clinical data in integrated clinical studies
• Standardised processes and validated imaging software
• Flexibility, dedication and customer-orientation of a mid-sized CRO

Medical devices

Medical device manufacturers are facing increasing requirements on data from clinical trials data. Thoroughly familiar with current EC Guidelines and the corresponding implementation in German law (MPG) in accordance with ICH-GCP, we can offer distinctive know-how for clinical trials with medical devices.

Post-marketing surveillance

Even after your commercial launch, we can assist you in meeting post-marketing surveillance (PMS) requirements. However, these studies necessitate a different approach to logistics and setup, and data collection is typically ongoing. Therefore, we have a dedicated PMS department at MEDIDATA enabling rapid setup and cost-efficient management of such studies. Studies can be designed as either paper-based, as EDC, or as hybrid studies (paper CRF + EDC).

Medidata GmbH
Max-Stromeyer-Str. 166
78467 Konstanz
Germany

Tel: +49 (0)7531 94238 00
Fax: +49 (0)7531 52782
info@medidata.de
www.medidata.de