Data Management
In a fast-moving world of clinical research it is important to have a dedicated and focused partner able to provide assistance and expertise you need.
In a field of data management, with well over 20 years of experience, Clinres Nova can offer the whole range of services and solutions for your business. We can work with you from the initial phases of study planning or join the team when data collection is either under way or done completely. Regardless of the scenario, our expertise will allow you to proceed from raw data to meaningful study report in desired format (usually ICH E3).
Data management is much more than just collecting the information from clinical study and exporting it to the client in an usable format. Clever data management begins long before the study inception with protocol design and approval (by client and ethics committee) and development of the CRF which can be paper or electronic.
Our data management plan describes the methodology used in handling the data throughout the study, defines crucial timepoints, study conduct procedures as well as flow diagrams and responsibilities.
Following are design and development of database and double data entry onto it. Two entries are first compared automatically to reveal major discrepances, and then manually, variable by variable and case by case, to assure data quality before the actual analysis even begins. Queries, normally generated during the data entry are created at this point as well.
Finished database is reviewed, additionally coded if needed (e.g. MedDRA, Costart etc.) and transferred to the client following client's format specification or Clinres Nova's SOP.
Phase IV Specialists
Although having both expertise and experience in all phases of drug and medical devices development, we are especially proud of our Phase IV projects in Europe and Middle East.
From a single-centre to multi-country international studies, we offer an one stop solution in managing our clients' data. From paper or electronic CRF to the final report according to client's, ours or EMEA's specifications, all phases of data management are covered by our services. Our clients can check data management and study progress status practically in real-time, logging into our web pages and tracking all events ass they happen.