Cromos Pharma delivering high quality data for clinical trial success

Effective data management and biostatistics are crucial for producing high quality data for successful clinical trials. At Cromos Pharma our expert data management and biostatistics team provides innovative solutions to ensure transparency, data integrity, and quality of your data.

Clinical data management is a vital process to help generate high-quality, statistically sound, and reliable data from clinical trials. Choosing the right partner to outsource your data management and biostatistics is an important decision. Sponsors need first-rate and trustworthy data to gain approval from regulators for new drugs and therapies.

Cromos Pharma is a data focused CRO with vast experience in delivering expert data management and biostatistics solutions to international pharma and biotech sponsors. We offer a full range of clinical data management and biostatistics services utilizing internal teams as well as long-established, trusted alliance partners from the European Union and USA. The use of internal as well as outsourced resources ensures that Cromos Pharma is able to deploy the very best in niche capabilities on a study by study basis.

Clinical Data Management

Our team of Clinical Data Managers deliver high quality and reliable data from Phase 1 clinical trials to postmarketing studies. Services include:

• Customized database design/validation
• Data entry screen design/validation
• Double data entry
• Programming SAS
• Data coding
• Data validation (manual check, computerized edit checks, medical expertise)
• Data listings
• Presenting data in the format and structure convenient for the client
• Data transfers

Biostatistics

Our team of biostatisticians offer biostatistics and SAS programming services, in full compliance with ICH guidelines and CDISC/ADaM data standards. Services include:

• Study design consultation
• Study protocol development
• Informed Consent Form preparation
• Sample size calculation
• Randomization code list generation
• Statistical analysis plan development
• Statistical analysis programs development and validation
• Statistical analysis conduct
• Programming of SDTM datasets at beginning of study and to assist in analysis
• Generation of reports from appropriate analytical tools and to assist RBM and QC of study data
• Generation of customized tables, graphs, and data listings
• Statistical interpretation of study results
• Mining of study results descriptions in medical narratives
• Study report writing
• Assistance in preparation of study results for presentations
• Assistance in manuscript preparation

Contact us today by emailing bd@cromospharma.com to find out more about Cromos Pharma’s Data Management and Biostatistics solutions.