Clinical 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, site selection [more]
• Protocol writing and review
• Regulatory and Ethics pre-study activities
• CRF/eCRF development
• Project management [more]
• Site management, contract management, site reimbursement
• Clinical monitoring [more]
• Data management [more]
• Statistical analysis [more]
• Medical writing [more]

Observational studies

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.

Electronical data capture (EDC) is becoming increasingly important, as it offers the potential of further increasing speed and efficiency in gathering clinical data. Our activities with EDC go back as early as 1995, and we have accumulated considerable experience with EDC for observational studies since then. Our proprietary EDC system, REDCAS®, is tailored to the cost-effective management of observational studies.

Medical imaging

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 continously grown to unite competence in classical clinical research with comprehensive, in-house expertise as an Imaging Core Lab.

Why MEDIDATA Imaging

• 15+ Years of experience in a variety of indications and modalities [more]
• Trained and experienced imaging staff
• Network of contacts to expert reviewers and specialist readers
• Breadth of expertise available in a full service CRO (including monitoring, project management, data management, and medical writing) [examples]
• Seamless handling interface and one-stop analysis of imaging and clinical data in integrated clinical studies
• Standardized processes and validated imaging software [more]
• 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. [more]

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 in logistics and setup as well as ongoing efforts on data collection than pre-registration trials. 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). [more]