Clinical Data management Services is essential in clinical development and it influences the quality of data received from investigative sites and of that delivered to the statistical and medical writing groups. So an interactive collaboration between data management and other disciplines of the clinical development process is needed. Our Data Managers average many years of experience in the pharmaceutical and CRO industry and have worked on a wide range of projects both full service and stand alone, EDC or Paper-Based CRF projects. So they are used to achieving the collaboration necessary for successful results.

Our meticulous attention to detail has resulted in a successful history of completing data management tasks on time and within budget. And it is this depth of experience that ensures we’ve got the processes and policies in place to effectively focus on high-quality results. Our data management specialists are actively involved and accessible from start to finish in order to ensure that the data captured support overall objectives and all necessary regulatory requirements.

Our Clinical data management services include:

• Case Report Form (CRF) design
• Database design
• Data management plans/guidelines
• CRF management
• Double data entry (when Paper CRFs are used)
• Data validation and review
• Medical coding (WHO, MedDRA®, etc.)
• Edit checks and data queries
• Electronic data processing/reconciliation
• Data migration

The key to a successful working relationship and part of our customer excellence approach with our clients is being flexible to their requirements. Therefore, our Lead Clinical Data Managers will work with our partner customers to define specific requirements and expectations to meet the partnership objectives.