Our statisticians can contribute in the design of clinical programs and clinical trials to help optimize endpoint selection, sample size and power calculations. Modeling and simulation are helpful tools to ensure all available information is utilized in the design phase.

Scenario planning for go-no-go decisions as well as further exploratory data analysis are often crucial in the interpretation phase, this is where our statisticians can help companies understand the data and ensure informed decision making.

We provide you with state of the art biostatistics services by highly experienced pharma professionals to ensure the successful management and delivery of clinical trial data in accordance with your timelines and budget.

• Study design
• Protocol development support
• Sample size calculation
• Detailed Statistical Analysis Plans (SAP)
• Support for Data Monitoring Committees (DMCs) and Data Safety Monitoring Boards (DSMBs)
• State-of-the-art statistical analyses
• Support for regulatory submissions (incl. EMA, FDA)
• Interim and meta analysis
• Publication support
• Statistics for integrated summaries of safety and efficacy
• Statistical analyses of Real World Evidence data to support market access

Our statistical programming team has long experience from working with all types of clinical data. They optimize the data structure, ensure data standardization and submission readiness. In addition, data visualization and presentations are prepared for different stakeholders.

• Source data sets (including SDTM)
• Analysis data sets (including ADaM)
• Data listings and patient profiles
• Summary tables and graphs
• Development and validation of SAS macros
• Data pooling and integration
• Risk-based monitoring data presentations
• Conversion of clinical databases into CDISC data models

High-quality, cost-effective solutions to ensure the successful collection, management and delivery of data in accordance with your protocol, timelines and budget. We provide you with highly experienced pharma professionals to support you in these processes.

We act in senior roles to set up your data management process and environment, to plan activities, to supervise other service providers and to communicate with your partners and regulatory authorities.

• eCRF design
• Electronic data capture (EDC) by using ViedocTM
• Customized database design and set-up
• Documentation including data management and data validation plans
• Data validation and discrepancy management
• Serious adverse events (SAE) reconciliation
• Status reports
• Data migration
• eData transfer
• Medical coding using MedDRA, WHO DD, and ATC dictionaries

Our medical writing services include clinical and regulatory writing, as well as scientific papers, education material and medical writing consultancy

• ICH compliant clinical study reports (CSRs; Phase I to IV including pediatric)
• NI-PASS compliant CSRs
• Study protocols, amendments, and administrative changes
• Regulatory documents (e.g., briefing books, summaries, overviews)
• Investigator brochures
• Patient information/consent documents and narratives
• Manuscripts
• Conference abstracts (posters and slide sets)
• Medical marketing reviews and reports
• Promotional and educational material

We utilize technology to support patient safety data collection, analysis and reporting. We ensure an effective data flow from individual studies to the safety database as well as an integrated safety database. A visualization tool can be set-up to provide sponsors a clear overview and facilitate signal detection. Summary reports to authorities are quickly produced.

• SAE reconciliation
• Medical coding
• Safety data review package for safety committees
• Integrated safety database
• Tables, figures and listings for DSUR, IB, ISS
• Signal detection database searches
• Safety data visualization