Healthcare data
Hospital Information Systems
Crossover provides generic and customised solutions to enable access to healthcare and administrative data that are stored in the hospital information systems (HIS) for the institutions belonging to the Crossover network. Data access is strictly controlled and subject to the relevant data privacy laws and regulations in force at each institution. Crossover uses HIS data in three different ways:
- to screen for eligible patients and project future trends based on protocol inclusion and exclusion criteria
- to create repositories of HIS data that may be used either directly or indirectly to automate clinical trial data processing and hence enhance trial performance and improve data quality
- to create a world class secondary (epidemiological) research database by combining suitably anonymised HIS data from the many institutions that belong to the Crossover network.
Electronic data capture systems (EDC systems)
Crossover provides expertise and technical solutions to enable the integration of sponsor EDC and other automated data capture systems at healthcare institutions and in the Crossover clinical research units (CRUs) which it operates. In addition Crossover CRU and technical staff are available to work directly with sponsors to train and support investigators and other site staff regarding data, telecommunication and infrastructure solutions. The scope of this activity includes:
- electronic CRF data
- electronic device data, e.g., spirometry
- PRO and ePRO data
- laboratory data
- imaging data
Feasibility
Clinical trials
Secondary research
Crossover has exclusive access to medical data for patients treated at healthcare institutions that belong to its network. In addition, Crossover employs staff who are experts in the structure and management of several different hospital information systems, and has developed a methodology and an automated approach to enable the rapid identification of patients who meet protocol entry criteria. The system can also handle scenario analysis, for example based on variations to the original protocol to allow sponsors to easily and efficiently identify expected patient numbers based on alternative combinations of entry criteria.
Clinical trials
Much of the data held in the HIS is the same as that which is required for clinical trial purposes. In recent years, research has intensified to develop solutions that will integrate HIS and clinical research needs. For each institution in the Crossover network, the "pocket" of data held in HIS that is also needed for clinical research purposes (both feasibility and clinical trials) has been defined and is held separately in a set of "mirror" tables within the HIS system. These "mirror" tables are encoded, where appropriate, using the standard coding systems in use for clinical research and regulatory approval purposes – namely CDISC, HL7, MedDRA.
Secondary research
Crossover has an agreement with the institutions belonging to the Crossover network to create anonymised datasets from the HIS that can be exported, consolidated and held in a data warehouse for secondary processing and exploratory research purposes. The data warehouse includes referral and patient information, results from laboratory tests and other procedures as well as interventions and prescription information. The data warehouse is structured for analysis and reporting purposes and uses standard coding nomenclature to enable data to be easily merged with information from similarly structured research databases. Crossover employs statisticians, epidemiologists and market researchers to answer key questions of scientific, medical and commercial interest.